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FDA
Clinical Studies
Generic Drug Development
Miscellaneous
100
Federal agency that is required by law to review and approve all new drugs in the US
What is FDA
100
Typically involves 20-80 healthy volunteers (no women of childbearing potential)
What is Phase 1
100
Form submitted to the FDA for approval of a generic drug products
What is Abbreviated New Drug Application (ANDA)
100
Studies in humans can only begin after IND is reviewed and approved by
What is FDA and an Institutional Review Board (IRB)
200
Passed after a legally marketed toxic elixir killed 107 people, including many children
What is Federal Food, Drug, and Cosmetic Act
200
Emphasis is on safety and effectiveness
What is Phase 3
200
Rate and extent of drug availability at the site of action are about the same
What is Bioequivalent
200
Absorption, distribution, metabolism, excretion, half-life
What is Pharmacokinetics
300
Responsible for prescription and over-the-counter (OTC) drug safety and efficacy
What is Center for Drug Evaluation and Research (CDER)
300
About 33% of drugs will pass this phase
What is Phase 2
300
Product provides a significant improvement to marketed products
What is Priority Review
300
Prototype chemical compound that has a fundamental desired biologic or pharmacologic activity
What is Lead Compound
400
Regulates products such as vaccines, blood, and gene therapy
What is Center for Biologics Evaluation and Research
400
Post-market surveillance of the drug to continually assess the safety of the drug
What is Phase 4
400
Provides information on approved drug products with therapeutic equivalence evaluation
What is Orange Book
400
Mechanism of action and estimates of therapeutic effects
What is Pharmacodynamics
500
Regulates most foods
What is Center for Food Safety and Applied Nutrition
500
After successful completion of all three phases of clinical trials, the sponsor files this
What is New Drug Application (NDA)
500
Product may have only minor advantages over existing products
What is Standard Review
500
The final compound for preclinical studies
What is Preclinical drug candidate