Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
schedule time vs. actual time for ANVISA BE schedule time for ANVISA? schedule time vs. actual time for ANVISA BE Not even wrong Not even wrong ANVISA: MD studies no more required Relatorio estatistico Relatorio estatistico ANVISA ANVISA Relatorio estatistico Full book? schedule time vs. actual time for ANVISA BE schedule time vs. actual time for ANVISA BE TPD? TPD? TPD! schedule time vs. actual time for ANVISA BE schedule time vs. actual time for ANVISA BE	Shuanghe	2022-07-10 00:36	18	2022-07-25 10:32	1,721
Drug-Drug Interaction procedure -between inhalation and oral Tab Relax & cool down ?	Mr.Rao	2022-07-15 08:47	1	2022-07-15 07:54	833
Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph Conflicts of interest (COI) Off topic Off topic Off topic CRO belong to the pharmaceutical Company (CRO b2Ph CRO belong to the pharmaceutical Company (CRO b2Ph CRO subsidiary of pharmaceutical company	wienui	2022-07-07 10:37	11	2022-07-09 17:21	1,617
BMI BMI in the protocol BMI in the protocol BMI in the protocol	Loky do	2022-06-26 17:05	3	2022-06-29 12:44	922
Unequal variances in parallel design Welch’s t-test Welch’s t-test Welch’s t-test Welch’s t-test Read the paper, use the code(s)!	Imph	2022-06-20 16:16	5	2022-06-26 10:12	1,046
Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission Sevelamer Carbonate In vitro binding study for EMA submission	jansari	2021-09-24 19:03	5	2022-05-27 16:54	1,377
Handling large Extrapolated AUC Values residual area < 20% for more than 80% subjects residual area < 20% for more than 80% subjects Exclusion for the FDA?	Sereng	2022-05-12 17:17	3	2022-05-23 09:43	838
Bioequivalence study of sertraline HCL capsule Do your homework first	Vishal S	2022-05-16 14:40	1	2022-05-16 13:48	658
BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both? BE Confidence Interval Criteria: AUC(t) or AUC(inf) or both?	Sereng	2022-05-12 17:14	1	2022-05-12 20:14	667
ICH guideline M10 on BA method validation Stock solutions for CCs and QCs ICH guideline M10 on BA method validation	PSU	2022-05-03 15:53	2	2022-05-05 09:47	778
BE study for China	jag009	2022-04-14 19:06	0		692
Bioequivalence studies at night Bioequivalence studies at night	Loky do	2022-03-28 12:36	1	2022-03-28 12:23	983
Kel Calculation in ANVISA Regulatory Data, please ANVISA’s strange examples R2adj improvement limit R2adj improvement limit	MGR	2022-03-21 07:30	4	2022-03-22 13:04	3,472
Potvin method is acceptable or not for FDA Potvin method is acceptable or not for FDA Simulation-based methods acceptable for the FDA	khageswara Rao	2022-03-21 12:10	2	2022-03-21 12:32	894
Corrections for Potency Typos… Typos… Typos… Typos… Typos… Wrong formula for CV	Shatha	2022-03-20 14:51	6	2022-03-21 09:02	1,015