The document discusses the process of developing and approving new drugs. It explains that new drugs are discovered through natural products, laboratory synthesis, or high-throughput screening. Drugs then undergo preclinical testing in animals and cells to determine safety and effects before human trials. The clinical trial process involves 4 phases to evaluate a drug's safety, efficacy, and optimal dosage in humans. Finally, the FDA approves drugs that demonstrate sufficient benefits outweighing risks based on all trial data and intended use.
The document discusses the process of developing and approving new drugs. It explains that new drugs are discovered through natural products, laboratory synthesis, or high-throughput screening. Drugs then undergo preclinical testing in animals and cells to determine safety and effects before human trials. The clinical trial process involves 4 phases to evaluate a drug's safety, efficacy, and optimal dosage in humans. Finally, the FDA approves drugs that demonstrate sufficient benefits outweighing risks based on all trial data and intended use.
The document discusses the process of developing and approving new drugs. It explains that new drugs are discovered through natural products, laboratory synthesis, or high-throughput screening. Drugs then undergo preclinical testing in animals and cells to determine safety and effects before human trials. The clinical trial process involves 4 phases to evaluate a drug's safety, efficacy, and optimal dosage in humans. Finally, the FDA approves drugs that demonstrate sufficient benefits outweighing risks based on all trial data and intended use.
○ Antihypertensives - lower bp ● All diseases have a molecular basis [pathogenic ○ Antidysrhythmics/antiarrhythmics treat an abnormal /genetic] heartbeat ● Biochemistry regulating cells, organs, metab processes ○ Antipsychotics, antidepressants, anticonvulsants, ● Understanding a bacterium’s biochemical processes → antinauseants develop a strategy to attack/impair its function = kill ○ Decongestants, hallucinogens, sedatives, stimulants cells ⬥ Pharmacological classification - mechanism of action on ○ Inhibition - introduce a molecule that binds to active the molecular level; the WAY drug achieves change site of an enzyme = kill ○ Calcium channel blockers - block ca channels in the ○ Regulate signalling molecules heart and limit passage of ca ions thru the cell ○ Other biochemical function membrane ● Identifying the exact cause = develop a molecule to be ○ Angiotensin-converting enzyme inhibitors (ACE) - introduced to the body to regulate such discourage the formation of angiotensin II by inhibiting the enzyme responsible for its production activities/mechanisms from angiotensin DRUGS ○ Beta-adrenergic blockers inhibit proteins that receive — a molecule of this nature will have a highly specific epinephrine [adrenaline] → heartbeat slower, BP is therapeutic effect lowered — a chemically acting substances which has a ● way a drug interacts with a biomolecule, usually a physiological effect when introduced to the body, other protein (enzyme/receptor) that modifies the activity of than food (subs w nutri value), whether w therapeutic that protein making it more specific. Biochem is req to effect or not make sense of it — mole used strategically to cure illness ● Classification depends on context, what’s being - Natural products — may exit in nature animal, examined, described in a moment + the efficacy of a plants, or microorg particular drug kung ano man mas - Synthesize in a laboratory appropriate/commonly used - Biomacromolecule/biologics - large macromolecule Naming Drugs like antibody 1. Chemical name - determined by the rules of chemical nomenclature PHARMACOLOGY designated by the IUPAC Intl Union of Pure and ● Know what they do in the body to its molecular level, Applied chemistry applications, safety - Only one chemical name ● Branch of med that is concerned with the uses, effects, - Specific rules, one molecule = one name [even if and mechanisms of action for any and all drugs super long] - Chem → small molecules, biochem → biomolecules - Chemically sounding → “chemophobia” - like protein/nucleic acids irrational fear of chemicals/sounding things - Biology → Cell structure, activity bc drugs may 2. Generic Name affect cell division, metabolism, or any number of - assigned by the U.S. Adopted Name Council for other complex cellular processes. short and easy drug names - Only one generic name → nonchemists can - Anaphy → structure n function of all components of pronounce and understand these. h body [n its systems ]bc disease