perticépatig faa qx earn thi DANG BAI CAU HOLLUA CHON Tay An 4 Choose the best answer A, Cor Dto complete the following sonences & Tomes! om artspntng spend sift )Partcinatng en Choos the bet answer A, C oD compete Orr blisne = toads cal Toney. nso gagonlion-ped exertion ae observedad docrsented lip th A.climination(4¥feabolis}0. exchange Deobseration @bSeaphion «Cap He Choose the best ansvgPASE=COFD 1 complet the followin cones, was the puls rate ineteasd, the blood pregage was bigh, A’Both/and DB. Neier ner |. Bither/or at only /butalso Choose the best ansver A, B, Cor D to copalae te filawing Ou gn ties shoved that he Shortage tempera hath unwanted effet onthe substance, (esis Breoont Coprevious De next 6 CChodstthe best answer A,B, Cor Dto complet the flowing sentences, T would like to zisl my healt si in clinical trials. subject "FB. topic C. theme D. Allare correct, Choos® the best answer A, B, C or D to complete the following sentences. Heavy drinkers ate more... than subess in clinical ils Avin risk B. on risks C. in risks Ose CChoose the best answer A, B,C oF D to complete the following senten Volunteers ... a big contribution... the field of medicine, no matter what their motivation is, ‘A take/ in B. have! in C. give! to ake/ to Choose the best answer A, B, C or D to complete the following sentences. “~~ 1 serious ill, vs efigitely take part ina clinical study. Iteould be my last hope! ‘A. was/ would B. am will ‘would DD. were/ wouldhave = W Jy fences, is the study of A. Pharmacy ities. Pharmaceutical a ‘or D to complete the following sentences. Spier nee Toxicity isthe study o risks tothe body nfiok J ‘A. impossible Potential C. possible D. potency Choose the bet nsw 8, Cs ia Bini aang Se a The patient reported not having. had anything to eat . {chocolate eandy bar four hours beforehand ‘Acand On: C.or D. except Choose the best answer A, Be@or D to complete the following sentences. Lasyenr, results of preclinical testing were used to come up with the best formulation of the onsen dru : |. OM Gintenies B. intending, C.intend. Duinends Uline; dv dh. Choos the best aiswer A,B, Cor Dt The general health and behayjag of fhe dogs)... rf ‘A. examined checked C. D. istested ‘Choose the best answer A, BYE or D to com Ik ™ to hurmans are determined in@oxisity studies) ‘A. Extensive documentation B 3 C- Intended drugs Or jal risks Choose the best answer A, B, C or D to complete hefollowing sentences. The anj ‘showed clinical symptoms were separated ...e:xee« More intensively, faiched _B. to-watch . watching . to watching nswet A, B, C or D to complete the following sentences. “ me a copy of your report on the clinical _as soon as possible?Qdrwrmscaogy, pharmeegkinetics, toxicology and(feferences_ ) ; All are not correct = Choose the best answer A, B, C or D to complete the following sentences. ACn) is @ type of single-use plastic container, and is used for pharmaceutical products as well as for ofr consi sosssse The product is placed in the formed eavity and sealed by lidding foil ister pack/ goods B. syringe/ products ‘sachet’ goods D. sticky label/ produets ‘Choose the best answer A, B,C or D to complete the following sentences. overs how to design and construct buildings $0 thatthe «..-s.c! seed -. can be cleaned easily. A. devices and methods/ opt ,,and so that they ed B. type.of clothing/ standard C. flow of materials/ minimized are not correct Choose the best answer A, B, C or D to complete the-ftllowing sentences. A(n) is a multi-use glass container with a twist-on lid. It can hold pharmaceuticals, or any kind. of fl are used up. ‘A. sticky label/ the contends ia! the contents C. sached/the contents ‘hister patib-ihe contents Choose the best answer A, B, C or D to complete the following sentences. Lab technicians also check the samples for «......-...,and so on. O= Packaging, content humidity B. content testing, content weight lontent uniformity, ase , content temperate, content analyses Choos the best answer A, B, Cor D to-complete the following sentences. A(n) is a piece of paper attached with adhesive to the ..... to identify it and give details agceming nature, and/or use. Ghy label / wing B. syringe/ secondary packaging, sachet/ prim iz D. blister pack/ secondary packaging. ‘Choose the best answer A, B, C or D to complete the following sentences. Common Technical Document Summaries are overviews of A. biological, clinical and non-clinical data pharmaceutical doct clinical and non-clinical data Qa acl nt clinic! data j ranfacturs, clinical and-non-clinical data Choose the best afiswer A, B, C or D to complete the following sentences. Administrative is the general information, such as marketing authorization form, as well as ot solids. It ean be opened and "Ore. times until... ‘A. product characteristic and quality control ‘manufacture and labelling Ons characteristics and elliss> ‘manufacture and quality control ma best answer A, B, C or D to complete the following sentences. ce the u Carn areas such as the type of clothing to wear while working, the ... training that .. get on a regular basis. ‘A. analyses /employers repor/ employee C. SOP/ employers a‘ “umentatior cS Se Soeaeaber long the product will hold up under uring the product process, testing at the «.. certain conditions ike temperate and humidity. that is necessary, and A standard B. critical D. packaging ‘Choose er A, B, C or D to complete w der products onto the market, lab techn Lame nts and ¢xcip A raw materials and excipients (1) D. Both (1) & (2) are correct ie — titer pho en Mio" sacl « flv es = axCipiends » fala - an,foleretts The drug was well flea by rat vee ig not have any effect on blood pressure, A. However B. While D. Whereas che ve (Low-dpke, fid-doss, high-dose groups are three groups of animals wh f The overall appearans) and ... (W we Que sah A. informationB. testing C/observations D. documentations ‘Choose the best answer A, B, C or D to wf lete the following sentences. ‘the other animals, but .... the In an experiment, a control group is treated just. ingredient. ff . ‘A-asido notreceive B. as/receivesC. like/ receive (‘Dpikel docs not receive Choose the best afiswer A;B;G-or D to complete the following semfences. 