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RegisterPBE, IBE [Regulatives / Guidelines]
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.
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Edit: FDA-link corrected to latest archived copy. [Helmut]
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]
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Regards, Jaime
Regards, Jaime
Complete thread:
- use of different types of BE priyanka 2008-04-29 14:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PBE, IBE Jaime_R 2008-04-29 14:31
- PBE, IBE priyanka 2008-04-29 14:41
- PBE, IBEJaime_R 2008-04-29 15:02
- History is not past d_labes 2008-05-05 11:45
- PBE, IBEJaime_R 2008-04-29 15:02
- PBE, IBE priyanka 2008-04-29 14:41
- PBE, IBE Jaime_R 2008-04-29 14:31
Ing. Helmut Schütz