Podcast
Questions and Answers
What is the primary focus of the FDA's guidance on bioavailability and bioequivalence studies?
What is the primary focus of the FDA's guidance on bioavailability and bioequivalence studies?
- To ensure clinical efficacy of drug products
- To evaluate the chemical composition of drug products
- To compare the in vivo performance of different formulations (correct)
- To assess the manufacturing process of drug products
What is the purpose of in vitro dissolution testing?
What is the purpose of in vitro dissolution testing?
- To assess the manufacturing process of drug products
- To compare the bioavailability of different formulations
- To evaluate the chemical composition of drug products
- To predict the in vivo performance of solid oral dosage forms (correct)
What is the primary focus of the FDA's Title 21, Chapter I, Subchapter D?
What is the primary focus of the FDA's Title 21, Chapter I, Subchapter D?
- Medical devices and equipment
- Vaccines and biologics
- Drugs for human use (correct)
- Regulation of food products
What is the primary consideration in demonstrating biosimilarity to a reference product?
What is the primary consideration in demonstrating biosimilarity to a reference product?
What is the term for the ability of a drug to produce the same biological effects as a reference drug?
What is the term for the ability of a drug to produce the same biological effects as a reference drug?
What is the purpose of the FDA's guidance on SUPAC-MR?
What is the purpose of the FDA's guidance on SUPAC-MR?
What is the primary focus of the FDA's guidance on changes to an approved NDA or ANDA?
What is the primary focus of the FDA's guidance on changes to an approved NDA or ANDA?
What is the purpose of in vitro dissolution testing?
What is the purpose of in vitro dissolution testing?
What is the purpose of the ICH guidance, Q3A?
What is the purpose of the ICH guidance, Q3A?
What is the consequence of increased competition from generic drugs in the pharmaceutical industry?
What is the consequence of increased competition from generic drugs in the pharmaceutical industry?
What is the primary concern when a manufacturer makes changes to a drug product?
What is the primary concern when a manufacturer makes changes to a drug product?
What is the concern regarding generic substitution of antiepileptic drugs?
What is the concern regarding generic substitution of antiepileptic drugs?
What type of change requires the submission of a supplement and approval by the FDA prior to distribution of the drug product?
What type of change requires the submission of a supplement and approval by the FDA prior to distribution of the drug product?
What is the reporting requirement for a moderate change?
What is the reporting requirement for a moderate change?
What is the relevance of the CFR Part 320 in regards to drug regulation?
What is the relevance of the CFR Part 320 in regards to drug regulation?
What type of change has a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product?
What type of change has a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product?
How must minor changes be reported to the FDA?
How must minor changes be reported to the FDA?
What is the purpose of the FDA reporting requirement for changes to an approved drug product?
What is the purpose of the FDA reporting requirement for changes to an approved drug product?
