Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		134,502
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 bootf2BCA v1.2 bootf2BCA v1.2: seed bootf2BCA v1.2: seed Which packages, working drectory?	Software	Helmut	2018-07-12 17:47	11	2021-04-16 10:50	8,701
Retention samples Retention samples	Regulatives / Guidelines	vinodvasala	2021-04-13 13:27	1	2021-04-13 19:07	1,211
Cataplasms and study design	Regulatives / Guidelines	Pharma_88	2021-04-13 06:31	0		102
WHO guideline on data integrity	Regulatives / Guidelines	Ohlbe	2021-04-08 11:03	0		192
New software for PK analysis - PKMP. Any good ? New software for PK analysis - PKMP. Any good ?	Software	WhiteCoatWriter	2021-04-02 06:37	1	2021-04-08 05:42	471
ICH GCP type of the data ICH GCP type of the data	GxP / QC / QA	Beholder	2021-04-05 11:56	1	2021-04-05 21:35	316
Exclusion due to adverse event State it in the SAP & observe it Exclusion due to adverse event	Design Issues	Loky do	2021-03-29 15:59	2	2021-03-31 14:43	792
BE study designing related doubts BE study designing related doubts	Design Issues	gsrao2022	2021-03-28 20:12	1	2021-03-29 00:41	358
Regulations about bioequivalence studies in Turkey Regulations about bioequivalence studies in Turkey Regulations about bioequivalence studies in Turkey	Regulatives / Guidelines	Mohamed Yehia	2021-02-22 17:32	2	2021-03-28 16:36	459
Why is just Cmax out of specification? AUC passes, Cmax fails: biopharmaceutical difference AUC passes, Cmax fails: biopharmaceutical difference	PK / PD	akif	2021-03-22 20:36	2	2021-03-24 16:59	416
Regulatory Submission in Europe in Absence of Reference product Regulatory Submission in Europe in Absence of Reference product Regulatory Submission in Europe in Absence of Reference product	Regulatives / Guidelines	Abhay Patil	2021-03-23 08:58	2	2021-03-23 10:00	359
Question raised by the PMDA Question raised by the PMDA Question raised by the PMDA	Design Issues	Helmut	2021-02-26 15:46	2	2021-03-19 18:06	733
List of reference drug List of reference drug List of reference drug	Study Performance	Elzbieta	2021-03-15 19:56	2	2021-03-16 16:33	450
higher order crossover methodology All dosed subjects have to be analyzed All dosed subjects have to be analyzed All dosed subjects have to be analyzed All dosed subjects have to be analyzed higher order crossover methodology higher order crossover methodology higher order crossover methodology Fed (IBD) → fasting Fed (IBD) → fasting	General Statistics	sweiner	2020-06-30 01:07	9	2021-03-16 16:00	3,024