7 e hich receive different concentrations of \ sos Undef study 9 - A. meditation B. treatment C. dosage Cofresication Choose the best answer A, B, C or D to complete the following sentences: sve of each animal was assessed twicg.a day. ae A. behave B. behaved C. behavioral havior Laks i Choose the best answer A, B, C or D to complete the following senten¢ fx 09 C. obtain D. proceed Chooséhe best answer A, B, C or D to complete the following sentences. ce el there were no clinical findings in the mfid-dose group, the high-dose group animals Clinical symptoms. = pis ‘A. However/showed Qe gore C. Furthermore/was showed D. NobSflly/ was showed ‘Choose the best answer A, B, C or D to complete the following sentences. Choose the best answer A, B, C or D to complete tR€“following sentences. Phase I Trials are done to find out how the drug ... Se boiy. A. works B. respond « Pets pho > D.allofthe above Choose the best answer A, B, C or D to complete the following sentences. ‘A condition in which a part of the body becomes red, warm and swollen iscalled «.. agammation eB. itch sneeze D. cough B, ‘Choose the best answer A,'B, C or D to complete the following sentences. Phase [Trials are performed on ..........-+... anda number of patients with the target disease or disorder. olunteers B. subjects ats D. animals Choos® The best answer A, B, C or D to complete the following sentences. ‘Minicpigg are easy to . whereas rhesus monkeys are difficult to work with, yandle yg! ty 8. hand C. snatch D. grab Choose'The best answer A, B, C or D to complete the following sentences. ‘An adverse event is any abnormal medical occurrence in a patient or clinical trial subject after a medicinal product has been . 2 A. seen B. managed C. produced ‘Choose the best answer A, B, C or D to complete the following sentences. The doctor gave her a strong Gedativé)and took hi the medication. ‘A. down B. into D.on Choose the best answer A, B, C or D to complete th&following sentences. Un ‘do not have a r is yo eSB. treatment group ’ = . experimental = mei xpermental ©OUP acted «ye |, C or D to complete the following sentences. ieee ‘caused by a drug or medical treatment. tended: pe BB. adverse event Sea A oats D, All are correct Choose B,CorD to complete the following sentences. Sena sis to pain, enced headaches and insomri. a Before r D. lowing sentences. discovered soon pes adios - quay he e, mptoms b c xe best ensyee aS C. its D.record, 5 CFD 10 complete the follow cw DOL pete the folowing sentences een Mensenit an Haale ‘A. relationship regen” MMe ganrtoms cannot be ruled out, relation D. connection i Hay Cd Choose the best ansi Tri peat ¥e" By CorD to compe the illowing serences patie sea of dv. desomme ov glia i on. ny i he a ope at he Clayfoe A. would be Qhusrbetested _C.naveio be tested D. ought to st (Choose te best answer A,B, CoD to complet the fllowing seers egulatory agencies have to give mpenge si ical testi ich Reznor ape ~ogoupenge with the linia aig. Which aoe O: ermission / humaps Clastudy of / animals Oe Choose the best answer A, B, € oD to complete the following sentences. Extens)ye documentation 1. to the approprigge regulatory authorities Should be conducted D. can be determined Choose the best answer A, B, C or D to complete the following sentences. This morning when I wanted to take blood and urine samples, I saw that some of the dogs ‘A. have been vomiting ni kee (B) Ratt been Comiting Cleeaail Oe ee Choose the best answer A, B, C oF D to complete the following sentences. A .c-nore BfOUp in pisslinical studies is a group of test animals that is not exposed to the medication under study ae Pie A.experimental —B. subject trol D. treated Choose the best answer A, B, C or D to complete the following sentences. Phase IV Trials are post-marketing studies after getting . for general sale. They are... in order to gather further information about the drug’s safety, efficacy, and optimal use i approve / done Be approve / performed golfer fi Ome@ “i D. approval / made gure |fephks ing To a Le gig ha “Choose the best answer A,B, C or D to complete the following sentences. ical trials, (fees) two different animal models are necessary. They are rodents, e.g. 1als which have Systems more similar to humans, ©. - Ly aft py mouse dog. monkey BB. guinea pigs, monkeys! mice, rats baat: Gs rats dogs, mnini-pigs D. dog, rabbit’ mouse, rat Choose the best answer A, B, C or D to complete the following sentences, tagitdent ‘The active dngeedian! can be tested in humans only after preclinical tests have been successflly completed Vs and has been given. i * ee ‘Aidosumentation — B. permission C. informatiog@D)puthorization @) Choose the best answer A, B.C or D to complete the following, lini is ir i however there were There were no clinical Gndiogs in the.... n. studies, in te iggaveanus-dose studies fans, & (Ball mB omlly trials C.eating/testing* D. speaking /symptomis fre acg, qp og ‘ery sacl +1 Choose the best answer A, B, C or D to complete the following sentences During the «20... ofa drug, laboratory tests document the .. ving organisms (in vivo) and in cells ina test ‘tube (in vitro). (Gps soap /GBSS0_B. preclinical technology /obtain “preclinical stage / affect . preclinical tral / receive Choose the best answer A, B, C or D to complete the following sentences. These are studies evaluate the safety of drugs in healthy people, and ........, i) Pharmacological proy f drugs. Pei Gi 2 Sn A, which tee on deeminle Qich we pi Shain ©. which are conducted are determi all ofthe above” {Choose the best answer A, B, C or D to complet the following sentences In hase I ils testing determines the safety and... of the dru in eating the condition and ire minimum and menimun sileie das en ihe cient! establish B. effect established acy! eapbisies) D. eflicacious/ establish paceet sas (ep oh cacy hide que ‘Choose the best answer A, B, C or D to complete the following sentences. is any . medical in a patient or clinical