Microbiology & Parasitology LEC

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</xml></head><body>Remington 21st Edition.pdf <a
href=file:///C:/Users/admin/Documents/Physical Pharma LEC/Remington 21st
Edition.pdf>file:///C:/Users/admin/Documents/Physical Pharma LEC/Remington 21st
Edition.pdf</a> Normally, matter exists in one
of three states: solid, liquid,or gas Although it is not pharmaceutically important, twoother states of
matter exist: the plasma
state in which matterexists as a
hot gaseous cloud of atoms and electrons; and a morespeculative state, possibly
having only a momentary existence,is one which has characteristics of a
superdense supermetal transient
state is produced when material is sub-jected to very high pressures such as
those used to make dia-monds when compressing graphite. 1- Historical
Development of Pharmacy.pdf <a href=file:///C:/Users/admin/Downloads/1-
Historical Development of Pharmacy.pdf>file:///C:/Users/admin/Downloads/1-
Historical Development of Pharmacy.pdf</a> Greek Pharmakon”
 druggists practice in pharmacy safe and effective medication use. The bowl with a snake coiled around it 
Hygeia Aesculapius’s daughter bowl of Hygeia with the serpent of Epidaurus. Greek Goddess of health. symbol was a serpent drinking from a bowl
 wo snakes on a staff Caduceu staff epicted with
wings, Mercury (Roman
 Hermes (Greek pharmacy shop sign ools of traditional pharmacy, “recipe ‘take thou’) start of
prescriptions trial and
error folk knowledge
 SHANIDAR CAVE BURIAL Fait ne could avoid disease by leading a righteous lifeand worshipping the
proper God. 3 Deities/Gods
 Ninazu Ningishrida Gula 3 Main Medical
Practicioners: Asu 
Ashipu Baru sease is a
consequence of a SIN. LIBRARY OF
NINEVEH Asshurbanipal
 Ancient Egyptians estore harmony PAPYRUS EBERS pharmaceutical record collection GEORGE
EBERS libraryof
theUniversity medical papyri
ofAncient egy Pen-ts’ao
 Shen-nun material medica “fund am ental s of simples he botanical basis of pharmacy”. Greek medicine and pharmacy developed within this cultural
framework. Theophrastus
 father of botany." De Historia Plantarum and De causisplantarum
 Fall of Rome CLADIUS GALEN galenicals. prominentGreek physician for 1,50 0 
originator of the formula cold cream Three remedies HIERA
PICRA TERRA SIGILLATA
 was the pharmaceutical par
excellence antidote for poisons,
dysenteries, fevers and other illnesses. aloes spices
 other herbs oney argely herbal antidote to
the bites of wild creatures AVICENNA Canon
medicinae Rhazes (860-932) &
Avicenna separate practice of
pharmacy from medicine. id
13thcentury (1240) Frederick II codified Apothecary Renaissance Paracelsus quintessencesfrom ather
of toxicology PhilippusAureolusTheophrastus Bombastusvon Hohenheim Sparked the growth of modern Pharmaceutical
 DISCOVERY OF QUININE Quinine malarial fevers Germ
theory of disease Pasteur and
Koch 1880-189 1876 h
proved that microorganism cause disease Robert Koc DISCOVERY OF
VACCINE Pasteu 
ed 3 vacc fowl choler anthrax biowarfare agent<div>- also use in
asasination of important people back then.</div><div>- contagiuos thriugh
inhalation </div> rabies acute unflammation in the brain of human and
animals(rats, cats, and dogs).<div> </div> Emil Von Behring iphtheria was meant to cause light general
response when introduced.<div> </div> Paul Ehrlich’s Salvarsan 1910
 chemotherapeutic agents.
