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RegisterHighly Variable Drug BE Justification [Regulatives / Guidelines]
Hi all,
Just want to know what your experience is on this matter.
The FDA stated that "Special Considerations: Applicants may consider using a reference-scaled average bioequivalence approach for x drug. If using this approach, the applicant should provide evidence of high variability (i.e., within-subject variability ≥30%) in bioequivalence parameters. Applicants who would like to use this approach are encouraged to submit a protocol for review by the Division of Bioequivalence in the Office of Generic Drugs."
The above implies that one can conduct replicate studies (RSABE) if he/she has supportive data (ISCV>=30%). What if one conducted pilot studies and found that the ISCV is like 28/29%? My concensus still would be to proceed with RSABE approach since the it is a mixed approach which allows both RSABE (if Ref SD<0.294) and ABE analysis (if Ref SD>0.294)
John
Just want to know what your experience is on this matter.
The FDA stated that "Special Considerations: Applicants may consider using a reference-scaled average bioequivalence approach for x drug. If using this approach, the applicant should provide evidence of high variability (i.e., within-subject variability ≥30%) in bioequivalence parameters. Applicants who would like to use this approach are encouraged to submit a protocol for review by the Division of Bioequivalence in the Office of Generic Drugs."
The above implies that one can conduct replicate studies (RSABE) if he/she has supportive data (ISCV>=30%). What if one conducted pilot studies and found that the ISCV is like 28/29%? My concensus still would be to proceed with RSABE approach since the it is a mixed approach which allows both RSABE (if Ref SD<0.294) and ABE analysis (if Ref SD>0.294)
John
Complete thread:
- Highly Variable Drug BE Justificationjag009 2017-03-20 04:42 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
- Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
- Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
- Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
- Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
- expected power d_labes 2017-03-21 15:16
- Doesn't hurt! VStus 2017-03-23 14:24
- Study costs: Replicate seems to be cheaper Helmut 2017-03-21 14:50
- Study costs: Replicate seems to be cheaper Dr_Dan 2017-03-21 13:06
- Study costs: Replicate vs. 2×2×2 mahmoud-teaima 2017-03-23 08:17
- Study costs: Replicate vs. 2×2×2 M.tareq 2017-05-07 21:21
- Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
- Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
- Applicability of reference-scaling Helmut 2017-05-10 14:10
- Replicate vs. 2×2×2 M.tareq 2017-05-14 23:04
- Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
- Replicate vs. 2×2×2 M.tareq 2017-05-15 21:02
- Regulators view of HVD drugs DavidManteigas 2017-05-16 12:41
- Regulators view of HVD drugs Helmut 2017-05-16 15:01
- What's the problem? ElMaestro 2017-05-17 03:30
- What's the problem? nobody 2017-05-17 07:48
- What's the problem? nobody 2017-05-17 09:31
- What's the problem? DavidManteigas 2017-05-17 11:25
- What's the problem? ElMaestro 2017-05-17 12:07
- What's the problem? kumarnaidu 2017-07-11 14:43
- What's the problem? ElMaestro 2017-07-11 14:56
- What's the problem? kumarnaidu 2017-07-11 14:43
- What's the problem? ElMaestro 2017-05-17 12:07
- What's the problem? DavidManteigas 2017-05-17 11:25
- What's the problem? nobody 2017-05-17 09:31
- What's the problem? nobody 2017-05-17 07:48
- Replicate vs. 2×2×2 Helmut 2017-05-15 19:07
- Replicate vs. 2×2×2 (ethics?) nobody 2017-05-08 14:52
- Replicate vs. 2×2×2 (ethics?) Helmut 2017-05-08 14:21
- Study costs: Replicate seems to be cheaper VStus 2017-03-21 12:49
- Study costs: Replicate vs. 2×2×2 Helmut 2017-03-20 13:12
- Highly Variable Drug BE Justification ElMaestro 2017-03-20 06:55
Ing. Helmut Schütz