Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		102,203
Non-aqueous solutions	Regulatives / Guidelines	The Outlaw Torn	2020-02-24 08:58	0		94
Russia: Changed procedure for determining drug interchangeability Russia: Changed procedure for determining drug interchangeability	BE/BA News	Helmut	2020-02-21 13:20	1	2020-02-21 15:05	139
Pediatric study for a combination product	Regulatives / Guidelines	jag009	2020-02-20 19:59	0		82
Orange or citrus flavor Orange or citrus flavor Orange or citrus flavor Orange or citrus flavor	Regulatives / Guidelines	Dr_Dan	2020-02-20 09:01	3	2020-02-20 12:24	221
ANVISA guidelines for two-stage design Brainless copy-and-paste-devil Brainless copy-and-paste-devil ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design ANVISA guidelines for two-stage design crap crap crap crap Explained crap remains crap Proposed changes Proposed changes	Two-Stage / GS Designs	Mauricio Sampaio	2020-02-11 20:52	15	2020-02-17 14:16	1,438
clinicaltrials registration clinicaltrials registration clinicaltrials registration	Regulatives / Guidelines	powell	2020-02-10 05:36	2	2020-02-13 10:00	292
Route of administration other than oral for concomitant medication Route of administration other than oral for concomitant medication Route of administration other than oral for concomitant medication Route of administration other than oral for concomitant medication	Bioanalytics	qualityassurance	2020-02-04 11:28	3	2020-02-11 16:20	634
ANOVA MODEL No random effects in ANOVA No random effects in ANOVA	General Statistics	abhimanyu	2020-02-04 05:31	2	2020-02-05 12:47	855
Study which captures SD and SS PK Profiles A vs B A vs B ANDA or NDA? Modelling Modelling Modelling: SD+SS	Design Issues	jag009	2020-02-03 20:15	6	2020-02-04 12:38	832
Glycopyrrolate BCS Class Glycopyrrolate BCS Class	Dissolution / BCS / IVIVC	AB661	2020-01-29 10:12	1	2020-02-04 23:17	461
EMA: What do I need if I want to run an overdose study EMA: What do I need if I want to run an overdose study EMA: What do I need if I want to run an overdose study Can of worms Can of worms Can of worms Can of worms EMA: What do I need if I want to run an overdose study EMA: What do I need if I want to run an overdose study	Regulatives / Guidelines	jag009	2020-01-28 20:12	8	2020-02-03 20:34	1,309
Statistical evaluation and BE hypotheses in full replicate design Inflation of the TIE as well Inflation of the TIE as well Tricky… Tricky… Terrible… Tricky… Deep shit Deep shit Deep shit Deep shit Deep shit Deep shit Deep shit Flawed evaluation accepted Flawed evaluation accepted Flawed evaluation accepted Flawed evaluation accepted Flawed approach even if accepted 😡 Flawed approach even if accepted 😡 misunderstanding misunderstanding misunderstanding The globe is flat! Tricky… Tricky… Tricky… ABE vs. ABEL zigzag zigzag zigzag helter-skelter helter-skelter Inflation of the TIE as well Inflation of the TIE as well Statistical evaluation and BE hypotheses in full replicate design	RSABE / ABEL	Elena777	2020-01-28 07:02	35	2020-02-10 16:10	5,860
Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission	Regulatives / Guidelines	Biostats	2020-01-24 08:19	0		714
Higher-order crossovers Purpose of the study? Higher-order crossovers	Power / Sample Size	sweiner	2020-01-22 20:22	2	2020-01-26 16:50	970