Antineoplastic drugs Salvarsan compound 606, magic bullet and
arsphenamine<div> </div> selective toxicity means killing the microbial cells
but not the
host's cellsMICROBIOLOGY_ASSIGNMENT_1.docx.pdf <a
href=file:///C:/Users/admin/Downloads/MICROBIOLOGY_ASSIGNMENT_1.docx.pdf>file:///C:
/Users/admin/Downloads/MICROBIOLOGY_ASSIGNMENT_1.docx.pdf</a> smallest unit of life is cell. xcept the viruses are composed of one or
manycell cell can be defined as a
basic fundamental unit of life first observed by a scientist named Robert Hooke 1665 unicellular organisms (single cell) acteria and archae prokaryotic cell multicellular organisms eukaryotic cells Both prokaryotic and eukaryotic cells 
cytoplasm cell membrane genetic
material in common before
 nut or kerne cell nucleus Prokaryotes without a
cell nucleus, membrane bound
organelles some prokaryotes are
multicellular. lue green algae
(cyanobacteria), bacteria archaea prokaryotic cells. acks
in mitochondria, endoplasmic reticulum, Golgi complex, lysosomes,
centrioles, simplest types of
cells he oldest form of life on
earth Bacteria, 
DNA ot contained within a nucleus. called nucleoid region Generalized structure of Prokaryotic cel receptor adhesive also provides protection to the cell wall genetic material (DNA) condensed into the small packet. transfers of DNA ell-cell adhesion ollow attachment present on the surface 
extension unfolded cytoplasm
 cellular respiration movement basal body rigidity and
support attachment to the
surface mating 
small hair-like structur storage rotein synthesis ayer of
protein and lipids, urrounds
cytoplasm egulate 
surviving during harsh conditions. 
Gram-positive Gram -negative bacteria rokaryotes large amount of peptidoglycan have the thin layer former atter
 advanced type of cells 
plant, animals, and fungi well-defined nucleus lgae, fungi, protozoa, plants, and animals and can be
single-celled,colonial or multicellular. general structure well-
defined nucleus DNA 
production of protein synthesis and ribosome
also chromosome 
surrounded by bi-lipid layer and controls the passage of ions and
molecules. ther organelles are
located metabolic activities of
the cell also take place owerhouse aking
ATP own DNA and ribosome
 algae and plant most important organelles in the plant 
converting energy sunlight into chemical
energy photosynthesis
 resembl cisternae stack of many flattened, disc-shaped sacs packaging of materials and in secreting them
 Lysosomes and Vacuole 
synthesis of Lysosomes digestion of intracellular molecules 
hydrolase. Vacuoles fluid as well as solid materials engulf materials through endocytosis transports lipids, proteins, and other materials
through the cell. T smooth
 rough Cilia are shorter than flagella and numerous
 movement Cilia and Flagella Glycocalyx olysaccharide utermost
layer of the cell ell
adherence protection and in
receiving signals from other cells. hapes, rigidity, and support cellulose, pectin, chitinor peptidoglycan. emi permeable surrounding the cytoplasm barrier entry and exit of
the substances inside and outside the ce two layers of phospholipids embedded with proteins Plant cell below Animal
 utermost protein synthesis Sedverg unit 80S ribosom upporting
framework of the cells two
types Microtubules and
Microfilaments. icrotubules
h protein called tubulin
 icrofilaments protein called actin Microtubules are the largest filament 
mucopeptide cellulose peptidoglycan absent ucleus
 'nucleoid presen nucleus enclosed within
nuclear membrane translation in
cytosol Transcription occurs in
nucleus together 
plasmid Reference-Standard Material
Qualification <a href=https://www.pharmtech.com/view/reference-standard-
material-qualification>https://www.pharmtech.com/view/reference-standard-material-
qualification</a> cientists performing
analytical testing use reference standards to determine quantitative (e.g., assay
and impurity) as well as qualitative (e.g., identification tests) data, performance
standards, and calibrators (e.g., melting point standards) 5 Common
Types of FDA Drug Applications: Quick Guide <a
href=https://www.nuventra.com/resources/blog/quick-guide-to-fda-drug-application-
types/>https://www.nuventra.com/resources/blog/quick-guide-to-fda-drug-application-
types/</a> The Investigational New Drug
(IND first category 
New Drug Application (NDA) second category launching point for clinical investigations in the United States
 primary purpose is to ensure, as much as possible, the safety and
rights of clinical trial participants. INDs may be categorized as either commercial or research 
Commercial INDs allow for the development of a
drug or biologic with the goal of ultimately submitting a marketing
application Research INDs involve
therapies that are not intended for commercialization but are being investigated
strictly for research purposes emergency INDs treatment
of immediately life-threatening conditions when no standard acceptable treatment is
available and insufficient time exists to receive Investigational Review Board
(IRB) all IND applications must
include information about the quality and nonclinical safety of the investigational
product as well as the proposed clinical protocol and investigator. 
