Bioequivalence and Bioavailability Forum

Dear Rahul,

the workshop is organised the Shivrath Center of Excellence in Clinical Research (Dr. Bhagirath Patel) and Synchron (Dr. Shivprakash Rathnam). Please use contacts on their respective websites. The workshop is limited to 35 seats.

An overview of the program is given below:
Shivprakash Rathnam (Managing Director Synchron Research, Chief Editor Indian Journal of Pharmacology):
  Pharmacokinetics
Tony Martin (ThermoFisher, Technical Manager, EMEA):
  Integrated Drug Metabolism and Pharmacokinetics Software Solution
Myself (BEBAC Consultancy Services for Bioequivalence and Bioavailability Studies):
  Study Design and Evaluation Issues:
  1 Analytical Development and Validation
  2 Clinical Part of Phase I Studies
  3 Statistical Design and Analysis
Simon Davis (Senior Scientific Consultant, Pharsight, UK):
  Using WinNonlin AutoPilot and PKS to generate TFLs rapidly and effectively in BA/BE studies
Salomon Stavchansky (The University of Texas at Austin, Pharmaceutical Division):
  Global Guidelines
Anders Fuglsang (Norwegian Medicines Agency, Member of EMEA's Efficacy Working Party, Chair of EWP Work Group on Orally Inhaled Products):
  Inhalation Products BE Studies
Ganapathy Ramakrishnan (Managing Director, ThermoFisher Scientific, India):
  Advanced Laboratory Instruments for the Bioanalysis and Bioequivalence market
Jean-Michel Cardot (Dept. of Biopharmaceutical and Pharmaceutical Technology, University of Auvergné, Clermont-Ferrand, France):
  1 Biopharmaceutical Classification System
  2 IVIVC
Simon Davis (Senior Scientific Consultant, Pharsight, UK):
  Pharsight Demonstration of IVIVC using WinNonlin to complement IVIVC workshop Training

Dear Rahul,

The most responsive email contact I have at this group is Rachana who can be reached on
shivrathclinicalgmail.com.

Incidentally some of you may be interested to know there was quite an interesting webinar last week that is currently available for replay on the Pharsight website:
Pharsight's Critical Path Approach for Development of Generic Products
Date: November 12, 2008
Time: 10:00am - 11:00am EST
Speakers: Jean-Francois Marier, PhD, FCP, Vice President & Lead Scientist, Reporting and Analysis Services; Jean-Sébastien Brunet, MSc, Senior Associate, Statistics and Data Management, Reporting and Analysis Services.

This webinar presents state-of-the-art pharmacokinetic and statistical analyses that can be used to assess bioequivalence of locally acting and highly variable drugs. The webinar will also present multiple examples showing how Pharsight's approach can save time and money in the development of a generic product with the use of IVIVC, biowaivers, bioassay validation, short-paneled or under-recruited studies, interim analysis, sequential bioequivalence studies, and sample pooling for preliminary assessment of bioequivalence.

---

Edit (@Simon): E-mail address removed to prevent spamming. Commercial content removed according to the Forum's Policy. For training & events see Pharsight's website. [Helmut]

Dear HS,

slide for same presentation put two times while last presentation has not been attached for Lecture taken at Ahmedabad.

Regards,
Kaushal