Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		96,243
Sample size calculations Sample size calculations	Power / Sample Size	GM	2020-01-17 13:42	1	2020-01-18 01:31	95
Steady State Bioequivalence Study Pre-dose samples	Design Issues	Pharma_88	2020-01-08 10:07	1	2020-01-09 12:36	325
3+3 Design 3+3 Design 3+3 Design Subject replacement Dose escalation and DMC Dose escalation and DMC	Design Issues	Pharma_88	2020-01-07 08:09	5	2020-01-08 10:41	329
The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time The same PI for two studies in the same time	Study Assessment	wienui	2020-01-05 18:22	4	2020-01-06 13:34	334
Run R-packages in the browser Run R-packages in the browser Run R-packages in the browser Run R-packages in the browser	R for BE/BA	Helmut	2019-12-20 11:17	3	2019-12-20 21:49	555
Significance of Ctau,ss in steady state study Relevance of Cτ,ss	Regulatives / Guidelines	Biostats	2019-12-20 07:51	1	2019-12-20 12:46	470
BEQ inquiry from health authority BEQ inquiry from health authority Method not sensitive enough Revalidation? Revalidation? Method not sensitive enough Method not sensitive enough Method not sensitive enough	Study Assessment	Aymanmy	2019-12-18 08:51	7	2019-12-19 08:21	700
biowaiver requirement for APAC (Asia Pacific)	Regulatives / Guidelines	jag009	2019-12-18 04:45	0		406
Possible Excel bug? Possible Excel bug? Possible Excel bug? Possible Excel bug? M$: It’s not a bug, it’s a feature! M$: It’s not a bug, it’s a feature! M$: It’s not a bug, it’s a feature!	Software	Shuanghe	2019-12-17 13:01	6	2019-12-17 16:00	589
Normal Reference Range Vs Pre-defined site normal values Normal Reference Range Vs Pre-defined site normal values Hb level OT Hb level Hb level Hb level Hb level Hb level Participation databases Participation databases Participation databases Participation databases Participation databases Participation databases National databases‽ Great discussion Great discussion Great discussion WTF 😡 Great discussion National databases‽	Design Issues	cakhatri	2019-12-17 11:35	21	2020-01-02 18:42	1,212
NTI drug but with high CV NTI drug with high CV?	Power / Sample Size	Mikalai	2019-12-14 15:39	1	2019-12-14 16:11	568
BE study design issue 1×2 ≠ 2×1 1×2 ≠ 2×1 1×2 ≠ 2×1 x ◦ y = y ◦ x? BE study design issue ER vs. IR ER vs. IR	Design Issues	jag009	2019-12-13 23:26	7	2019-12-19 09:01	781
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	619
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	745