---EXAM 1 REVIEW---- Monday, September 23, 2019 6:56 PM
Lecture 2:
Pharmacy is the science, art, and practice of preparing, preserving, compounding, and dispensing medicinal drugs and giving instructions for their use.
Early Research o Karl wilhelm scheele (1742-1786) 0 Friedrich Serturner (1783-1841) 0 Joseph Caventou 0 Joseph Pelletier
: USP & NF (1820)
Food and Drug Act (1906) o First federal law requiring strength, purity, and quality of drugs.
Sherley Amendment (1912) No false claims
Food, Drug, and Cosmetic Act (1938) Sulfanilamide - Diethylene glycol - 105 deaths o Required drugs be tested for safety o Tests to be submitted to FDA for approval based on Ingredients - Methods to evaluate products : Standards for formulations Preclinical studdies / clinical trials : Pharmacology - toxicology o Labeling directions 0 FDA can inspect facilities o NDA new drug application
Kefauver-Harris Amendments (1962) Thalidomide Drugs must prove safety and efficacy Drugs 1906-1938 excluded
Durham-Humphrey Amendment (1952) OTC vs RX onIy RX requirements
Comprehensive Drug Abuse Prevention and Control Act (1970) o 5 schedules of controls
FDA Pregnancy Categories (1979)
A, B, C, D, X groups Black Box Warnings
Drug Listing Act (1972) Manufacturers or repackagers FDA o NDC's
Drug Price Competition and Patient Terms Restoration Act (1984) ANDA- Abbreviated new drug application
Prescription Drug Marketing Act (1987) No importation or sales of drugs
Dietary Supplement Health & Education Act (1994) "Product not intended to diagnose, treat, cure, prevent any disease. o Influence on body structure and function ok
FDA Modernization Act (1997) o Labeling requirements o Recalls o Investigational treatments o Faster approval
Recalls Class 1- death or serious health consequences Class 2- temporary or reversible health consequence Class 3- no health consequences
Code of Ethics (AAPS) Conduct work in professional manner No scientific misconduct tolerated Respect differences in opinion Disclose external conflicts Report results honestly and accurately Respect ownership rights Do not discriminate race, gender, creed, nationality
Lecture 3:
: 1883 synthesis of antipyrine : Morphine from opium poppy .- Quinine from cinchona bark : Digitalis from foxglove . Belladonna from deadly night shade
"Goal Drug" o Produce desired effect o Most desirable route Minimal dosage and frequency Eliminated efficiently
: Pharmacology o Biologic activity, mechanism of drug in vivo & in vitro : Pharmacology & toxicology o Absorption, distribution, metabolism, elimination (ADME)
o Adverse effects, max dosage etc.
Early Formulation Studdies Done before animal studdies Drug solubility- - less than 10mg/ml is poorly soluble Partition coefficient: : Preference to lipid/aqueous phase o Dissolution rate- - Speed a drug dissolves Physical form- - Crystal vs. amorphous Stability
: CDER center for drug evaluation and research
IND investigational new drug application o Chemical structure o Animal testing o Plan for study o Manufacturing information
Phase 1 clinical trials Safety testing in 20-100 people Determine basic info on drug C CTM? : Biopharmaceutical properties : Practical considerations - Advantages of extemporaneous formulations o Short development time o Minimum drug substance required o Minimum formulation development o Minimal analytical work - Disadvanta