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RegisterBE assessment regarding first time point Cmax [Study Assessment]
Dear ElMaestro and Mann,
I've got an e-mail from Dr. Leon Shargel & Dr. Patrick Noonan who are the authors of "Generic Drug Product Development - Solid Oral Dosage Forms" about the reference of the sentence:
"If these early samples were not collected, then those subjects with first point Cmax values should be dropped from the primary statistical analysis."
E-mail from Dr. Lean Shargel:
"I am sorry that you can not find the appropriate reference. You can email the FDA office of Generic Drugs, Division of Bioequivalence, However, due to Holidays, you may not get a response for some time. In general, the FDA does not like to drop subjects in a BE study. I have had this problem in the past and unfortunately had to re-do the study with a larger subject population. Very costly."
E-mail from Dr. Patrick Noonan:
Dear Erkin and Leon,
I would agree with Leon in that it would be unlikely that a regulatory agency would permit dropping subjects from a BE study. Upon review of the chapter, written quite a long time ago, I don’t agree with my own text. More likely, if a substantial # of subjects exhibit a first point Cmax and the study design didn’t include a sample between 5 and 15 min, the study design may be regarded as inadequate and the study results suspect. My interpretation is that all subjects would be included in the statistical analysis. The older guidance (from 2003) provides a clearer explanation than that provided in the 2013 guidance.
Best regards,
Pat
Patrick K. Noonan, PhD
PK Noonan Pharmaceutical Consulting, LLC
I hope that after ElMaestro's hallucinations
and Dr. Leon Shargel's reviews, dropping subjects due to first point Cmax subject is closed.
Best Regards & Happy New Year,
Erkin
I've got an e-mail from Dr. Leon Shargel & Dr. Patrick Noonan who are the authors of "Generic Drug Product Development - Solid Oral Dosage Forms" about the reference of the sentence:
"If these early samples were not collected, then those subjects with first point Cmax values should be dropped from the primary statistical analysis."
E-mail from Dr. Lean Shargel:
"I am sorry that you can not find the appropriate reference. You can email the FDA office of Generic Drugs, Division of Bioequivalence, However, due to Holidays, you may not get a response for some time. In general, the FDA does not like to drop subjects in a BE study. I have had this problem in the past and unfortunately had to re-do the study with a larger subject population. Very costly."
E-mail from Dr. Patrick Noonan:
Dear Erkin and Leon,
I would agree with Leon in that it would be unlikely that a regulatory agency would permit dropping subjects from a BE study. Upon review of the chapter, written quite a long time ago, I don’t agree with my own text. More likely, if a substantial # of subjects exhibit a first point Cmax and the study design didn’t include a sample between 5 and 15 min, the study design may be regarded as inadequate and the study results suspect. My interpretation is that all subjects would be included in the statistical analysis. The older guidance (from 2003) provides a clearer explanation than that provided in the 2013 guidance.
Best regards,
Pat
Patrick K. Noonan, PhD
PK Noonan Pharmaceutical Consulting, LLC
I hope that after ElMaestro's hallucinations
and Dr. Leon Shargel's reviews, dropping subjects due to first point Cmax subject is closed.Best Regards & Happy New Year,
Erkin
Complete thread:
- BE assessment regarding first time point Cmax Mann 2018-12-09 10:14 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
- BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
- BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
- FDA and outliers mittyri 2018-12-11 16:38
- BE assessment regarding first time point Cmax Erkin 2018-12-28 08:29
- BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
- BE assessment regarding first time point CmaxErkin 2018-12-28 20:57
- regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
- Good question, next question Helmut 2019-03-03 19:42
- first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42
- Good question, next question Helmut 2019-03-03 19:42
- regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
- BE assessment regarding first time point CmaxErkin 2018-12-28 20:57
- BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
- BE assessment regarding first time point Cmax Mann 2018-12-10 00:28
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
Ing. Helmut Schütz