Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products Generic vs. hybrid	Regulatives / Guidelines	Mikkabel	2024-11-20 09:00	6	2024-11-22 13:17	2,561
Baseline correction vs non-baseline correction Baseline correction vs non-baseline correction Baseline correction vs non-baseline correction Baseline correction or supra-therapeutic dose Baseline correction or supra-therapeutic dose Baseline profile prior to each period? Baseline correction examples Baseline correction examples Baseline correction examples Baseline correction examples Baseline correction examples Postmenopausal women Baseline correction examples Baseline correction examples Postmenopausal women Postmenopausal women Baseline correction examples Baseline correction GeoMean and Median Geometric mean? Geometric mean? Geometric mean ≈ MLE of median Geometric mean ≈ MLE of median Bias? Bias? Baseline; another example Baseline; another example Baseline; another example Baseline; another example Slowly going OT: BE study simulations Slowly going OT: BE study simulations Religious debate Religious debate Religious debate Religious debate Slowly going OT: BE study simulations Slowly going OT: BE study simulations Slowly going OT: BE study simulations Business as usual Business as usual	Regulatives / Guidelines	jag009	2015-09-15 20:29	38	2024-11-16 11:12	26,195
reason to exclude volunteer FDC: No measurable concentrations of one drug FDC: No measurable concentrations of one drug	Study Assessment	Loky do	2024-11-10 11:52	2	2024-11-10 12:48	1,508
Calculating 90% CIs in R vs Python	Software	Dorota_	2024-11-08 18:35	0		1,032
‘alpha’ of scaled ABE? ‘alpha’ of scaled ABE? ’alpha’ of scaled ABE: design N=24, 48 adaptive design without adjustment α adjustment? iteratively adjusted alpha throw away our sample size tables? if real regulators don’t care? adjusting α missing letter PowerTOST: sampleN.scABEL.ad() PowerTOST: sampleN.scABEL.ad() Molins et al. (2017) target α in sim’s? target α in sim’s? If it is real: results having alpha fixed swr fixed swr Yes but no but yes but no but…	RSABE / ABEL	d_labes	2013-03-15 15:56	21	2024-11-08 14:34	31,235
Shipment of Investigational Medicinal products Shipment of Investigational Medicinal products Shipment of Investigational Medicinal products	Regulatives / Guidelines	qualityassurance	2024-10-30 13:47	2	2024-11-06 14:15	1,655
Reanalysis reason Daylight saving time Daylight saving time	Bioanalytics	Loky do	2024-11-04 11:15	2	2024-11-04 15:37	1,500
FDA: Update of PSGs to align with ICH M13A FDA: ICH M13A, Q&A, PSGs, and a rant	Regulatives / Guidelines	Helmut	2024-10-03 15:58	1	2024-11-01 08:58	2,388
PK Sampling Time Points - SR Formulation PK Sampling Time Points - SR Formulation PK Sampling Time Points - SR Formulation PK Sampling Time Points - DR Formulation PK Sampling Time Points - DR Formulation lag-time – another round	Design Issues	TitusBen	2024-10-17 05:40	5	2024-10-19 08:20	2,533
Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies Question about computing 90% CI w data from 2 separate studies	General Statistics	jag009	2024-10-14 01:44	6	2024-10-18 12:03	2,334
Bioequivalence centre and In vitro (formulation lab)	Dissolution / BCS / IVIVC	ryraman2661	2024-10-18 11:14	0		1,010
Sulfasalazine: Bioequivalence Study Sulfasalazine: Bioequivalence Study Sulfasalazine: Bioequivalence Study Sulfasalazine: Sources Sulfasalazine: Sources	Design Issues	ramesh_7779	2011-06-25 10:54	4	2024-10-16 06:16	6,463
"Dose or Strength to be Studied" in ICH M13A "Dose or Strength to be Studied" in ICH M13A "Dose or Strength to be Studied" in ICH M13A	Regulatives / Guidelines	Darborn	2024-09-30 01:14	2	2024-10-08 00:58	1,923
Draft guideline on quality and equivalence of topical products – still stuck? Patience… MWP Final & published	Regulatives / Guidelines	mittyri	2024-09-14 20:24	3	2024-10-03 11:44	2,164
EMA: GL on quality and equivalence of LALA cutaneous products	BE/BA News	Helmut	2024-10-03 11:41	0		1,232