'Reference drug' presentation slideshows

Regulation documentation requirements

Regulation documentation requirements. Saila Antila, PhD WHO consultant. Guidelines. WHO: Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products / Regulatory Support Series, No 5 (WHO/DMP/RGS/98.5) continues. Guidelines ( continues).

772 views • 44 slides

Capecitabine

909 views • 23 slides

GADA Quarterly Meeting October 8, 2009

GADA Quarterly Meeting October 8, 2009 . Dr. Ken Harshman, Director Division of Generic Animal Drugs. Comparative Dissolution for Solid Oral Dosage Forms. Principle: evidence must be provided to establish in vivo bioequivalence for all strengths of the generic drug Types of evidence

239 views • 12 slides

Date: 7/4/2016 By: Mahmoud Mostafa

132 views • 11 slides