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priyanka ☆ 2008-04-29 16:27 (6636 d 14:00 ago) Posting: # 1804 Views: 3,755 |
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Dear all, I want to know in which situation Average BE, Population BE & Individual BE will need. |
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Jaime_R ★★ Barcelona, 2008-04-29 16:31 (6636 d 13:55 ago) @ priyanka Posting: # 1805 Views: 3,066 |
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Dear Priyanka, IMHO Population BE & Individual BE are only of historical interest... — Regards, Jaime |
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priyanka ☆ 2008-04-29 16:41 (6636 d 13:45 ago) @ Jaime_R Posting: # 1806 Views: 2,994 |
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Dear Jaime If possible then please provide more information about it. Thanks in advance |
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Jaime_R ★★ Barcelona, 2008-04-29 17:02 (6636 d 13:25 ago) @ priyanka Posting: # 1807 Views: 3,223 |
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Dear Priyanka, please do your homework first and have a look at the guidance collection.  PBE and IBE are simply not mentioned in almost all countrie's and WHO's guidelines. Although PBE/IBE are mentioned in FDA's 'Statistical Approaches to Establishing Bioequivalence' (Jan 2001); there's no more reference in 'Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations' (Mar 2003). Technically PBE is recommended for some types of in vitro studies: 'Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action' (Draft Apr 2003); technical appendix. -- Edit: FDA-link corrected to latest archived copy. [Helmut] — Regards, Jaime |
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d_labes ★★★ Berlin, Germany, 2008-05-05 13:45 (6630 d 16:41 ago) @ Jaime_R Posting: # 1815 Views: 2,997 |
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Dear Jaime, ❝ IMHO Population BE & Individual BE are only of historical interest... Although it is common belief that history does never recur it is an outstanding thing with that. You are right in stating: ❝ PBE and IBE are simply not mentioned in almost all countrie's and WHO's ❝ guidelines. So one may reasonable expect that PBE and IBE in the strict sense discussed around the year 2000 and up to this time will not recure. But I bet my sparse bucks that aspects of these approaches will recur. In the present I notice an increasing number of questions from sponsors to do bioequivalence studies with a replicate design or deficiency statements from european regulatories regarding studies with a non-replicate design that should have done with a replicate design (at least in the belief of that regulator). This is especially the case for claims regarding broadened bioequivalence margins for highly variable drugs. Although not essentially part of the ABE statement within the framework of such studies you have to deal automatically during evaluation of such studies with the questions: - Are the obtained variance components (intra- and/or inter-subject variability) of the test and reference formulations really different? This is the basic question behind PBE. - Is the obtained variance component for the subject-by-formulation interaction significant (i.e. >0 or greater some value regarded meaningfull)? This is the basic question behind IBE. Thus it would be wise to be prepared and not to trust in hope that history is past. — Regards, Detlew |
Ing. Helmut Schütz