Methylphenidate extended-release (ER) products are used in the treatment of attention-deficit/hyperactivity disorder (ADHD). These products exhibit diverse pharmacokinetic (PK) profiles that influence early systemic exposure and clinical response. To ensure bioequivalence (BE) for products such as Concerta and Ritalin LA, both the FDA and EMA recommend the use of pAUC(0-3h), with the EMA additionally suggesting the inclusion of C(max,0-3h). However, it remains unclear whether C(max,0-3h) offers…
