Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
Ethics comittee	Regulatives / Guidelines	wisdom	2019-04-23 10:43	0		204
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	572
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	383
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	811
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	391
1+1=2 ?	Off Topic	nobody	2019-04-15 09:38	0		235
WHO Questions and Answers: similar biotherapeutic products	BE/BA News	Helmut	2019-04-15 00:25	0		230
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	383
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	462
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	811
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	518
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	538
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	453
Carry-over in pre-dose samples for steady state BE Carry-over in pre-dose samples for steady state BE 5% Cmax-rule only in SD 5% Cmax-rule only in SD Carry-over in pre-dose samples for steady state BE	Study Assessment	hirenpharm	2019-03-29 20:56	4	2019-04-03 02:48	513
Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity?	BE/BA News	mittyri	2019-04-02 12:32	3	2019-04-02 13:37	405