a formal request made by a Sponsor to market a
new drug in the United States goals of the NDA rovide
enough evidence to support the safety and effectiveness of the drug and to show
that the benefits of its use outweigh the risks he NDA is much more comprehensive than the IND
 body’s effect on the drug 
drug’s effect on the body eview and approval of a generic drug product.
 not required to include pre-clinical
(animal) and clinical (human) data to establish safety and effectiveness
ansels-pharmaceutical-dosage-forms-and-drug-delivery-systems-10th-
ed.pdf <a href=file:///C:/Users/admin/Downloads/ansels-pharmaceutical-
dosage-forms-and-drug-delivery-systems-10th-
ed.pdf>file:///C:/Users/admin/Downloads/ansels-pharmaceutical-dosage-forms-and-
drug-delivery-systems-10th-ed.pdf</a> n 1821,
the Philadelphia College of Pharmacy was established as the nation's
first school of pharmacy. 820,
the United States Pharmacopeia (USP) was created to aid in establishing
standards for drugs in the United States. pharmacopeia pharmakon any recipe or
formula or other stan-dards required to make or prepare a drug.
 first American pharmaco-peia was the
so-called Lititz Pharmacopeia, The first American pharmaco-peia was the so-called Lititz
Pharmacopeia, published in 1778 at Lititz, Pennsylvania, for use by the Military
Hospital of the United States Army. It was a 32-page booklet con-taining
information on 84 internal and 16 external drugs and preparations.
 ast decade of the 18th cen-
tury, 1808 Massachusetts Medical Society published a 272-
page pharmacopeia January 6,
1817, Lyman Spalding creation
of a national pharmacopeia. recognized as the Father of the United States
Pharmacopeia. four geographic
districts—northern, middle, southern, and western. Each district's convention was to draft a
pharmacopeia four district
pharmacopeias were to be compiled into a single national
pharmacopeia January 1,
1820 The first USP was pub-
lished on December 15, 1820 English and Latin, then the international language of medicine, to render
the book more intel-ligible to physicians and pharmacists of any
nationality. he objective of the
first USP was stated in i the
convention adopted a constitution and bylaws, with provisions for subsequent
meetings of the convention lead-ing to a revised USP every 10 years. 
1900 the Pharmacopeial Convention granted authority to issue sup-
plements to the USP whenever necessary to maintain satisfactory
standards. 940 meeting of the
convention, it was decided to revise the USP every 5 years while maintain-ing the
use of periodic supplements. he
first United States Pharmacopeial Convention was composed exclusively
of physicians. In 1830 and again
in 1840, promi-nent pharmacists were invited to assist in the revision,
 in recognition of their contribu-tions
pharmacists were awarded full mem-bership in the convention of 1850
 By 1870, the USP was so nearly in the
hands of phar-macists that vigorous efforts were required to revive interest
in it among physicians. Of the
eight elected members of the board of trustees, at least two must be
representatives of the medical sci-ences, two others must be representatives of
the pharmaceutical sciences, one must be a public member, and three shall
serve without restriction concerning their affiliation. The USP of 1820 reflected the fact that the
apothecary of that day was competent at collecting and identifying botanical
drugs and preparing from them the mixtures and preparations required by
the physician. The second
half of the 19th century brought great and far-reaching changes.
 ndustrial revolution was in full swing in
the United States. The steam
engine, which used water power to turn mills that powdered crude botanical
drugs, was replaced by the gas, diesel, or electric motor New machinery was substituted for the old whenever
pos-sible, and often machinery from other indus-tries was adapted to the
special needs of pharmaceutical manufacturing. Mixers from the baking
industry, centrifugal machines from the laundry industry, and sugarcoat-ing
pans from the candy industry were a By 1880 the
industrial manufacture of chemicals and pharmaceutical products had
become well established in this country, solation of some active constituents of plant
drugs led to the knowl-edge of their chemical structure. 
