Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		60,923
Ethics comittee	Regulatives / Guidelines	wisdom	2019-04-23 10:43	0		15
R code for analysis of data from partial replicate design "2x3x3" BE study R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL R code for the EMA’s ABEL package replicateBE for R	R for BE/BA	mahmoud-teaima	2017-06-08 17:45	11	2019-04-22 18:46	9,739
Expiration of Reference drug during Bioanalysis Expiration of Reference drug during Bioanalysis Expiration of Reference drug during Bioanalysis Expiration of Reference drug during Bioanalysis Expiration of Reference drug during Bioanalysis Expiration of Reference drug during Bioanalysis OT: Regulatory persons	Bioanalytics	wienui	2019-04-14 11:51	6	2019-04-20 20:46	398
SAS code for the mixed effects model with sequence mistakenly assigned Failure in randomization Real sensitivity What is your root cause?	Study Assessment	libaiyi	2019-04-19 09:32	3	2019-04-19 16:19	228
Is FDA dissolution database more preferable to product specific FDA BE guidance?	Dissolution / BCS / IVIVC	yuvaneshwari	2019-04-18 11:12	0		134
Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Metrics for absorption Simulation framework Simulation framework Conclusion Conclusion & beyond	NCA / SHAM	Helmut	2019-04-15 12:08	14	2019-04-17 17:05	560
Non-inferiority Sample Size Estimation Non-inferiority Sample Size Estimation Non-inferiority Sample Size Estimation Read, read, read!	Power / Sample Size	sury	2019-04-16 08:44	3	2019-04-17 10:59	249
1+1=2 ?	Off Topic	nobody	2019-04-15 09:38	0		129
WHO Questions and Answers: similar biotherapeutic products	BE/BA News	Helmut	2019-04-15 00:25	0		135
Tmax in three treatment, three period, three sequence design Tmax in three treatment, three period, three sequence design Going beyond two periods	Nonparametrics	libaiyi	2019-04-09 07:15	2	2019-04-12 19:14	276
Sample Shipment (dry ice) ☣ Sample Shipment (dry ice) ☣ Sample Shipment (dry ice) ☣ Satisfaction? Satisfaction?	GxP / QC / QA	Helmut	2019-04-10 15:03	4	2019-04-12 18:59	336
Storage conditions of plasma samples Storage conditions of plasma samples OT: Free access to the AAPS J OT: Free access to the AAPS J OT: Free access to the AAPS J Forum internal: ★ Forum internal: ★ Forum internal: ★ Forum internal: ★ Forum internal: ★ Forum internal: ★ Unique statuses Unique statuses Unique statuses Storage conditions of plasma samples	Bioanalytics	Erol	2019-04-09 11:51	14	2019-04-12 10:43	619
Clinical Endpoint Bioequivalence study Clinical Endpoint Bioequivalence study Clinical Endpoint Bioequivalence study Scores	Regulatives / Guidelines	sury	2019-04-08 13:29	3	2019-04-09 06:19	403
Clinical end point acceptance limit Clinical end point acceptance limit Clinical end point acceptance limit Clinical end point acceptance limit –0.2025 < –0.2, right?	Study Assessment	PKS	2019-04-05 08:45	4	2019-04-05 10:53	451