FDA培训：论证仿制药中辅料的安全性.pdf

Bridging Justifications: Supporting the Safety of Excipients in Generic Drug Products Robert T. Dorsam, Ph.D. Office of Generic Drugs (OGD) Division of Clinical Review (DCR) Pharmacology/Toxicology Team Leader Disclaimer The opinions expressed in this presentation are those of the speaker and may not reflect the position of the U. S. Food and Drug Administration 2 Outline • Excipient safety review in generic drug applications • Bridging justifications for excipients in generic drugs – What is their utility? – What are important factors to consider? • Case Studies – Excipient grade, dose, duration, route of administration, patient population 3 3 Excipient safety review: OGD Pharm/Tox • Bridging justifications are a subset of the safety assessments conducted by OGD Pharm/Tox team • Excipient safety review is conducted on a consult basis: – Consulted by OGD and Office of Pharmaceutical Quality (OPQ) on a fraction of OGD’s applications – When there is a safety question (i.e. exceeds approved level, question of excipient grade, route) • P/T and Clinical reviewers evaluate safety of excipients – Clinical informs context of use for product, clinical safety – Pharm/Tox evaluates available nonclinical safety information 4 4 Excipient Safety Assessments • The review is focused on