In vitro-In vivo Relationship and Bioequivalence Prediction for Modified-Release Capsules Based on a PBPK Absorption Model.

A physiologically based pharmacokinetic (PBPK) absorption model was developed in GastroPlus™ based on data on intravenous, immediate-release (IR), and modified-release (MR) drug products. The predictability of the model was evaluated by comparing predicted and observed plasma concentration profiles; average prediction errors (PE) were below 10%. IVIVR was developed using mechanistic deconvolution for a MR drug product to evaluate the in vivo effect of a proposed change in dissolution specification.

Efficacy of Calcipotriol-Betamethasone Ointment in Patients with Mild to Moderate Plaque Psoriasis: Subgroup Analyses.

Background: Several factors have been shown to affect psoriasis pathogenesis, clinical presentation and treatment response.

Objectives: The aim of this study was to investigate the potential relationship between patients' baseline characteristics and the efficacy of calcipotriol-betamethasone ointment in patients with mild to moderate plaque psoriasis and to evaluate whether the efficacy is consistent across subgroups.

Method: Using data from the therapeutic equivalence study on patients with plaque psoriasis, post hoc analyses were performed to evaluate the impact of baseline demographic and disease characteristics, habits and comorbidities on the response to treatment with calcipotriol-betamethasone ointment.