Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		36,198
BCS Based Biowaiver application Price?	Dissolution / BCS / IVIVC	joosefupas	2018-10-19 14:54	0		92
Little thing which changes almost everything in EEU LLOQ ≤5% of expected or observed Cmax? LLOQ ≤5% of average or minimal Cmax? LLOQ ≤5% of individual Cmax-values LLOQ ≤5% of individual Cmax-values An outlier?	Bioanalytics	Beholder	2018-10-18 09:08	5	2018-10-19 09:43	221
Quality System	GxP / QC / QA	vishal1721	2018-10-19 09:29	0		83
Virtual Bioequivalence: a myth or coming reality? Virtual Bioequivalence: a myth or coming reality? Virtual Bioequivalence: a myth or coming reality?	Dissolution / BCS / IVIVC	mittyri	2018-06-09 22:39	2	2018-10-19 01:17	786
Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals First hints for Phoenix Phoenix: residuals Phoenix: residuals Phoenix: residuals Phoenix: residuals Software validation Software validation Avoid raw residuals Avoid raw residuals Phoenix → R Phoenix → R Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals Qualitative analysis of the ANOVA residuals	General Statistics	Lucas	2014-02-19 14:27	20	2018-10-18 18:05	9,152
BioBridges slides? BioBridges slides? BioBridges slides? BioBridges slides? BioBridges slides BioBridges slides 2018 BioBridges slides 2018	Conferences / Workshops	ElMaestro	2017-09-29 10:41	6	2018-10-18 11:21	3,221
FDA: Size of bio-batch FDA: Size of bio-batch FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 FDA: antique of ’93 Patience FDA: antique of ’93 Nice numbers Nice numbers Type II variation Birdsong's third law of BE Experience Why, oh why? Sorry for the delay	Regulatives / Guidelines	Helmut	2013-12-10 14:05	16	2018-10-18 09:40	5,031
Theophylline ER 450 mg study design	Design Issues	Ramesh Ramalingam	2018-10-18 07:16	0		78
Reference drug product for Captopril / Hydrochlorothiazide	Design Issues	A-M-R	2018-10-17 14:46	0		84
Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays)	Design Issues	Mikalai	2018-10-16 13:42	3	2018-10-17 11:56	183
Power is getting high Power is getting high? Stop estimating post hoc power! Stop estimating post hoc power! Stop estimating post hoc power! Simulations Simulations Simulations Simulations Simulations Simulations α and 1–β α and 1–β α and 1–β α and 1–β Educate the IEC and regulators “Forced BE” 101 “Forced BE” 101 Would you be so kind answering our questions? Would you be so kind answering our questions? Yes, but why? Yes, but why? Optimists and pessimists "normal" GMR setting Example for discussion Example for discussion I prefer to play it safe Full ACK About GMR 1.10 Better 0.95 or 0.90 Yes, but why? Buffon's needle Buffon's needle 0.95 or 1.05 Buffon's needle Buffon's needle School maths School russian Offtop: Umschrift der westlichen Eigennamen auf Russisch EEU? EEU? EEU - pharmacokinetic equation??? EEU? Simulations Numbers don't lie	Power / Sample Size	kms.srinivas	2017-12-26 07:39	44	2018-10-12 23:25	10,461
Enoxaparin sodium injection BA BE studies BE of parenterals Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies Enoxaparin sodium injection BA BE studies	Regulatives / Guidelines	varsha chungde	2018-10-08 11:34	5	2018-10-10 07:11	370
How to prepare QC for endogenous molecule How to prepare QC for endogenous molecule	Bioanalytics	chandru	2018-09-10 17:33	1	2018-10-10 03:20	262
All animals are equal, but some animals are more equal than others	BE/BA News	Helmut	2018-10-09 14:33	0		212
Redesign of the EMA’s website	BE/BA News	Helmut	2018-10-08 12:20	0		230

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