'Bioequivalence' diaporamas de présentation

1.67k views • 166 slides

Outline

Statistical Methods for Assessment of Individual/Population Bioequivalence Shein-Chung Chow, Ph.D. Biostatistics and Clinical Data Management Millennium Pharmaceuticals, Inc. Cambridge, MA 02139 Presented at ASA Boston Chapter December 2, 2003. Outline. Background What and Why? History

695 views • 58 slides

Exercise 5 Monte Carlo simulations, Bioequivalence and Withdrawal time

Exercise 5 Monte Carlo simulations, Bioequivalence and Withdrawal time. Objectives of the exercise. To understand regulatory definitions of Bioequivalence and Withdrawal time To understand the principles and goals of Monte Carlo simulation (MCS)

855 views • 56 slides

Quality Assurance GMP: "Guide to Good Pharmaceutical Manufacturing Practice"

813 views • 47 slides

Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Wa

Pharmaceutical Development. Training Workshop on Pharmaceutical Development with focus on Paediatric Formulations Protea Hotel Victoria Junction, Waterfront Cape Town, South Africa Date: 16 to 20 April 2007. Pharmaceutical Development. Developing formulation and manufacturing proce ss

872 views • 45 slides

ERT 420 BIOPHARMACEUTICAL ENGINEERING Semester 1 Academic Session 2012/2013

ERT 420 BIOPHARMACEUTICAL ENGINEERING Semester 1 Academic Session 2012/2013. HUZAIRY HASSAN School Of Bioprocess Engineering Universiti Malaysia Perlis. DRUG BIOAVAILABILTY & BIOEQUIVALENCE. Drug Absorption & Bioavailability.

441 views • 31 slides

Coordinators :

Bioequivalence , data exclusivity and generic drugs An analysis from the cases of India and Brazil. Coordinators : Fabienne Orsi (IRD-SE4S, Marseille) and Claudia Chamas ( Fiocruz, Rio de Janeiro) Research Team :

213 views • 11 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