Sometimes its hard to find regulatory guidance documents on the web. One has to scroll through several pages before you actually find what you need. To make things easier, I previously had a webpage where the Bioavailability/Bioequivalence (BA/BE) guidances of various countries were put together under one page. Now, I will be posting the guidance documents on various topics on this blog. Today, I will start with BA/BE and cover as many topics in clincal pharmacology as possible in the future. If you are working in the generics industry and happen to do clinical studies supporting the ANDA (Abbreviated New Drug Application), you may want to bookmark this page and become familiar with following documents.
US FDA
1. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations (Issued 3/2003, Posted 3/19/2003)[PDF]
2. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003)[PDF]3. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Posted 8/31/2000) [PDF]
4. Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003) [PDF]
5. Handling and Retention of BA and BE Testing Samples (5/25/2004) [PDF]
6. Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001)[PDF]
7. Submission of Summary Bioequivalence Data for ANDAs (04/2009) [PDF]
8. Individual Product Bioequivalence Recommendations
9. Bioanalytical Method Validation [PDF]
Note: All links updated
EMEA
1. Guideline on the Investigation of Bioequivalence (July 2008)[PDF]
2. Guidance on the Investigation of Bioavailability and Bioequivalence (July 2001) [PDF]
3. Questions & Answers on the Bioavailabilty and Bioequivalence Guideline (July 2006) [PDF]
4. Reflection Paper on Advice to Applicants/Sponsors/CROs of Bioequivalence Studies (Oct 2007) [PDF]
5. Guidance on Validation of Analytical Procedures: Text and Methodology (June 1995) [PDF]
6. Concept Paper on BCS-Based Biowaiver (May 2007) [PDF]
7. Guidance on Modified Release Oral and Transdermal Dosage Forms(July 1999) [PDF]
CANADA (HPMB)
Bioavailability and Bioequivalence [html]AUSTRALIA (TGA)
Guidance on the Investigation of Bioavailabiliy and Bioequivalence [PDF]
Helmut Schütz also maintains a comprehensive list of BABE guidelines of almost all the countries and you can find it here.
Let me know if I am missing something or if this information is helful to you!
11 comments:
Nice work!
dude ur work is xcellent n it helped me a lot
Anons,
You are welcome! Thanks foe stopping by.
Thanks for this very usefull page, I'll follow your blog in the future. keep going the good work.
f lagarce: Thanks much!
gr8 job dude...
Hi Ganesh,
thanks for linking my site(s)!
My name is spelled "Helmut Schütz"; if you want to link my forum as well, please use BE/BA-Forum (currently the Guideline-collection is linked in the list to the right).
Best regards, Helmut
Hi Helmut,
Thanks for pointing it out. Have made the correction and added a link to your forum as well.
good work. but you have not given any guidelines for Russia, Malaysia and other regulatories. it will be appreciated if we get this info also.
Regards
Sarika
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