affect their regular 3. Brand/Trade name function + drugs have to travel thru the body to - Any number of brand names reach a particular target = response - Chosen name is more for marketing - Microbiology → pathogens/disease causing - Identical to active ingredient of generic microorganisms - Pharma companies wanna make a bias in ● With enough bg knowledge → comprehend the effects consumer trends towards their version of the a drug will have in the body, and the various factors that generic influence a drug’s bioactivity. Combination Drugs ● This also means we won’t fall for any medicine-related - Drugs with more than one active ingredient Generic name vs. Brand name hoaxes ● 100% same active ingredient Categorizing Drugs: Classes, Names, and ● Bioavailability differs bc of discrepancy in inactive Schedules ingredients - ability of the drug to move through the Classification body to reach its target and elicit the desired effect. ⬥ Therapeutic - CLINICAL purpose of the drug; Discrepancies are minimal or completely negligible physiological change induced by the drug; Scheduled drugs {Drug Abuse/Addiction} ○ Anticoagulants - help prevent blood clots ● Physical/psychological dependency ● Classified accdg to the degree of potential for abuse ○ I - highest abuse potential, no accepted med use: - All trial data, intervention for intended use, heroin [most addictive substance known], marijuana, benefits> risks LSD - Once approved = SECOND TRANSLATIONAL ○ II - high ab pot w severe dependence; narcotics, MOMENT it’s ready for pts → intervention is not a amphetamines, and barbiturates; morphine and science exp cocaine Monitoring → ensures tx remains safe and effective ○ III - less ab pot than ^ mod dep liability; onbarbi- turate sedatives, nonamphetamine stimulants, limited How Does the FDA Approve a Drug? amounts of certain narcotics; ketamine, anabolic ● Drugs need a target [cancer cells viruses enzymes or steroid, low lvls of codeine receptors on the surface of our own cells] ○ IV -limited dependence liability (some sedatives, ● new drugs can be discovered in any number of ways antianxiety agents, and nonnarcotic analgesics ● Derived from natural products, or created in a Valium and Xanax laboratory to have a specific chemical structures to fit a ○ V - limited abuse potential; antitussives, diarrheals, given target [de novo drug design] small amt of narcotics (codeine) cough medicine and ● High-throughput screening or HTS → utilizes robotics other OTC [low dependency] and high speed computers to evaluate huge numbers of ● Greater abuse = less thera application potential drug molecules quickly and efficiently if a Other are not included in the triangle: caffeine, alcohol compound is found to be active for a given target it may be considered for further investigation FDA ● Potential drug compounds undergo studies to assess Step 1: Discovery and development how it is absorbed, where it is distributed, how/where ● Findings on dse process ← how can we stop or reverse it’s metabolized, excreted [PHARMACOKINETICS] effects of dse ○ Important est safety/appropriate dose for human ● Molecular compound tests to find effects trials ● Preclinical studies animals? The Clinical Trial Journey ● investigational new drug or IND application must be ● How a medical intervention such as a drug, device, or filed with the FDA procedure moves from an idea into patient care. PHASE 1 1. DISCOVERY SCIENCE ● Safety of the drug, pharmacokinetic profile + side - In the lab researchers use computer, cells and effects animal models to answer basic questions, like ● Dose escalation to est highest tolerated dose "How does DNA work?" and "How do cells talk to ● 20-100 healthy volunteers each other?" PHASE 2 ● Candidate is tested to est safety AND EFFICACY of the 2. FIRST TRANSLATIONAL MOMENT. compound - translated into clinical research ● 100-600 volunteers w disease state 3. PHASE 1 CLINICAL TRIAL ● Still pharmacokinetics but more interested if the drug - looking for answers with the help of volunteers. hast the effect we want on the disease + symptom Here, researchers answer questions about safety, optimal dose for sick patients and how well participants tolerate the medical PHASE 3 intervention. ● Same as phase 2 but 1000s of volunteers w disease - These trials don't include many volunteers and state all over the world they are short, usually only a few months long. ● Key in est in labelling data that will accompany the drug 4. PHASE 2 CLINICAL TRIAL After that - "Is what I'm studying effective for patients with ● New drug app to FDA, does not guarantee approval, this health condition? Any side effects? How does ”approvable letter” (aadjust), denied it compare to a placebo?" Post market surveillance - usually done with a medium-sized group of ● monitored and pharmaceutical companies often submit volunteers. long-term safety data to FDA - The studies can last for several months-years ● Phase 4 - medwatch program - Common to end → no funding disappears, results
