Bioequivalence and Bioavailability Forum

BE in Chinese Pharmacopoeia [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-06-14 16:22 (4756 d 01:18 ago) – Posting: # 10792
Views: 16,244

Hi Shuanghe!

❝ Helmut, i don't know how to upload to your web

Doesn’t work. Only image-uploads are possible here.

❝ but you can download the pdf file here:

❝ http://wenku.baidu.com/view/e641f7fdc8d376eeaeaa3171.html

THX; I will add the link to the Guideline-collection. BTW, is calculation of AUC_0→∞ as AUC_0→tn+C_tn/λ_z (given on page 5) mandatory or just a suggestion, i.e., can one use the estimated C_tn instead?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Add more subjects after a failed BE study of a HVD wxp 2013-05-27 10:34
- bad luck Dr_Dan 2013-05-27 12:28
  - bad luck wxp 2013-05-27 14:19
- Beware of Add-on Studies! Helmut 2013-05-27 13:51
  - Beware of Add-on Studies! Shuanghe 2013-05-27 15:59
    - Oh wow! Helmut 2013-05-27 16:21
      - The same criterion of Cmax in China now wxp 2013-05-28 06:10
        
        SFDA ⇒ CFDA Helmut 2013-05-28 13:02
        
        Helmut, updated Chinese BE guideline here Shuanghe 2013-06-14 11:05
        
        BE in Chinese PharmacopoeiaHelmut 2013-06-14 14:22
        
        BE in Chinese Pharmacopoeia Shuanghe 2013-06-14 14:56
        
        BE in Chinese Pharmacopoeia Helmut 2013-06-14 16:11
  - Add more subjects after a failed BE study of a HVD wxp 2013-05-28 05:13
    - Still many subjects… Helmut 2013-05-28 12:56

BE in Chinese Pharmacopoeia [Study As­sess­ment]

Complete thread:

BE in Chinese Pharmacopoeia [Study Assessment]