General Concepts In Pharmacology PDF
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This document provides an introduction to general concepts in pharmacology, including definitions, classification of medicines, drug discovery, development, regulation, history, and controversies. It covers various aspects of the field, potentially serving as a study guide or lecture notes.
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GENERAL CONCEPTS IN PHARMACOLOGY Definitions Classification Types of medicines CONTENTS Drug discovery Development Regulation History Controversies HISTORY DEFINITION SCIENCE THAT DEALS WITH DRUGS Regarding: SOURCE CHEMESTRY APPARANCE (FORMULATIONS) ACTIONS USE Any therap...
GENERAL CONCEPTS IN PHARMACOLOGY Definitions Classification Types of medicines CONTENTS Drug discovery Development Regulation History Controversies HISTORY DEFINITION SCIENCE THAT DEALS WITH DRUGS Regarding: SOURCE CHEMESTRY APPARANCE (FORMULATIONS) ACTIONS USE Any therapeutic agent Any substance other than FOOD DRUG Any substance used for: Diagnosis Alleviation Treatment or cure disease in man Legal TYPES OF MEDICINES Prescribed Over the counter Illicit DRUG DISCOVERY Most drugs derive from natural sources with a “therapeutic tradition” Biological engineering “Magic” to experience 1912 – Pure food and drug Act banned fraudulent therapeutic claims REGULATION 1938- Food, drug and cosmetics Act (FDA) prevention of marketing of untested drugs 1938 – FDA required a (NDA) New Drug Application before marketing was allowed 1962 – Efficacy (proof of effectiveness require Clinical testing IRB (institutional review board) Phases of clinical investigation Phase I Establish dose level where signs of toxicity first appears in 20-80 subjects ages 18 – 45 DEVELOPMENT Phase II Dose response in sick subjects Phase III Effective dose is known and efficacy is proven Followed by a new drug application Phase IV Post marketing studies CONTROVERSIES Price Accessibility