trial subject inal product has been administered. fee a A-normal /before ~ que Uj I bnormaD)after ‘ . abnormally / during normally / when Choose the best answer A, B, C or D to complete the following sentences. Many people don’t(realize)that animal qials . by law, before testing in humans can é ‘ recat : A. is required / take part (P&Bresuize tke place C. were required/ take place D. was required/ take part Choose the best answer A, B, C or D to complete the following sentences. Ina controlled study, one group of test subjects is eGo tothe gusance, while the. isnot Rien pon Being experimental group 1 eroup Choose the best answer A, B,C oF D to complete the following sentences In trth, clinical trials are ined a aTS¥e oo L ist ent linia nial neinly hor yeh A. satisical nie mi ruined Ad SSircoge the best answer A, B, Cor D to complete the following sentences. eh In general, their goal is to r Bre” determine p effectis but fi dea Det Blinn ei ; Avexperimentsl— is v4 D. Both A and B are correct inswer A, B, Cor D to complete the following sentences. f Se rigs eee tat 3s life, requires or prolongs fospitalization, or results in feveeee 18 an re, renters ae bei « , reaction {dead Serious adverse reaction Salou ade de Gs educa . Serious adverse eveni/ dead following sentences. Siceagaiapeese espns en esigiolmetcil pt rl 1) tele qa dose admi (en dy i s a - see reac hin + ee a beepernx cacute ace of ‘normal and intended ee normal and unintended en and intended sabe anne wer A. B, Cor D to complete the following sentences. 4 orwvanted media cc emrnans elon Qua hit ‘Choose the best answ quinwnisl Gaeeee ‘A,B, C or D to complete the following sentences pharmaceutical eo Heo. 3 quane fad evaluate panies, and healtheae professionals work together to «72 : ee ae monit sia of drug B, monitori sotdra . monitoring / causes of dru Cees fety of drugs. 1D. monitoring / safety of drugs. 3 Choose ie best answer A,B, Cor Df compl the ollowing sens pharmaceutical company can start clinial testing in humans when the regulatory authorities the gamgencement of linia studies. e Oo Jauthorize B. assent C. ancept ov peste ep D. approve ttheg Choose the best answer A, B, Cor D to complete the following sentences t ‘A eyo Panag eT ee re ner ergonine walter eaeee) i yh e Leer ceyae ane te at Ny phad fainted{inflammation> . _B. have fainted/ itching q feet ar Di wer bed bo Choose the best answer A, B, C or D to complete the following sentences. ‘We started the trial after tests on = five years. (P6/42) A. intended / in to C. formulated /10 jvo_and in vitro over a period of development Choose the best ansne A Br D to comet he following sentences. + She reported gufferingrom| % Ineadaches, and j int ou three we slyi4af ve ace Ta if @ ‘sjarting of) B. troubles / use dao. alfacks / take on | D. diseases / drink Choose the best answer A, B, C or D to complefe the following sentences. After 24 hours, all symotoms ze xcept for a mild skin fritatlog end the patient was Asethegs Bests . were subsided / saved 'D. have been subsided / delivered Choose the best answer A, B, Cor D to complete the following sentences, raced sige effects of Mensamint although o,someaion between her peanut eet ‘and this event cennot be at Tas cb teg “ ¢. Synéromt t A. Signals B.Signs Choose the best answer A,B, Cor te epee following sentences. ‘Test subjects in the speatmer under study, whereas the control group receives coe aa gard medication ere) efecctonl & edication/, ie yee iv dea Ce information/pair-kiler : B. evgenelaalgesie pee bea anaes Bsc psp complete n= ollownB -emeTe= edCochacep duce ten$ Wes | Hr She is taking another drug, an oral...» nd has a historyoF hypertension, mild heat... high acrengling sad ines & >) plating) Le drug / attacks D. placebos /diseases Fhoose the best answer A, B, C or D to complet the following sentences. fg) NEY” The... : . for the new dos ‘form. int wil it vd ‘of Mensamint will be submitted to the .. A decent 1, dovumeniton/ regaltey fie '. document/ regulatory affair Cidocumencati See best answer A, B, C or D tocomplete the following sentences. * oe ry agencies require testing that ........... the characteristics and chemical composition of the anes! formulated D. note down/ formulary. Choose the best answer A, B, CorD tocoms fr hoos cA, B, plete the following sentences, Gy ii... ofa drug in.vivo and in vitro needs to be documented in \The effect/ laboratory tests B. The affect / reality tests = The reaction / aborstony tests D. The effects real tests Ferrets a woes, teler to vali ts da, c i esc QR oval fe als ier "Gian snimals © Deere si trol animals D. test animals ‘Choose the best answer A, B, C or D to complete the following sentences. ‘The-patient has a history .. - lyperizasion, mild heart palpitation, high adrenalin [ovals, and often san +, from insomnia, r iy ‘A. of suffer suffers C. aboutl acquire. about/ acquires Pau Choose the best answer A, B, Cor D to complete the following sentences. 40 act on the skin can be sneyamge 25 an intend / provided intend 04 fad. Seuneearele C. intension / conducted D. intending determined titeeded > de die Choose the best answer A, B, C or D to complete the following sentences. No wma symptoms were found in the low-and mid. cp Ta untavorabieB, unprofitable C. geeral inical answer A, B, C or D to complete the following sentences. pee ees eee ae animals sar howng similar symptons. i ly ifn Pease calanner (hate "nform/ others. D. infirm/the other canedtactls » agag lip he the following sentences. fat Me 5. cor Do complete een eapsule form at I'd like to say, Se een being ? pea He already 2 oe B. market /being D. marketed / being. ete the following sentences. Choose the bes answer A.B, Cor Smpanes tobe more rousparent ato hi. ‘An open day 2 is 'B. animals tested policy animals ee ‘animals testing policy Caren cerne fovig hes < O fag thass fhe foe cai ome ae ae prt fg teChoose the best stance Pest nereing aig ga * © complete faving sme 8Cy, andoprimal mee Ae igs “77 der to gather -- information abou the drug's safety. es > lft C.canyingon gen @hares 2 tate rats. Furthermore, it didn’t have any effect on blood presst i Ca Ts ele 0 pla ae i men J B- requirement. demanding necessities D. potential quality Choose the bet nsver AB Er comple the lowing snes. sar Onot + in blood pressure, peart palpitations, and ieaceeree s cee cies asc Choose the best an a wer A, Choose the best answer A, B, C or D to complete the following sentences In.comparisof’""........ the high-dose groups, animals in the low-dose and mid-dose groups showed no liege pena Atal ; i B.withtrials’ ——C.to/symptoms to trials Choose the best answer A, B, Cor D to complete the fllowing sentences Eisst, wo need to ‘hich enimal group isfeeziving lad concentration KHOC ‘Choose the best answer A, B, C or D to complete the following sentences. The results of pina testing are wed yf aumacetal methods how to determine best formulate the drug valtended clinical use ‘expe! their Bs pharmacist C pharmacists! ESO) ch Fie Choose the best answer A, B, Cor D ingseatnces. fd “of all testing must beCprovided ite Used Ses or er appropiate ulaon, on to egin clinical testing in hur agencies in other countries in order 0 eit ‘A. The findings / ask for y BIND Ae C.The outcomes / require Alfareconect 24 ¢ Choose the best answer A, B, C or D to complet the following sentences. Aw ian of changes ina study it a a Cheam changing . Comp ‘property be: ‘A,B, CorD to complete the following sentences. : Choose he san os conducted to crate ty eciveress of the dug in parila ication and to determine possible Fae Be ‘A, Phase [ Trials reacis th pase IL Tals, (6 ee5 ©. Phase Ill Trials / unwanted effeetsD. PHASEIV Trials 7 bene! “Choose the best answer A, B, C oF D to complete the following sentences, pericen vole (At2h Jing evidence that the drug is effective, these controlled and uncontrolled tials ~ obtain additional information to........-» the benpiietisk relationship of the dig. eee Salat ovale Cue ae eae Pei tte above/ coal Choose the best answer A, B, Cor D to complete the folowing sentences. — Regultory agencies review the one es and doumentaton ha arefequired in order fo proceed to next stage Of... ~ Respect /podstion B, typical /testings Particular / clinical trials GE! denclonment Choose th ees Choose the hes answer A,B, Cor D to amp thelowing sentences ome of her symptoms are KNOWN ne oF Mensamit: loss of sleep if taken in the late aftemoon or evening, increase in blood pressure, heart pelpitiiggsegnd headaches. (P1/53) ‘A. unwanted occurrence ide effects intended reactions D.ATMES corrst Choose the Bé@aliwer A, B, C or.D 10 compl Jr A, B, C orto complete the following sentenoes Seats Beate 6 Cesare eee) le GOREN? fd nag According te ED the safety and efficacy of a drug can only be .. ... by sondueting. clinic ials,. hia bal tags : Picea sees joe Bsa proved hard ae D. performed / severe Choose the best answer A, B, C orto complet the following senteoes On the whole, “ina trial must be willing to be randomly assigned to cither the group which receives the... sre medication or the one which gets a placebo. 'B matters approvable Sie! sco Bane : MERRIE ‘animals’ unapproving Choose the best answer A, B, C or D to complete the following sentences. Testing at preclinical stage of drug development can take from one to information about thesis of the drug, its safety, and ... Sema ees if ufactured. 5 ir Oh Thos B. pharmacy / what uc SE pharmacological / how D. pharmacology / what 1o complete the following sentences, Choose the best answer A,B; Coc} ve 7 oof lof test ily before the .. We have to ... {cach ste eer os ta ee ers a saa }. Explain / regulatory affairs * note / quality assurance ‘D, Interpret / research and developmentia DANG BAI CAU OI LIYA CHON {Choose the best answer A. Bc "pgs nfrmaton fae poe 2 COMI he allowing serene. 5 Tstory” ecg oT these PIL, ut also B. plete’ fmity Pye CHAE a gut SL comiec naietotcnanins ae B.Com tocompeethe flowy san if you are allergic to en A. sesame B, chovolare eam are not cones Choose the best answer A, B, C ot Dto complete 7 PA i eta lowing sentences, Use. int ™ vith caution wile .....,-n-« Orundenaking dangerous soos ving eatin od 8 B. eating, C. drinking D. sleeping best answer A, B, C or D to complete the following sentences, will we get permission to put the product i ou onthe art 'B. How soon inthe market low syon/ on the market 1D. How far! in the market Choose ba enster ABC a to. complete the following sentences, When ee eels . ‘Continues tofige) whan fessionals! patiy Choos@'ie best answer A Do not take Mensamine™ A. pulse. B. breath perature. high blood pressure Choose the best answer A, B, C or D to complete Sefollowing sentences. ‘You must not. ‘while taking Pogolox™, sports —Brsean alternative peas ey Dall re conet chose bes ansver A,B, Cor Di complete the flowing sentences ‘to complete the following sentences. ‘in future patent information leaflets. In terms about! improvements SH improvement D. In terms about improvement Chose te best ansuer A, By © orto complet the flowing seen sor at epee we on elon ea be egiscan Rta Si Ste aan cee r co eeepc acai best answer A Do not take Pogolox™ if yougae alletgte'té any .. : Av capes oo Grioznges pil means: : ane eyDeMarketing & Sales ‘A Administrton rear ee DM s 3 Choose the best answer A,B, C or D to co ena res sooo nk my a ‘has its offices and! called... ACS a eter ee an WEY oa SE er naepuertemal. Nu cgot DY] nen faes. ist tudy _D. Document fi 'B. Report . Research st Ou complete the following Sentences, ChooseTe best ances AB. or ofeg pment designed 1 perfom a pei faction. = ea ha RY Cpe. aml? Choo rt best answer A, B,C or Dto complete the following sentences, coe a elaine eae eat est answer A, B, C or D to complete the following sentencesEfficacy is the . ‘A. disability "77""7" O68 drug to.mreat the il ot which it was developed. ving ff small “2: Cor to complet tie following sonten Ghguas MMOs when added novo scale beans > ChocseThe Best answer a, 3, eens lsymup D. sssereoneseern 18 ig 10 complete the following sentences. : Requiem nson (sellkand distribute a new ie bs Choo Seg Tt authorization Papeete sesssce is ONeEA,B, C