'Bioequivalence study' presentation slideshows

Statistical considerations

913 views • 53 slides

Substantial Evidence of Drug Effectiveness

Substantial Evidence of Drug Effectiveness. Cindy L. Burnsteel, DVM Division of Therapeutic Drugs for Food Animals Center for Veterinary Medicine. March 7, 2002. In order for a New Animal Drug to be approved: . FDA must find, among other things, that:

758 views • 35 slides

Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification System.

Multisource (generic) products and Interchangeability . Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification System. Hotel Bratislava 1 Malyshko Street Kyiv, Ukraine Date: 25 to 27 June 2007.

502 views • 31 slides

Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification System.

Multisource (generic) products and Interchangeability . Training Workshop on Dissolution, Pharmaceutical Product Interchangeability and Biopharmaceutical Classification System. Hotel Bratislava 1 Malyshko Street Kyiv, Ukraine Date: 25 to 27 June 2007.

453 views • 31 slides

Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO Accra, 5.

Training workshop on regulatory requirements for registration of Artemisinin based combined medicines and assessment of data which are submitted to regulatory authorities. Choice of comparators An Introduction to Bioequivalence Studies Presented by: Hans Kemmler, Consultant to WHO

285 views • 14 slides

Bioequivalence of Highly Variable Drugs

Bioequivalence of Highly Variable Drugs. Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER, FDA ACPS Meeting, October 6, 2006. 2004 ACPS Meeting Bioequivalence of Highly Variable Drugs. Introduction (5 min) Lawrence Yu, Ph.D.

254 views • 7 slides