Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
BioBridges 2019 – invitation & preliminary program	Conferences / Workshops	Helmut	2019-06-29 13:06	0		13,760
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		73,806
Appropriate wording for a protocol Appropriate wording for a protocol Appropriate wording for a protocol Appropriate wording for a protocol Which country? Which country? EEU-rules, TSD-methods (lengthy answer) EEU-rules, TSD-methods (lengthy question)	Two-Stage / GS Designs	Elena777	2019-09-09 19:34	7	2019-09-14 14:56	380
Input for CV when small first-in-man has been run Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Assumptions… Assumptions… Assumptions… Assumptions… t-test & Welch-test	Power / Sample Size	Rocco_M	2019-09-03 18:45	13	2019-09-14 00:16	546
predicting in vivo PK profiles from in vitro data after establishing IVIVC external predictability for ivivc external predictability for ivivc identical pH identical pH R scripts/codes for in-vivo conc. Software validation, another round Deconvolution Software validation, another round Software validation, another round Software validation, another round Should we also consider to validate the validation? Who inspects the inspectors? Who inspects the inspectors? Sapienti sat R scripts/codes for in-vivo conc. Bioavailabity term in predicted in-vivo conc.	Dissolution / BCS / IVIVC	amer	2019-09-09 05:04	16	2019-09-13 12:59	493
Evaluation of Heparin as a potentially interfering substance Evaluation of Heparin as a potentially interfering substance Evaluation of Heparin as a potentially interfering substance Evaluation of Heparin as a potentially interfering substance	Bioanalytics	Monic	2019-09-11 14:04	3	2019-09-11 21:25	143
2020 events listing 2020 events listing BioBridges 2020	Conferences / Workshops	Helmut	2019-09-10 13:33	2	2019-09-10 14:17	136
BA/BE for guidelines for ANVISA in English version ANVISA	Regulatives / Guidelines	Pandu	2019-09-10 05:30	1	2019-09-10 11:25	147
Snake Oil? Snake Oil? Snake Oil?	Off Topic	Helmut	2019-09-09 15:48	2	2019-09-09 17:59	121
PK model parameters IR vs MR PK model parameters IR vs MR PK model parameters IR vs MR PK model parameters IR vs MR PK model parameters IR vs MR Parameter-identifiability? transit compartments... No organs in (Pop)PK	PK / PD	mittyri	2019-09-02 22:15	7	2019-09-08 10:56	289
IS response variations IS response variations	Regulatives / Guidelines	Ohlbe	2019-09-04 19:03	1	2019-09-06 16:21	188
subject inclusion question in replicate design for ANVISA subject inclusion question in replicate design for ANVISA subject inclusion question in replicate design for ANVISA	RSABE / ABEL	Shuanghe	2019-09-04 14:48	2	2019-09-05 14:38	205
China Local BE study waiver China BE study China BE study	Regulatives / Guidelines	Ajit Thorat	2019-08-29 09:26	2	2019-09-04 15:15	329
Intrasubject CV for fed studies Intrasubject CV for fed studies Intrasubject CV for fed studies Intrasubject CV for fed studies	PK / PD	jag009	2019-08-22 14:53	3	2019-09-04 06:32	345
Intrasubject CV for ibuprofen	PK / PD	jag009	2019-09-03 16:09	0		121