or D to complets the fallen Portes sine fod tess on dg li a f° B, Traine the best answer A, B, C or Di. complete a" whee porbetPate: Ham get Choos the betaeaver A, Bee folunteer 'D, Pharmacist Pogologt ney sesee AB, complete folowing seiences. iougliver damag B.lveed : a ee cane ei D liver seriousness damage wer A, B,C or D to compl 1c si % Inthe tablet predution procpmya facuun sytem sata Ee cei ys © Ce He eee Fbowder "C, pressed tablets D, dry ingrotients Choose the best answer A, BSC ort wer A, Bic orf to complete the fllowing sentences, es, TRG prdistion =e na 2 did baggie oe) fv liu es excess Cc Dray ingriems cote nt cptats gota, Boe In the tablet production proces, the aces msn i ‘A. granules B, excess powders bets Dr dry ingredients ‘Choose the best answer A,B, C or D to comple folio care Stop usa Fogolox"™ immediately i yon ee es ci st answer A, B, C or D to complete the following sentences, Like all antibiotics, Pogolox™ can cases wor. ) A. dizziness B. vomiting @Qiore fussche« 1D. loss of sleep Choose the best answer A, B, Cor D to complete tie following sentences. Please = corrosive Sistas, which could cause “C= eburns _B. palpitation . vomiting . Cho. ETE S Ce Dlee rece mierae cman palpation Tf you have a history of... ‘consult your doctor before taking meyay 'B. inflammation C. stroke Choose the best answer A, B, C or D to complete the following senten “The skulland-crossbones’ symbol is today generally used as a warning of danger, particularly in rege 0 substances B, comusive substances Tadioactive materials DD, raw substances Choose the best answer A, B, Cor D to complete the following sentences. ‘A closure must be pushed fore it can be unscrewed is called a. hoc ‘A. squeeze-crew ‘Choose the best answer A, B,C or D to complete Tinted inhi pg es ts D. Allare not correct idies 3 a Cor D to complete the following sentences. che answer A, B, C ie HP Sepa e eChoose the best ans, t bes answer A,B Cor Ys Oe: rose gore SPN a following eines PES ELE ne AIDA Deing/ uncomplicated Beane aa ‘ mune al be unconpeaon (Choose the best answ 5 =scoes = de Se answer A, B, C or D to complete the following sentences. ree beat eofmaing re tat secjreesand services ful s {cated the (hoe! gals assassin co eae * subsianeas”presoption lal ( — D, goods! GMP. Choose the bet answer A.B CS DE SSDS following sentences. ‘ust give very simple cler instructions that anyone can immediately under eer mae thatangone can jmmeitly ondersan Texeait MP is ona Further information! even if 1. Prescription! even pest answer A,B, CorD to complete the fllowing sentences. Pe a dicate {oj cli de _B.SideefTeet “indication : D. How to take ‘Choose the bes answer A, B, Gor D to complet te fallow lng sent In order 10 get eso drug a company has fo comnle dele documentation wih al he information oy ie. Fnae a hat reauite atrs B.SOPs rg evthorites D.Qa Chock the bem mngpec As, coer fo consis tie tollors seer Ch ag SPO reed no Rut RNS Mesa a rman an ne mean nai TES sy et egopecocennocael nue 'B plptaion/ unmask e nsomnial unmark D. hyperension! marked Sees Se ease cl lidedonges sscan be Was we have to enssre a Chee ‘Dcompltance press! all vices ERR proces a device D.SOP all devices ties Heine eo ermnae ne, senyences. : Tn the ae information, we will write in ‘which . Zt 7... the patients should definitely not use the and 1 warning abous taking i. dias, GO-= yeaa as tle bel, B. indication’ reports Pyorigns/ documertaions indication’ symptoms ‘Choose the ten answer A,B,C or wocomelste her son's death, the young. mother ¢ST> cof medicated patches: ‘A disposal-safe/ packenes . disposal-safe/ packaging ng sentences. Choose the best answerAs , Cor D to complete the following Sit rive PIL the géction the user about devs eds ation and is eal sine ofthe praductron. te" SS BalchA. Before you take ke Choose the best answer A, B, In the PIL, > C or D to complete the following sentences. {S the name of the section and categorizes unwanted, known side effects eee Ifeley ~ 2 if B. Uncommon side effect ‘ae D. Rare side effect, “I clioose the Best —— { i answer A, B, C or D to complete the foll c Dto 1 following sentences, In =, a She f QucLealets were eicked to $22 if the aferage maivon the set easily « Probability/ prescription B. readabilt readability cases sadability/ instructions i i oe . probabilty/ description Plone, tts best answer A, B, C or D to complete the following sentences, ase Temember, once you have gutsied the » it won't be possible to use the facilitie, ene Oka ‘toilet B. production area/ loos “packaging area/ WC D< hall area’ WC Choose the best answer A, B, Cor D tocpmplete the followi 5 eu ng sentences. Nowadays, RBP is a reseateb-drven, ee Pharmaceutical-enterprise that develops new drugs, produces them, prepares them for sale and lawides tongs 07 A. innovatively/ tells . innovative/ presents i Sq luo Choose the best answer A, B, C or D to complete the following sentences. ~. Our patients shouldn't be so alarmed that they afraid to actually put the ......c... in tir mouth axl wall , animal testing Both A and Bare correct e nthe blanks with missing c 4) Read the text and choose the answer A, B, € or D to fill i information. 2 Itis for this reason that animal testing is considered vital for improving human health and it is also why the scientific community and many members of the public support its use. In fact, there are also individuals who are against animal testing for cosmetics but still support animal testing for medicine and the development of new drugs for disease. nntists typically use animals for testing purposes because "they" are considered similar to humans. As such, researchers do recognise the limitations and differences but the testing is done on animals because they are thought to be the closest match and best one with regards to applying this data to humans. 