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REGULATORY GUIDELINES FOR PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINES

REGULATORY GUIDELINES FOR PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINES. BY. Dr. Basavaraj K. Nanjawade Associate Professor of Pharmaceutics Department of Pharmacology JN Medical College Belgaum-10 e-mail: bknanjwade@yahoo.co.in. Traditional Medicine.

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640 views • 39 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.

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688 views • 28 slides

Investigational New Drug Applications: two cases

Investigational New Drug Applications: two cases . April 15, 2009. Carine M. Lenders, M.D., M.S. Medical Director, NFL program Director, Pediatric Nutrition Support Services Research Staff, General Pediatrics Assistant Professor of Pediatrics. Objectives.

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415 views • 14 slides

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Previous human experience - PowerPoint PPT Presentation

REGULATORY GUIDELINES FOR PRECLINICAL AND CLINICAL VALIDATION OF TRADITIONAL MEDICINES

What Is An IND?

Investigational New Drug Applications: two cases