Jd. Esinhart et Vm. Chinchilli, SAMPLE-SIZE CONSIDERATIONS FOR ASSESSING INDIVIDUAL BIOEQUIVALENCE BASED ON THE METHOD OF TOLERANCE INTERVALS, International journal of clinical pharmacology and therapeutics, 32(1), 1994, pp. 26-32
This is the consideration of sample sizes for assessing individual bio
equivalence based on the use of tolerance intervals. The sample size p
rocedures discussed include a direct distribution-free method, indirec
t parametric method and a direct parametric method. Design considerati
ons are discussed based on the results of the direct parametric method
. Tables are provided for easy access of results.