1, Animal testing is considered........... for improving human health A. absolutely necessary B. important C. essential for improving human health D) All are correct 2 The scientific community and many members of the public support use of animal testing because iti B. absolutely necessary @ considered vital ery important D. None is correct correct 3. Although some individuals are against animal testing for cosmetics, they are still nimal testing for medicine and the development of new drugs for disease A. support (A) (B) in favour of (B) C. Neither A nor B is correct D. Both A and B are correct aragraph 2 refers to, 4, The word "they A. scientists animals C. testing purposes D, humans Sis _....the limitations and differences, researchers do the testing on animals. A. Although B, Though (O Despite D, Even though 5) Read the text and choose the answer A, B, C or D to fill in the blanks with missing information. Every year, millions of experimental animals are used all over the world. The pain, distress and death experienced by the animals during scientific experiments have been adebating issue for a long ti . long ti i ; ceatveniiery of. Se ee concem of ethics, there are few more consuming protocols an high cos n like requirement of skilled manpower, time femnati i f: eee eee ee robes ONS drawbacks a eee aera ageism procedures. A strategy of 3 ene Different oe at replacement) is being applied for laboratory use of Ee alternative organisms are applied to implement (his ee ee aren alternative means for the drug and chemical testing. ee scientific experiments suffer from the pain, distress and death experimental animals (A) B. animals (B) . Neither A nor B is correct. D. Both A and B are correct shave been a debating issue for a long time. ¢ pain, distress and death during scientific experiments scientific experiments ©) what experimental animals su All are correct 3. is the major concem of ethics. ‘A.The pain, distress and death experienced by the animals during scientific experiments (A) $B what experimental animals suffer during scientific experiments (B) (©)Both A and B are correct D. Either A or B is correct 4, There are .... cxamples of more disadvantages of animal experimentation. A. two three C. four D. five Various alternatives to animal testing were proposed experiments and avoid the unethical procedures. % to successfully deal with disadvantages (B) ‘A. to deal with difficulties (A) C Neither A nor B is correct associated with animal) D. Both A and are correct = fer during scientific experiments DANG BAI DOC HIEU (5 DOAN) 1)Read the text and choose the answer A, B, C or D to fill in the blanks with missing information. The primary. job responsibilities of Pharmacovigilance professionals are to provide ict/drug safety data and documentation. Pharmacovigilance professionals are qualified drug safety specialists. One particular area of their work includes performing & Jot of functional responsibilities like safety trend analysis, maintaining adverse reaction data, keeping global safety databases updated and conducting safety training. Pharmacovigilance is a pharmacological science that helps us to better evaluate the undesired effects of drugs, report "them" to the applicable authorities and thus help in ensuring that only safe drugs stay in the market. For that reason "it" is an extremely important job function. Pharmacovigilance professionals gather adverse drug reactionserse effect, healthcare providers and safety: datn froinipenple who hewn sipenienced amedverse.etley he like physicians as well as hospitals. CHATS professionals. L, Providing product/drug safety data and documentation are pre ‘A) main essential functions (A) B. job responsibilities (B) ©. Neither A nor B is correct D. Both A and B are correct 2. Pharmacovigilance professionals are........- A. drug Tyee , qualified drug safety specialists C. qualified specialists , specialists - wet 3. There are of Pharmac igilance..........examples of functional responsibilities performed by Pharmacovigilance professionals. i A. two B. three D, five 4. The word "them" in paragraph 2 refers to .. A. pharmacovigilance B, pharmacological scict e undesired effects of drugs D. the applicable authorities The word "it" in paragraph 2 refers to... A. pharmacovigilance (A) C. Neither A nor B is correct 2) Read the text and choose the answer information, Regulatory affairs specialists are expected to be extremely passionate regarding the safety and efficiency of drugs and medical devices in the health care industry. Their interest for the sector must be deeply grounded into their function, This role demands expertise in a few distinct areas to be able to become successful. Regulatory affairs specialists must have a wide understanding of legal, scientific and business concerns in order to perform their work effectively. "They" must ensure that products are developed within the legal framework and as per recommended guidelines. Regulatory affairs experts play a significant role in communication between their company and different regulatory bodies. Some of the assignments and projects they might be engaged in on a day-to-day basis include studying global regulations, gathering data regarding various products relevant to industry, preparing product labels and coming up with arguments for new drugs/medical devices licences. 1 There are passietiate. tremely passionate 0 B. three C. four D. five four B, pharmacological science (B) DBoth A and B are correct -B, Cor D to fill in the blanks with missing ..things that regulatory affairs specialists are expected to be 2. In order to perform their work effectively Regulatory affairs specialists must ...... Legal, scientific and business concerns. A. understand broadly understand C. widely understand well know’ 3, The word "They" in paragraph 2 refers to...