872 synthesis of salicylic acid from phenol inaugu-rated the synthesis of a
group of analgesic com-pounds including acetylsalicylic acid (aspirin)
 which was introduced into medicine
in 1899 Among other chemicals
synthesized
for the first time were sleep-producing derivatives of barbituric acid
called barbiturates. synthetic
organic chemis-try—welcomed the turn into the 20th century maladies
disorder<div> </div> 1910 arsphenamine, a
specific agent against syphilis, was introduced to medical science
 the start of an era of
chemotherapy Paul Ehrlich, the
German bacteriolo-gist who together with a Japanese colleague, Sahachiro Hata,
discovered arsphenamine. The
standards advanced by the USP were more than ever needed to protect the
public by ensuring the purity and uniformity of drugs.0002035880.INDD
1011/29/2013 3:16:57 PM When
the American Pharmaceutical Asso-ciation (APhA) was organized in 1852, the only
authoritative and recognized book of drug standards available was the
third revision of the USP Because of strict selectivity, many drugs and formulas that were accepted
and used by the medical profession were not granted admis-sion to early revisions
of the USP in keeping with the
original objec-tives of the APhA to standardize drugs and formulas,
certain pharmacists, with the sanc-tion of their national organization,
prepared a formulary containing many of the popular drugs and formulas
denied admission to the USP. 888 under the title National Formulary of Unofficial Preparations
(3) The title was changed to
National Formulary (NF) on June 30, 1906 President Theodore Roosevelt signed into law the first federal Pure Food and Drug
Act, designating both the USP and NF as establishing legal standards for medicinal
and pharmaceutical substances. Thus the two pub-lications became official compendia. 
he early editions of the NF served mainly as a
convenience to practicing pharmacists by providing uniform names of drugs
and preparations and working directions for the small-scale
manufacture of popular pharmaceutical preparations prescribed by
physicians. efore 1940, the NF,
like the USP, was revised every 10 years. After that date, new editions appeared every 5
years, 1975, the United States
Pharmacopeial Convention, Inc. purchased the NF Today, the United States Pharmacopeia-National
Formulary (USP-NF) is continuously revised Revisions are available annually in hard copy and as online
editions, includ-ing twice-yearly supplements and update notices on the USP
Web site. Monographs for drug
substances, dietary supplements, dos-age forms, and compounded preparations
are contained in the USP sections of the com-bined compendium whereas
monographs for pharmaceutical excipients are contained in the NF
section. 2006 Presently, USP standards are used in more than 140
countries worldwide ensuring the
availability of quality drugs and pharmaceutical products and
preparations. products” is now
generally used to refer to manufactured drugs and “prepa-rations” to
compounded drugs. he USP-NF is
used by pharmacists, physicians, dentists, veterinarians, nurses, producers, and
sup-pliers of bulk chemicals for use in drug pro-duction; large and small
manufacturers of pharmaceutical products; drug procurement officers of various
private and public health agencies and institutions; drug regulatory and
enforcement agencies; and others The USP and NF adopt standards for drug substances,
pharmaceutical ingredients, and dosage forms reflecting the best in the
cur-rent practices of medicine and pharmacy and provide suitable tests and
assay procedures for demonstrating compliance with these standards. In
fulfilling this function, the com-pendia become legal documents, every state-ment
of which must be of a high degree of clarity and specificity
 a drug with a name recognized in the
USP-NF must comply with compendial identity standards or be deemed adulterated,
misbranded, or both. o avoid
being deemed adulterated, rugs
recognized in the USP-NF also must comply with compendial stan-dards for
packaging and labeling. he initial
part of the monograph consists of the official title (generic or nonproprietary
name) of the drug substance. This is followed by its graphic or structural
formula, empiri-cal formula, molecular weight, established chemical names,
and the drug's Chemical Abstracts Service (CAS) registry number.
 Appearing next in the monograph is a
statement of chemical purity, a cautionary statement that reflects the toxic
nature of the agent, packaging and storage recommendations, and chemical and
physical tests, and the prescribed method of assay to substantiate the
identification and purity of the chemical. PUS is used by pharmacists and homeopathists as
well as by law enforce-ment agencies that must ensure the quality of
homeopathic drugs. The term homeopa-thy was coined by Samuel
Hahnemann (1755–1843) from the Greek homoios, mean-ing similar, and
pathos, meaning disease. In essence, the basis of homeopathy is the law
of similars, or that like cures like: that is, a drug that produces
symptoms of the illness in healthy persons will also be capable of
treating those same symptoms and curing the disease. The IP is published by the World Health
Organization (WHO) Prescription
drugs must bear the symbol “Rx Only” New drug substances are limited to prescription-only 
Durham-Humphrey Amendment of the Federal
Food Drug and Cosmetic Act estab-lished a legal distinction between
prescription and over-the-counter (OTC) or nonprescrip-tion drugs. Until that
time, all drugs could be purchased over the counter by consumers. 
