Bioequivalence and Bioavailability Forum • Guidance Documents

Guidance Documents [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2006-01-21 00:28 (7446 d 06:46 ago) – Posting: # 59
Views: 89,407
(edited on 2007-10-09 21:03)

Dear all,

I prepared a Collection of Links to Regulatory Guidances.

Enjoy!

Dear all,
following Prakash’s suggestion I added links to some GCP guidelines (namely ICH, WHO, EU, PAHO) to the guidance page.
Please see also my remarks concerning national legal regulations.

Recent additions

Malaysia and Argentia: GCP guidelines.
WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth Report (WHO Technical Report Series No. 937)
European Union: Definition of IMPs and NIMPs, Scientific Advice & Protocol Assistance, Reporting Results of Population PK Analyses, Concept Paper on BA/BE for HVDs/HVDPs, Questions & Answers on the BA and BE Guideline
Denmark: Bioequivalence and labelling of medicinal products with regard to generic substitution

USA: Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling
Canada: Records Related to Clinical Trials, BE for Critical Dose Drugs
South Africa: Pharmaceutical and Analytical Guideline, Biostudies, Dissolution
Brazil: Implementation of Relative BA and BE Studies
Japan: All BE Guidelines were revised with 24 November 2006, Q&A-Documents were also published. No English translations are available as of today (05 Dec 2006).

Argentia: BA/BE guidelines (in Spanish) based on WHO’s TRS No. 937; a very interesting document, covering not only the common 2×2 cross-over, but also add-on designs, parallel groups and replicate designs.
USA: BE Recommendations for Specific Products ordered by API.
OECD, WHO, EU, FDA: Guidelines on Good Laboratory Practice (GLP)
Taiwan: Various Guidelines (Chinese versions; thanks to Yung-jin Lee providing the links)

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

Guidance DocumentsHelmut 2006-01-20 23:28 [Regulatives / Guidelines]
- alternative sources… Helmut 2007-02-20 16:16
- requests for update Helmut 2007-08-14 20:30
- ▌Regulatory requirements▐ Helmut 2007-09-14 13:18
- Redesign of FDA’s website :-( Helmut 2009-06-08 15:24