Biowaivers Drs. Jan Welink WHO Workshop on Prequalification of Medicines Programme, Abu Dhabi, 11-13 October, 2010 Guidance  WHO – Technical Report Series No. 937, May…

Slide 1Training workshop on Pharmaceutical Quality, Good Manufacturing Practice & Bioequivalence, Kiev 3.-7.10.2005 Regulation documentation requirements Saila Antila,…

ASEAN GUIDELINES FOR THE CONDUCT OF BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES FINAL DRAFT : 21 JULY 2004 Adopted from the “NOTE FOR GUIDANCE ON THE INVESTIGATION OF BIOAVAILABILITY…

* Regulatory Guidance on BioAvailability and BioEquivalence Studies FDA and EMA Guidances Outline Overview of BA and BE studies Methodology PK studies In-vitro studies BE…

Slide 1 Exercise 6 Dose linearity and dose proportionality Slide 2 Objectives of the exercise To learn what is dose linearity vs. dose proportionality To document dose proportionality…

Slide 1 REGISTRATION OF MEDICINES & PROGRESS WITH RESTRUCTURING THE MCC 1 Slide 2 OUTLINE Obligations & Functions Elements of effective regulation Requirements new…

Slide 1 1 V01/Dec09 1 CADILA CRO Clinical Research Slide 2 2 V01/Dec09 Objective & Goals Our Goal: To be a leading CRO in the world using committed resources & to…

ArTiMist⢠Clinical Trial Results By Mr Calvin Ross Sofitel Wentworth Hotel Sydney 14 April 2008 Eastland Medical Systems Ltd Eastland Medical Systems Eastland Medical…

    Healthcare Sector in India  Monthly Update  February 2012        Top Story    Therapeutic cancer vaccine to go for human clinical trials soon   …

1. QPS – Xcellent Servicesis your Global LinkOverview of QPS’ full suite of linearly integratedpreclinical and clinical ADME services 2. QPS – Xcellent Servicesis your…