Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		60,519
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	347
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	177
Is FDA dissolution database more preferable to product specific FDA BE guidance?	Dissolution / BCS / IVIVC	yuvaneshwari	2019-04-18 11:12	0		104
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	524
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	227
1+1=2 ?	Off Topic	nobody	2019-04-15 09:38	0		118
WHO Questions and Answers: similar biotherapeutic products	BE/BA News	Helmut	2019-04-15 00:25	0		125
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	262
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	313
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	588
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	385
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	440
Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints Sample Size Based on Pharmacodynamic endpoints	Power / Sample Size	sury	2019-04-03 12:28	5	2019-04-05 08:37	359
Possible bug in bootf2BCA Bug in bootf2BCA - Open source rulez!	Software	Shuanghe	2019-04-03 17:41	1	2019-04-03 19:42	261