Global geoepidemiology of gastrointestinal surgery rates in Crohn's disease.

Background: Data regarding the worldwide gastrointestinal surgery rates in patients with Crohn's disease (CD) remains limited.

Aim: To systematically review the global variation in the rates of surgery in CD.

Methods: A comprehensive search analysis was performed using multiple electronic databases from inception through July 1, 2020, to identify all full text, randomized controlled trials and cohort studies pertaining to gastrointestinal surgery rates in adult patients with CD.

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series.

A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scientists, together with regulatory and academic scientists, came together through a series of six webinars, to discuss progress in the field, emerging trends, and areas for continued collaboration and harmonisation. Each webinar also hosted a Q&A session where participants could discuss the shared topic and information.

The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.

The use of physiologically based pharmacokinetic (PBPK) modeling to support the drug product quality attributes, also known as physiologically based biopharmaceutics modeling (PBBM) is an evolving field and the interest in using PBBM is increasing. The US-FDA has emphasized on the use of patient centric quality standards and clinically relevant drug product specifications over the years. Establishing an in vitro in vivo link is an important step towards achieving the goal of patient centric quality standard.

Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.

This report summarizes podium presentations and breakout sessions from the second day of the 2019 M-CERSI workshop on In Vitro Dissolution Similarity Assessment in Support of Drug Product Quality: What, How, and When? Presenters from the U.S. Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA), Brazilian Health Surveillance Agency (ANVISA), and the pharmaceutical industry shared experiences/concerns with dissolution profile similarity assessment supporting minor/moderate Chemistry, Manufacturing and Control (CMC) changes.

Understanding In Vivo Dissolution of Immediate Release (IR) Solid Oral Drug Products Containing Weak Acid BCS Class 2 (BCS Class 2a) Drugs.

In vivo drug dissolution kinetics of BCS Class 2a IR solid oral drug products remains largely unknown. An understanding to what extent the solubility influences in vivo dissolution is needed to design appropriate in vitro dissolution methods. In this study, nonsteroidal anti-inflammatory drugs (NSAIDs) are used to investigate the in vivo dissolution of BCS Class 2a drugs based on numerical deconvolution analyses.