University:
University of Virginia
Course:
NUIP 2430 | Pharmacology and Clinical Management I
Academic year:

2024
Views:

143

Pages:

3
Author:

Zoe C.

‭Randomized Controlled Trial (RCTs)‬ ‭●‬ ‭Subjects are given the new drug, and controls are given either:‬ ‭○‬ ‭Standard treatment‬ ‭○‬ ‭A placebo (inactive compound)‬ ‭●‬ ‭Subjects are randomly assigned to either the control or experimental group‬ ‭○‬ ‭Prevents allocation bias‬ ‭●‬ ‭Blinded study: People involved do not know to which group subjects are assigned‬ ‭○‬ ‭Single blind: Only the subjects are blinded‬ ‭○‬ ‭Double blind: The researchers and subjects are both blinded‬ ‭Stages of New Drug Development‬ ‭Limited Information on Women and Children‬ ‭●‬ ‭Little drug testing was done on women of childbearing age before 2000‬ ‭●‬ ‭In the late 1990s, the FDA issued guidelines mandating the participation of women and‬ ‭minorities in trials of new drugs‬ ‭●‬ ‭Until recently, women were excluded from clinical trials, and knowledge has often been‬ ‭derived from postmarketing surveillance‬ ‭Failure to Detect all Adverse Effects‬ ‭●‬ ‭During trials, a relatively small number of patients are given the drug‬ ‭●‬ ‭Since patients are carefully selected, they do not represent the full spectrum of‬ ‭individuals who will eventually take the drug‬ ‭●‬ ‭Patients in trials take the drug for a relatively short period of time‬ ‭Three Types of Drug Names‬ ‭Chemical Name‬ ‭●‬ ‭Constitutes a description of the drug using the nomenclature of chemistry‬ ‭Generic/Nonproprietary Name‬ ‭●‬ ‭Each drug only has one generic name‬ ‭●‬ ‭The final syllables‬‭often‬‭indicate a drug’s pharmacologic‬‭class‬ ‭Brand/Proprietary/Trade Name‬ ‭●‬ ‭Names under which a drug is marketed‬ ‭●‬ ‭Meant to be easy to recall and pronounce‬ ‭●‬ ‭A single drug can have many brand names, as it can be marketed in‬‭different‬ ‭formulations‬‭and by different companies‬ ‭Generic vs. Brand Name Products‬ ‭●‬ ‭All equivalent products contain the‬‭same dose‬‭of the‬‭same drug‬ ‭●‬ ‭The concern with generic formulations is their‬‭rate‬‭and extent of absorption‬ ‭Over-the-Counter (OTC) Drugs‬ ‭●‬ ‭Drugs that can be purchased without a prescription‬ ‭●‬ ‭Account for 60% of all medications administered‬ ‭●‬ ‭Labels have been made standardized, informative, and easy to understand‬