link to Chinese BE-Guideline [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2020-05-26 00:16 (1852 d 18:13 ago) – Posting: # 21466
Views: 2,227

Dear Dan,

❝ Could anybody provide the correct link to the Chinese BE-Guideline? http://www.sfda.gov.cn/directory/web/WS01/images/MjAxNsTqtdo2MbrFzai45ri9vP4zLmRvY3g=.docx

❝ as mentioned under BEBAC/Guidelines/China gives an error message.:-(


They changed the website. You can find all guidance at this link.

Specifically, Guidance for PK-based BE, for HVDP, and for statistics.

The general link above contains much more (for chemical compounds) in case you are interested. For others such as biological products, follow the link in the left panel on that pages.

All the best,
Shuanghe

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
52 visitors (0 registered, 52 guests [including 12 identified bots]).
Forum time: 18:29 CEST (Europe/Vienna)

Medical researches can be divided into two sorts:
those who think that meta is better and those
who believe that pooling is fooling.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5