Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Repeat BE only for failed analyte	qualityassurance	2026-01-16 12:52	0		866
Robustness of bioequivalence when 90%CI doesn’t include 1 statistical significance ≠ clinical relevance statistical significance ≠ clinical relevance Δ (20% in general)	Darborn	2025-12-23 08:55	3	2025-12-24 09:59	1,962
Comparing two plasma concentration profiles Comparing two plasma concentration profiles Comparing two plasma concentration profiles Comparing two plasma concentration profiles Comparing two plasma concentration profiles MathJax Formulas… Formulas… Negative ƒ2 is possible Interesting, however... Negative ƒ2 is possible	Darborn	2025-10-17 05:40	10	2025-11-07 06:04	4,069
ISR ISR ISR ISR ISR	Loky do	2024-11-21 12:04	4	2024-11-27 14:27	5,428
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	6,986
Group-by-Treatment Interaction (another round)	Helmut	2024-11-27 12:01	0		2,583
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	4,239
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	5,766
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	6,431
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	6,098
Outlier Outlier Visual inspection of the fit!	NK	2023-06-27 03:57	2	2023-06-27 09:56	5,450
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	5,812
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	4,946
AUCtau and Ctau calculation SAP? SAP?	Shatha	2022-08-27 01:36	2	2022-08-27 09:55	5,664
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	5,383