inconclusive, int fails 5. PHASE 3 CLINICAL TRIALS Brand Name Medications and Generics - set out to confirm the results of previous trials in ● before a company can manufacture and market a a larger study. generic drug in the United States it must submit an - how does it compare to other treatments? How abbreviated new drug application or a NDA to the FDA effective is it with a lot more people? ● This application includes data providing the generic - Need years to complete product is both FDA Reviews ○ pharmaceutically equivalents means that the generic drug contains the same drug compound as the innovator drug as well as having the same strength ○ Throw in trash same route of administration and same dosage form ○ Scratch out prescription label ○ bioequivalence the generic product must have the ● Don’t give unwanted meds to friends same effect as the brand drug meaning that the The 5 Rights of Medication Administration compound has same action in the body, in the same I. Right Drug amt of time - Read label on vial/bottle/packet before you give ● Excipients - inactive ingredients in a drug product meds [magkaiba sa generic n branded depending on II. Right Patient manufacturing processes] - Ask for medical identifiers name and bday ○ Compound to bulk up tablets - lactose, starch, III. Right Dose microcrystalline cellulose - Appropriate for the med and pt ○ Other excipients can help tablets disintegrate, IV. Right Route provide flavoring and coloring V. Right Time ● narrow therapeutic index ● Right documentation → side/adverse effects ○ drug is only effective within a very small dosage ● Appropriate assessment range too little = no effect, too much = harm ● Evaluation → how pt is responding to the med ● Be cautious in switching branded to generic of certain ● Pt’s right to education NTI ● Pt’s right to refusal ● chemical compound is a chemical compound ○ Informed consent, understands med what and why and as long as bioequivalence is assured brand and generic drugs should give the same results there may be good reason to HOW 2 RMBR DRUG NAMES EASILY -afil PDE type V vasodilation 9 Ways to Medication Safety inhibitors 1. Know the name & purpose of your meds -azepine Dibenzazepines Na channel bloc → 2. Keep a list of your meds antiepileptic agents 3. Know how to take meds: follow drug label -azole Antifungal Imidazole / triazole Know when your last inj was given, how often you are given; inform dr/nurse at every visit -azosin A1 blockers Direct vasodilators 4. Don’t take more or less of your medications than prescribed -bendazol Benzimidazole Antihelminthic 5. Don’t crush or break your meds [unless instructed] e 6. Know where to store your meds → don’t store under -caine Local anesthetics esters/amides sunlight and heat; moisture; keep in cool and dry place, out of reach of children -capone COMT inhibitors 7. Don’t use expired medications → dispose or bring to -cillin Penicillins Gm + and few gm- pharmacy 8. Don’t use someone else’s -cycline Tetracyclines Antibacterials (inhibit 9. Keep your doctor/pharmacist informed if u have protein synthesis) ● Allergies -dipine Dihydropyridine CaChannelBs that act ● Side effects directly on smooth muscle ● Stopped your medication or if it looks diff in any way -floxacin Fluoroquinolones Inhibit bacterial topoisomerase / DNA repli Safe Medication Disposal -formin Biguanides Reduces hepatic ● Read labels, take them accdgly, store in safe place outta gluconeogenesis reach of children, keep out of the hands of those who -giline MAO B inhibitors Inh metab of dopamine in might abuse them CNS (parkinson) ● Safely dispose expired/damaged/no longer wanted meds -glinide Non-sulfonylureas ○ Don’t get meds more than you need ● Check label and packaging first for special instructions -gliptin DPP IV inhibitors Inhib metab of incretins like GLP; inc insulin release [flush] ● Dispose in take-back program/ pharma -glitazone PPAR gamma Act on nuclear receptors → ● Throw them in the trash at home inhibitors affect hepatic glucose ○ Remove meds from original packaging and mix w turnover: antiDM something undesirable → less appealing -gravir Integrase inhibitors Inhibit merging of viral DNA ○ Seal the mixture in a bag, can or other container to w host DNA prevent leakage