Bioequivalence and Bioavailability Forum • 90% CIs for BE?

90% CIs for BE? [🇷 for BE/BA]

posted by yjlee168 – Kaohsiung, Taiwan, 2008-11-17 19:26 (6412 d 12:26 ago) – Posting: # 2699
Views: 15,660

dear Helmut,

❝ Yes! :crying:

That's terrible. They have a program called "...a Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER)..." and "... Under the terms of the CRADA, Pharsight will provide the FDA with software for the analysis, visualization, storage, reporting and review of PK/PD data. The specific Pharsight products covered by the CRADA include:

* Pharsight Knowledgebase Server™ (PKS™)
* PKS Validation Suite™
* WinNonlin^®...[quoted from Pharsight CRADA website]

Does that imply that USA FDA can accept Westlake's approach? Or there is nothing to do with this?

—
All the best,
-- Yung-jin Lee
bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan https://www.pkpd168.com/bear
Download link (updated) -> here

Complete thread:

90% CIs for BE? yjlee168 2008-11-17 08:52
- 90% CIs for BE? ElMaestro 2008-11-17 09:46
- 90% CIs for BE? d_labes 2008-11-17 13:07
  - There can be only one! Helmut 2008-11-17 17:12
- 90% CIs for BE? Helmut 2008-11-17 13:30
  - 90% CIs for BE? ElMaestro 2008-11-17 13:51
    - 90% CIs for BE? d_labes 2008-11-17 13:56
  - 90% CIs for BE? yjlee168 2008-11-17 18:10
    - 90% CIs for BE? Helmut 2008-11-17 18:14
      - 90% CIs for BE?yjlee168 2008-11-17 18:26
        
        90% CIs for BE? ElMaestro 2008-11-17 19:49