(This article belongs to the Special Issue Maximising Drug Delivery for Improved Pharmacokinetics and Pharmacodynamics ) Early Stage Preclinical ...
Dear AAPS members – I recently saw a funny meme that called the month of January "just one never-ending Monday." While I can understand the sentiment, ...
E2B(R3) - Information Paper and Implementation Guide Package aligning individual case safety reporting with the updated E2D Guideline M4Q(R2) ...
From the e-mail announcement: "Today, after several months of collaboration, the FDA and the European Medicines Agency (EMA) are releasing a common set ...
FDA released today a new draft guidance on "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products" and is accepting comments until ...