Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
ISR ISR ISR ISR ISR	Loky do	2024-11-21 12:04	4	2024-11-27 14:27	1,960
First Point Cmax USFDA First Point Cmax (also ICH M13A) First Point Cmax (also ICH M13A) FDA M13A First Point Cmax (also ICH M13A)	NK	2024-09-13 06:48	4	2024-11-27 13:50	2,860
Group-by-Treatment Interaction (another round)	Helmut	2024-11-27 12:01	0		992
reason to exclude volunteer FDC: No measurable concentrations of one drug FDC: No measurable concentrations of one drug	Loky do	2024-11-10 11:52	2	2024-11-10 12:48	1,503
Decrease in PSD: Need to repeat BE? Type-II Variation Type-II Variation: Waive in-vivo study by providing in-vitro data? Type-II Variation: Waive in-vivo study by providing in-vitro data? Type-II Variation: Waive in-vivo study by providing in-vitro data?	qualityassurance	2024-07-02 08:32	4	2024-07-04 12:19	2,904
Half life longer than literature (or well known) half-life Explain it in the report Explain it in the report Don’t worry, be happy! Don’t worry, be happy!	jag009	2023-12-06 04:19	4	2023-12-07 16:36	3,381
Zero Data in Suppositories BE Test Zero Data in Suppositories BE Test Zero Data in Suppositories BE Test Zero Data in Suppositories BE Test	Siswanto	2023-08-12 09:18	3	2023-08-15 11:07	3,519
Outlier Outlier Visual inspection of the fit!	NK	2023-06-27 03:57	2	2023-06-27 09:56	2,976
Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies Isotretinoin Capsules 40 mg fed studies	Venkata Chaitanya Reddi	2023-06-14 10:19	4	2023-06-16 08:48	3,094
Linagliptin/Metformin Hydrochloride film-coated tablets Linagliptin/Metformin Hydrochloride film-coated tablets Linagliptin/Metformin Hydrochloride film-coated tablets	Venkata Chaitanya Reddi	2023-06-09 07:18	2	2023-06-09 12:01	2,771
AUCtau and Ctau calculation SAP? SAP?	Shatha	2022-08-27 01:36	2	2022-08-27 09:55	3,384
BE study results Evaluation Sample size based on ‘overpowered’ study Sample size based on ‘overpowered’ study Sample size based on ‘overpowered’ study	Vaibhav	2022-06-14 20:57	3	2022-06-16 08:43	3,114
Center term in Bioequivalence Study Few subjects and many centers… Center term in Bioequivalence Study	balakotu	2022-06-08 08:03	2	2022-06-08 11:14	3,593
Reanalysis of volunteers Reanalysis of volunteers	Loky do	2022-03-16 09:10	1	2022-03-16 15:37	2,973
William's OR Latin square design Williams’ OR Latin square design Williams’ OR Latin square design	Bebac user	2022-03-10 11:45	2	2022-03-10 18:26	3,189