Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last Reply	Views
BioBridges 2018 – invitation & preliminary program	Conferences / Workshops	Helmut	2018-07-02 00:30	0		1,298
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		34,858
Spelling out FDA's pop BE model	General Statistics	ElMaestro	2018-08-15 11:02	0		6
Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap Validation of PhEq_bootstrap PhEq_bootstrap in R	Software	Helmut	2018-07-12 17:47	7	2018-08-15 09:45	608
Sampling time Sampling time Sampling time	Design Issues	drp	2018-08-10 07:09	2	2018-08-14 07:37	219
2019 events listing	Conferences / Workshops	Helmut	2018-08-13 13:54	0		73
Phoenix Connect Phoenix’ History-tab ≠ audit trail	Software	NK	2018-08-10 10:43	1	2018-08-10 11:11	160
FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA	BE/BA News	Helmut	2018-08-09 10:52	0		139
Repeat based on ISR data investigation	Bioanalytics	Mithu	2018-08-08 10:09	0		151
> 5% of Cmax for endogenous molecule? Any own thoughts? carryover effect in endogenous substances	Regulatives / Guidelines	Ramesh Ramalingam	2018-06-18 08:00	2	2018-08-08 07:29	569
Dose-proportionality versus dose-linearity Dose-proportionality versus dose-linearity Dose-proportionality versus dose-linearity Dose-proportionality versus dose-linearity	PK / PD	martin	2018-08-03 10:25	3	2018-08-07 13:04	1,945
Lower bound for power of two combined TOST? Lower bound for power of two combined TOST? Lower bound for power of two combined TOST? Appendix D Appendix D Use of lower bound for power of two combined TOST Use of lower bound for power of two combined TOST Use of lower bound for power of two combined TOST	Power / Sample Size	d_labes	2018-07-25 10:40	7	2018-08-07 11:50	459
BE criteria BE criteria	Regulatives / Guidelines	rajasekharkakarla	2018-08-03 09:21	1	2018-08-06 20:35	2,147
EMA: Q&A Update EMA: Q&A Update The early bird gets the worm The early bird gets the worm but Lambda Therapeutic Ltd.? Lambda Therapeutic Ltd.? EMA: Q&A Update; Expected studies for Quetiapine PR Tablets	BE/BA News	Helmut	2013-11-15 13:53	6	2018-08-06 14:42	6,785
EMA: 2 product-specific guidances adopted EMA: New product-specific draft guidances published EMA: New product-specific draft guidance published EMA: 5 product-specific guidances adopted	BE/BA News	Helmut	2018-06-26 14:40	3	2018-08-03 16:52	975
New FDA BMV guideline What a monster! What a monster! Two Versions: May 21 & May 24 Repeats as part of investigations, ja oder nein? Repeats as part of investigations, ja oder nein? Two Versions: May 21 & May 24 Requirements ⇒ recommendations Requirements ⇒ recommendations	BE/BA News	Ohlbe	2018-05-21 16:28	8	2018-08-02 22:59	1,287

Bioequivalence and Bioavailability Forum 12:42 CEST