Science is a cruel mistress [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2015-07-28 16:31 (3484 d 02:44 ago) – Posting: # 15164
Views: 4,749

Hi Anand,

❝ Why drug having highly variable […] any specific reason?


A manifold of reasons:
In the context of BE: If high variability is to a larger extent related to the formulation and you are thinking about reference-scaling I would suggest a pilot study in a fully replicated design (RTRT|TRTR or RTR|TRT). If CVwT < CVwR you will get a reward in the required sample size of the pivotal study. Try this in [image]:

library(PowerTOST)
CV <- 0.4
# FDA
sampleN.RSABE(CV=CV, theta0=0.9, design="2x2x4", details=F)
sampleN.RSABE(CV=CVp2CV(CV=CV, ratio=0.67), theta0=0.9, design="2x2x4", details=F)
# EMA
sampleN.scABEL(CV=CV, theta0=0.9, design="2x2x4", details=F)
sampleN.scABEL(CV=CVp2CV(CV=CV, ratio=0.67), theta0=0.9, design="2x2x4", details=F)



  1. Wu C-Y, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and develop­ment of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11–23. doi:10.1007/s11095-004-9004-4.
  2. Benet LZ, Broccatelli F, Oprea TI. BDDCS Applied to Over 900 Drugs. AAPS J. 2011;13(4):519–47. doi:10.1208/s12248-011-9290-9. [image] free resource


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