'Investigational new drug applications' diaporamas de présentation

Gender Aspects in Drug Development and Approval The American Experience

683 views • 46 slides

Regulatory Framework for Phase I & Clinical Pharmacology Studies

Regulatory Framework for Phase I & Clinical Pharmacology Studies. Funmilayo O. Ajayi, PhD, FCP, FIST Procter & Gamble Cincinnati, Ohio. Talk Overview. Background Information: history of drug approval regulation drug development paradigm Pre-clinical Studies & Required Data for IND

599 views • 43 slides

Facilitating Biologics Product Development to Address Threats to Food Security

Facilitating Biologics Product Development to Address Threats to Food Security. Jesse L. Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation & Research (CBER) FDA. CT: CBER Roles and Products. Roles: Facilitate Product Development

458 views • 31 slides

What Is An IND?

What Is An IND?. Loris McVittie, PhD. OVRR/CBER/FDA. Regulation. The regulations in 21 CFR 312 cover procedures and requirements for Investigational New Drug Applications (INDs) These regulations define the roles and responsibilities of FDA reviewers, IND sponsors, and clinical investigators.

604 views • 28 slides

The Role of Chemists in the FDA Drug Approval Process

The Role of Chemists in the FDA Drug Approval Process. 231 st ACS National Meeting Atlanta, GA M. Scott Furness, Ph.D. March 26, 2006. Presentation Outline. Introduction FDA Organization CDER Organization Drug Approval Process Role of Chemistry Reviewers within CDER

439 views • 24 slides

Overview of FDA's Regulatory Framework for PET Drugs

Overview of FDA's Regulatory Framework for PET Drugs. Ravindra K. Kasliwal, Ph.D . Office of New Drug Quality Assessment Center for Drug Evaluation and Research U. S. Food and Drug Administration. Background.

323 views • 17 slides