Conducting bioequivalence trials under traditional crossover study designs without exposing
a large number of healthy volunteers to demonstrate two highly variable (% coefficient of …

Background: Bioequivalence studies are pivotal in drug development, ensuring that generic
drug products are equivalent to their reference counterparts. A review of the diverse …

Introduction It is widely believed that acceptable bioequivalence studies of drugs with high
within-subject pharmacokinetic variability must enroll higher numbers of subjects than …

The current drug development framework grants the innovator companies the opportunity to
market a new drug exclusively for a defined time period under patent protection. After the …

Different regulatory agencies provide criteria for selecting a reference product for
bioequivalence (BE) studies. In most cases, the criteria vary from one regulatory agency to …

Pharmacokinetic differences between manufacturing batches, well established for inhaled
drug products, preclude control of patient risk in the customary two-way (single batch) …

Because bioequivalence studies are performed using a crossover design, information on the
intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed …

Because bioequivalence studies are performed using a crossover design, information on the
intra-subject coefficient of variation (intra-CV) for pharmacokinetic measures is needed …

Purpose: Over the last 15 years, an ever-increasing proportion of pharmacokinetic
bioequivalence studies for European/North American generic submissions appeared to …

In 2008, the European Agency for the Evaluation of Medicinal Products released a draft
guidance on the investigation of bioequivalence for immediate release dosage forms with …