US Drug Regulatory Affairs: A Comprehensive Overview PART 2
Rohan Jindal
M.Pharm (Pharmaceutical Analysis) | UIPS, Panjab University | GPAT Qualified | Class of 2024-2026
9. Types and Timings of Non-Clinical Studies
?Safety pharmacology: Before human trials to assess major organ system effects.
?Subchronic toxicity studies: Lasting for up to 90 days.
?Chronic toxicity studies: Conducted for drugs intended for long-term use.
?10. Exploratory IND
?An Exploratory IND allows early-stage clinical trials to begin with limited dosing to assess the drug's pharmacokinetics and pharmacodynamics before full development.
?11. Patent & Exclusivity
?Patent protection and market exclusivity offer innovators exclusive rights to market their drugs. This protection helps recoup R&D investments. Exclusivity can last from 180 days to 7 years depending on the drug category (e.g., Orphan Drug).
?12. Orphan Drug Designation in the US
?The Orphan Drug Act provides incentives for developing drugs that treat rare diseases, affecting fewer than 200,000 people in the US. Orphan drugs receive tax credits, grant funding, and seven years of marketing exclusivity.
?13. Drug Discovery Timelines in the US
?The timeline from drug discovery to approval can span 10-15 years. It begins with preclinical testing, moves into Phase I-III clinical trials, and ends with NDA filing and post-marketing surveillance.
?14. Clinical Trial and Clinical Research
?Clinical trials test the drug in humans to determine safety, efficacy, and dosage. These trials occur in four phases:
?Phase I: Small group testing for safety.
领英推荐
?Phase II: Larger group testing for efficacy and safety.
?Phase III: Large-scale trials for definitive testing.
?Phase IV: Post-marketing surveillance.
?15. Clinical Trial Protocol
?A clinical trial protocol outlines the study design, participant criteria, drug dosage, treatment schedule, and endpoints. This ensures that trials are conducted ethically and produce reliable data.
?16. Ethics in Clinical Trial
?Ethics in clinical trials are upheld by strict guidelines, including Institutional Review Board (IRB) oversight, informed consent, and protecting vulnerable populations from harm.
?17. Informed Consent
?Participants in clinical trials must be fully informed about the potential risks and benefits of the trial through the informed consent process, ensuring their voluntary participation.
?18. FDA Forms and How to Fill Them
?Submitting drug applications requires various FDA forms:
?Form 1571: IND application.
?Form 356h: NDA or ANDA submission.
?Form 1572: Statement of Investigator. Ensuring correct completion of these forms is critical for regulatory compliance.