Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
ICH M9 - reverse engineering? ICH M9 - reverse engineering? ICH M9 - reverse engineering? ICH M9 - reverse engineering?	MSimoes	2020-09-16 16:01	3	2020-09-30 05:27	4,207
Bioequivalence Limit, Power and interpretation Bioequivalence Limit, Power and interpretation Power and sensitivity analyses	Pharma_88	2020-09-22 13:27	2	2020-09-25 11:42	6,010
Retention for multicenter patient BABE study Retention for multicenter patient BABE study	pash413	2020-09-06 17:43	1	2020-09-14 12:21	4,408
EMA: Waiving MD study EMA: Waiving MD study EMA: Waiving MD study PK model Zero order helps often Zero order helps often Distributed delay	Helmut	2020-09-09 16:21	6	2020-09-11 03:31	7,067
Design Jurisdiction? Jurisdiction? EMA: ABEL for HVD(P)s, PK metrics EMA: ABEL for HVD(P)s, PK metrics EMA: MD PK metrics	Pharma_88	2020-08-27 16:07	5	2020-09-08 15:25	10,929
Document Retention Period for Bioequivalence study Turkish Submission Website of the Turkish Medicines and Medical Devices Agency Document Retention Period for Bioequivalence study Turkish Submission Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? Document Retention Period: ICH = 2 Years, Nigeria = 5 Years, Turkey = ? ICH = 2 Years after last approval based on study	yatish gosai	2020-08-10 14:36	5	2020-09-01 09:03	6,459
bioequivalence of vit D3 cholecalciferol	khaoula	2020-08-18 12:41	0		2,579
long half-life and large variability long half-life and large variability long half-life and large variability long half-life and large variability long half-life and large variability long half-life and large variability long half-life and large variability	martin	2020-07-29 16:57	6	2020-08-12 13:53	6,090
Favipiravir Bioanalysis Homework Homework “Shlonak”	Ayman Rabayah	2020-08-11 08:44	3	2020-08-12 10:57	4,280
USFDA guidance for petitioned ANDA	shahajan baig	2020-07-20 21:50	0		2,137
CDISC in China?	jag009	2020-07-16 19:46	0		1,946
Requirements for different pharmaceutical forms or dosages Homework ;-)	Mauricio Sampaio	2020-07-13 13:52	1	2020-07-13 15:25	3,189
Transdermal	Kelen	2020-06-29 18:51	0		2,409
steady state for modified release steady state for modified release steady state for modified release Superposition principle Superposition principle	Kelen	2019-09-20 20:04	4	2020-06-24 13:32	8,331
AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf ADME-tox? ADME-tox? OT OT OT Science vs. regulations Science vs. regulations ratio = difference of logs! Science vs. (EMA) GL aka PK primer Science vs. regulations Science vs. regulations Science vs. regulations Science vs. regulations AUCt not covering at least 80% of AUCinf AUCt not covering at least 80% of AUCinf So what? Carrot and whip Gedankenexperiment Dead dogs Aber meine Herren das ist keine physik Aber meine Dame, das ist alles Unsinn! Bizarre paper Bizarre paper OT: Bias of AUCt, AUCall, pAUC OT: Bias of AUCt, AUCall, pAUC OT: Bias of AUCs; example Maxwell's demon Dead dogs	ratnakar1811	2013-03-05 08:30	31	2020-06-12 12:15	44,642