‘A. Concerns D. Products s. Regulato n ry affairs ali: DiGhsine je Whee, 4.Regulatory affairs ex, sgulatere red Hi : company and terete = A. a significant role (A Ban i Chet A and B are Oe oe aie is D. None i - Studying global regulations is to-day basi: fone is correct sane one day-to-day bass. maa ee é assignments and projects (B) C. Both A and B are correct D. None is correct 3) Read the text and choose the answer A, B, Cor D to fill in the blanks with missing information. Each year the pharmaceutical landscape experiences changes stemming from regulations, technological innovation and discovery. With these changes arise new challenging variables for brand owners, packagers and original equipment manufacturers (OEM) to Overcome. We have seen a number of "ongoing" changes in the pharmaceutical industry that continue to take shape, including changes in pharmaceutical manufacturing and packaging standards. Por instance, manufacturers and their equipment suppliers are forging more partnerships for equipment validation. The adoption of a global regulatory track-and-trace and serialization system is gradually forming to combat counterfeit and gray market drugs. Research and development for packaging of complex biologicals and biosimilars is also continuing to evolve to meet the demands of a growing market. 1. Each year the pharmaceutical landscape. ........ changes stemming from regulations, technological innovation and discovery. .. in communication between their «++. Tegulatory affairs experts might be ‘A. undergo (A) B. encounter (B) Q Either A or B is correct D. Neither A nor B is correct ” ‘have to overcome new challenging variables caused by these changes. A. Brand owners B. Packages, C. Original equipment manufacturers (D}AI are correct 3. The word "ongoing" in paragraph lis the closest meaning to..... A. continuing (A) B. still in progress (B) C.Both A and B are correct D. Neither A nor B is correct ( In order to combat counterfeit and gray market drugs a global regulatory track-and- and serialization system is ... Pocceetialy(s) -—Cs«éR- ee adoption (B) eee ey caret D. Neither A nor B is correctjologicals and biosimilars is 5. Research and development for packaging of complex biologicals and bi also continuing to evolve to ..... .. of a growing market. = A. satisfy the needs (A) B. meet the demands ( ) . D. Neither A nor B is correct th :. Both A and B are correct 4) Read the text and choose the answer A, B, C or D to fill in the blanks with missing information. i e1 but Packaging material use for pharmaceutical products is not only for pase & ee also to indicate complete detail about the product. Unlike other products, there are norms and regulations for packaging and packing material use in pharmaceutical preparations. Three types of packaging (primary, secondary and tertiary packaging) are used to pack medicines and pharmaceutical products. "These" prevent products from destruction and prevent potency loss or degradation etc. Primary packaging is most important part of pharmaceutical material packaging. i Packaging used should be neutral and doesn't show any reaction or interaction with active ingredients or other ingredients of dosage form. Primary packaging should have many qualities to prevent dosage form during its self-life. "It" should be air locked and should prevent dosage form from any type of contamination. 1, Packaging material use for pharmaceutical products is for. two B. three C. four D. five 2. The word "These" in paragraph 1 refers to .... purposes. A. Pharmaceutical products B)Three types of packaging C. Medicines Pharmaceutical preparations .. is most important part of pharmaceutical material packaging. Primary packaging B. Secondary packaging ". Tertiary packaging D. All are correct 4. Packaging used A. should be neutral (A) B. doesn't show any reaction or interaction with active in, dosage form (B) ‘Both A and B are correct D. Either A or B is correct 5. The word "it" in the last sentence refers to ... A. important part reaction ¥ C. interaction Gus packaging SO UApwser A. gredients or other ingredients ofani 2. consumers for buying, It is ee and effective sales tool for encouraging the the basic functions such as aa ium" for sales promotion. It must perform all ete. and should not be decepti t be deceptive and convey any decepti “ti method for atiracting the consumers forbuying beeen Good packagir a ie - ea ae anes sie rode more easily and quickly as it works as a promotional eee el) it does self-advertising, displaying, publishing and acts as an aa eens jum. It is the package, size, design, color combinations and graphics that ‘ide its ability to attract the valuable attention of customers or the prospects. eiceres eis an important and effective sales tool for encouraging the consumers for buying. A. Packaging B. Designing and producing the container C. Designing and producing the wrapper D. Alll are correct 2. The word ee paragraph lis the closest meaning to... A. way method C. means D. All are correct 3. The word "“It" in paragraph 1 refers to A. Protection B, Storage ©) 4, Good packaging works as a promotional fool so it can... ell the product better ll the product more easily and quickly (B) C. sell the product easier and quicker (C) D.B and C are correct 5. According to paragraph 2 there are. .. _ things that decide its ability to attract the valuable attention of customers or the prospects. A. two B. three C. four (tive D. messageperticépatig faa qx earn thi DANG BAI CAU HOLLUA CHON Tay An 4 Choose the best answer A, Cor Dto complete the following sonences & Tomes! om artspntng spend sift )Partcinatng en Choos the bet answer A, C oD compete Orr blisne = toads cal Toney. nso gagonlion-ped exertion ae observedad docrsented lip th A.climination(4¥feabolis}0. exchange Deobseration @bSeaphion «Cap He Choose the best ansvgPASE=COFD 1 complet the followin cones, was the puls rate ineteasd, the blood pregage was bigh, A’Both/and DB. Neier ner |. Bither/or at only /butalso Choose the best ansver A, B, Cor D to copalae te filawing Ou gn ties shoved that he Shortage tempera hath unwanted effet onthe substance, (esis Breoont Coprevious De next 6 CChodstthe best answer A,B, Cor Dto complet the flowing sentences, T would like to zisl my healt si in clinical trials. subject "FB. topic C. theme D. Allare correct, Choos® the best answer A, B, C or D to complete the following sentences. Heavy drinkers ate more... than subess in clinical ils Avin risk B. on risks C. in risks Ose CChoose the best answer A, B,C oF D to complete the following senten Volunteers ... a big contribution... the field of medicine, no matter what their motivation is, ‘A take/ in B. have! in C. give! to ake/ to Choose the best answer A, B, C or D to complete the following sentences. “~~ 1 serious ill, vs efigitely take part ina clinical study. Iteould be my last hope! ‘A. was/ would B. am will ‘would DD. were/ wouldhave = W Jy fences, is the study of A. Pharmacy ities. Pharmaceutical a ‘or D to complete the following sentences. Spier nee Toxicity isthe study o risks tothe body nfiok J ‘A. impossible Potential C. possible D. potency Choose the bet nsw 8, Cs ia Bini aang Se a The patient reported not having. had anything to eat . {chocolate eandy bar four hours beforehand ‘Acand On: C.or D. except Choose the best answer A, Be@or D to complete the following sentences. Lasyenr, results of preclinical testing were used to come up with the best formulation of the onsen dru : |. OM Gintenies B. intending, C.intend. Duinends Uline; dv dh. Choos the best aiswer A,B, Cor Dt The general health and behayjag of fhe dogs)... rf ‘A. examined checked C. D. istested ‘Choose the best answer A, BYE or D to com Ik ™ to hurmans are determined in@oxisity studies) ‘A. Extensive documentation B 3 C- Intended drugs Or jal risks Choose the best answer A, B, C or D to complete hefollowing sentences. The anj ‘showed clinical symptoms were separated ...e:xee« More intensively, faiched _B. to-watch . watching . to watching nswet A, B, C or D to complete the following sentences. “ me a copy of your report on the clinical _as soon as possible?ete the following sentences. (on the type of drugs mad wailable, but also on how ig PDOs the best ansiver A, B, C oF D fo com very country establishes specific. they reach the customers, AL or) A. rule and regulation . principles and methods Choose the best answer A, B, C or D to complete the following ser In general, in the US, medication must meet four in order fo obtain the status of a non- presoriplign or over-the-counter product riteria a B. criterion C. media D. medium ‘Choose the best answer A, B, C or D to complete the following sentences, ach s,) ade hhould be done in other countries if we would like to sell this new drug in the! ional oy C. added D. plus c 2 Choose the best answer A, at or D to complete the following sentences. ‘The science of foisons, including their source, chemical composition, sction, test, and even their antidotes, is called ... mination B. contaminate Oren D tony 4, Choose the best answer A, B, C or D to complete the following sentences. * Our company already pas the to make tablets and pills. A. eine logy technician D. technical 44 ‘Choose the best answer A, B, C or D to complete the following sentences. Before drugs or medicines can be made ...:.mmmun t0 the ublic, they have fo be tested on human being. A. affordable B. capable C. acceptable pavailable clinical tr A. alternat 45 Choose the best answer A, B, Cor D to complete the following sentences. Chemists and pharmacologists are also interested in how the medicine is administered, so they often ask about formulationB. formula . form D. formation 4, Choose the best answer A, B, C or D to complete the following sentences. Rememeber that ing must be worn in the labs at al times, John. A. protect protective Yar C. protection D. protecting Me Kuo 1 Choose the best answer A, B, C or D to complete the following sentences. Development is the process of carrying scientific discoveries made during the research process, with the goal of producing a marketable drug. ; B. toward Pete Ov = tyte Ato Choose the best answer A, B, C or D to complete the follo ‘Manufacturing processes and procedures must go thro of an acceptable standard. A.control lidation (0 guarantee that they are still C. assurance 4 Da traceability 3 Choose the best answer A, B, C or D to complete the following sentences. The documentation required for all research processes and development drug. A. control B. validationyu quali» 4. Choose the best answer-A;B-C-or-Q to complete the following sentences. 7 A Gonsiders laboratoryand manufacturing processes and environment together and not A. control B. validation C. assurance © individually. © Choose the best answer A, B, C or D to complete the following sentences. L ee As some of you will already know, a new chemical, hhas just been synthesized in our own lal Acentry ), 1 B-entire ity qe” D- ensure nla ai ‘Dot dare & Choose the best angiver A, B, C or D to complete the following sentenged ©" ee ) agoure compliance with industry standards, (Qu goabjs to identify and correct any defects and ie ‘especially for laboratory procedures. usin A. preventive methods Cofuality system C. quantity problem a wir D. document failure {Choose the best answer A, B, C or D fo complete th sentences, i Although there were no’ serious instances 0 mpliance>a number of .. . of undesirable ‘conditions and practices were observed, VW/J/ 5 A. incidences B. accidents @ ws Prides id 5. Choose the best answer A, B, C or D to comalete the following sentences. Corrective Action / Preventive Action oy of the overall required for GMP. A. Good Practice ¢ Maui Management System C. Standard Operating Procedures Quality Assurance System Choose the best answer A, B, C or D to complete the following sentences. is observed during the audit, the department will be informed so they can take corrective Ifany action, A. non-obey B, non-efficacy Qdorsonrtanse D. non-control "© Choose the best answer A, B, C or, plete the following sentences. are updated on a reguldxbasisoften after an audit has been carried out. jood Practices B. Quality Management Systems dard Operating Procedures. Quality Assurance Systems “/. Choose the best answer A, B, C or D to complete the following sentences. strongly suggest that al sta the proper rules for hand-washing and sanitizing in future. ‘A. agree with mply vith, C. accep that D. understand yon ‘Choose the best answer A, B, C or D to complete the following sentences. ‘on all equipment following any experiments with laboratory animals. B. Infectant C. Virus-infected —D. Virus-infection