Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		90,959
Informed Consent Document Review Informed Consent Document Review Informed Consent Document Review	Regulatives / Guidelines	suchit_bhavsar	2019-12-11 11:22	2	2019-12-11 19:36	65
Clarification from Russian expert organization regarding telmisartan BE studies Clarification from Russian expert organization… Questions Guesses & answers intergender differences and consequences intergender differences and no consequences Questions Questions Careful Confusion from Russian expert organization Clarification from Russian expert organization regarding telmisartan BE studies	Regulatives / Guidelines	Beholder	2019-11-08 07:51	10	2019-12-10 18:53	975
NDA study for Mexico Cmax ER = Cmax IR ? Cmax ER = Cmax IR - the only option Cmax ER = Cmax IR - the only option Cmax ER = Cmax IR ? Cmax ER = Cmax IR ? Cmax ER = Cmax IR ? Cmax ER = Cmax IR ? Cmax ER = Cmax IR ?	Regulatives / Guidelines	jag009	2019-12-06 16:19	8	2019-12-09 18:15	227
Should those subjects have only one period data be included in BE analysis? No way! But... No way! But... No way! But... No way! But... No way! But... EMA guideline: no way...: EMA guideline: no way...: Slightly off topic, but related :-) Slightly off topic, but related :-) Slightly off topic, but related :-)	Design Issues	ssussu	2019-12-06 10:58	10	2019-12-09 15:13	380
Generic submission in India Dead silence in India Generic submission in India	Regulatives / Guidelines	jag009	2019-11-11 21:43	2	2019-12-09 13:29	1,760
To Russia (with love?) To Russia (with love?) From Russia (with love?) From Russia with review From Russia (with love?) Ignorance is not bliss Ignorance is not bliss Ignorance is not bliss - but this is modus vivendi Ignorance is Strength? So sad! does existence exist? OT: Something and nothing add OT: Everything and Nothing OT: Something and nothing Russian edition OT: Something and nothing Russian edition OT: “Deutscher Humor” OT: “Deutscher Humor” OT: “Deutscher Humor” OT: “Deutscher Humor” OT: Something and nothing	RSABE / ABEL	Helmut	2019-12-04 01:21	19	2019-12-07 21:21	576
Active metabolites: to measure or not to measure Active metabolites: to measure or not to measure Parent only. Chiral assay?	Regulatives / Guidelines	Elena777	2019-12-05 20:34	2	2019-12-06 00:26	145
A stray thought, just one of many	Power / Sample Size	ElMaestro	2019-12-05 18:01	0		75
ICH M13 ICH M13 ICH pushed by GBHI? ICH pushed by GBHI? “Lively” discussions M9 step 4 now published And Japan? And Japan? 🈴 business as usual	BE/BA News	Helmut	2019-11-27 19:08	8	2019-12-04 15:42	655
EMA Q&A vs EMA Product Specific guideline Crushed Rivaroxaban? Crushed Rivaroxaban? specific BE study with administration of crushed/disintegrated tablet	Regulatives / Guidelines	Averroes	2017-10-04 12:01	3	2019-12-03 18:20	3,041
Bio-waiver of Sapropterin dihydrochloride powder for oral solution Please do your homework first Bio-waiver of Sapropterin dihydrochloride powder for oral solution	Dissolution / BCS / IVIVC	AB661	2019-11-22 17:49	2	2019-12-03 17:06	800
Julia: Bioequivalence and Pharmacokinetics packages Congratulations! Thank you so much! OT: I hate software not asking me for the installation path OT: I hate software not asking me for the installation path	Software	PharmCat	2019-12-01 00:06	4	2019-12-02 17:29	276
On CI calculation, untransformed metrics Fieller’s (‘fiducial’) confidence interval Fieller’s (‘fiducial’) confidence interval Fieller’s (‘fiducial’) confidence interval Fieller’s (‘fiducial’) confidence interval power.TOST with logscale=FALSE On CI calculation, untransformed metrics	General Statistics	ElMaestro	2019-11-29 03:40	6	2019-11-30 14:01	522
BLQ handling in BE study where all values in one profile are BLQ BLQ handling in BE study where all values in one profile are BLQ all values in one profile are BLQ (test) BLQ handling in BE study where all values in one profile are BLQ BLQ handling in BE study where all values in one profile are BLQ	NCA / SHAM	Hutchy_7	2019-11-28 15:17	4	2019-11-28 17:44	474