Kefauver-Harris Amendments to the Federal Food
Drug and Cosmetic Act of 1938. thalidomide, OTC in
Europe. apparent lack of
toxicity even at extreme dosage levels. investigational new drug application (IND)
 NDA seeking approval for marketing
 Phase 1 includes the initial
introduction of an investigational drug into humans and is primarily for
the purpose of assessing safety. he initial dose of the drug is usually low, usually one tenth
of the highest no-effect dose observed during the animal studies.
 Phase 1 studies are designed to determine
the human pharmacology of the drug, struc-ture–activity relationships, side
effects asso-ciated with increasing doses, and, if possible, early evidence of
effectiveness. Only clinicians
expert in the disease being treated are used as investigators during Phase 2
studies Phase 2 trials are
controlled clinical stud-ies to evaluate the effectiveness of a drug in
patients with the condition for which the drug is intended and to assess side
effects and risks that may be revealed. Because this phase uses patients as
subjects, side effects or toxicity symptoms that were not shown in the
preclin-ical animal studies or in Phase 1 studies with healthy volunteers may be
revealed for the first time hase 3 studies may include several hun-dred to several thousand
patients in con-trolled and uncontrolled trials. Dioscorea Hormonal substances, such as thyroid extract, insulin, and
pituitary hormone obtained from the endocrine glands of cattle, sheep, and
swine, are lifesaving drugs used daily as replace-ment therapy in the human
body. The urine of pregnant
mares is a rich source of estro-gens. Today the poliomyelitis vaccine is prepared in cultures of renal mon-
key tissue, the mumps and influenza vac-cines in fluids of chick embryo,
the rubella (German measles) vaccine in duck embryo, and the smallpox
vaccine from the skin of bovine calves inoculated with vaccinia virus.
 Chapter 2 • New Drug DevelopmeNt
aNDapproval proCess39be chemically modified to yield important drugs with
profound pharmacologic activity. For example, the various species of
Dioscorea, popularly known as Mexican yams, are rich in the chemical
steroid structure from which cortisone and estrogens are semisynthetically
produced.Animals have served humans in their search for drugs in a
number of ways. They not only have yielded to drug testing and biologic
assay but also have provided drugs that are mannered from their tissues
or through their biologic processes. Hormonal substances, such as thyroid
extract, insulin, and pituitary hormone obtained from the endocrine glands
of cattle, sheep, and swine, are lifesaving drugs used daily as replace-ment
therapy in the human body. The urine of pregnant mares is a rich source of
estro-gens. Knowledge of the structural architec-ture of the individual
hormonal substances has produced a variety of synthetic and semi-synthetic
compounds with hormone-like activity. The synthetic chemicals used as oral
contraceptives are notable examples.The use of animals in the production of
various biologic products, including serums, antitoxins, and vaccines, has had
lifesaving significance ever since the pioneering work of Edward Jenner
on the smallpox vaccine in England in 1796. Today the poliomyelitis
vaccine is prepared in cultures of renal mon-key tissue, the mumps and
influenza vac-cines in fluids of chick embryo, the rubella (German
measles) vaccine in duck embryo, and the smallpox vaccine from the skin
of bovine calves inoculated with vaccinia virus. New vaccines for diseases such as
AIDS and cancer are being developed through the use of cell and tissue
cultures Both recombinant rDNA
and mAb production techniques influence cells’ ability to produce proteins
 recombinant DNA mAb production is conducted entirely within the cells
of higher animals, including the patient. The technique exploits the ability of
cells with the potential to produce a desired antibody and stimulates an unending
stream of pure antibody pro-duction. These antibodies have the capacity
to combat the specific target. The
first human gene therapy used was to treat adenosine deaminase (ADA)
defi-ciency, a condition that results in abnormal functioning of the immune
system. Therapy consisted of the administration of geneti-cally modified
cells capable of producing ADA Human gene therapy c Pacific yew tre
Week1_IntroductiontoMicrobiolody.pdf <a
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MitYtEDfTjxAqeyTxzt>https://www.weavatools.com/apis/pdfstorage/-
MitYtEDfTjxAqeyTxzt</a> The study of
microscopic organisms Bacteria Viruses,
 Fungi Protozoa </body>

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