GEN

Kinetic Model Outperforms ICH Guidelines for Biologic Stability

Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...
PharmTech

Which Batch Size for Validation and Stability Studies?

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel. Q. We are planning to market a new drug (film coated ...
Labroots

Highlights of the In Vitro Sections of the Draft ICH Drug Interaction Studies M12 Guideline and Comparison with Current Guidance

In June 2022, the ICH released the first draft of its harmonized global Drug Interaction Studies Guideline (M12). The guideline is the result of several meetings of the Expert Working Group since 2018 ...
PharmTech

Stability Studies: An Essential Step for Quality Management in Drug Development

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it. While every drug molecule is unique and brings its own ...
JD Supra

FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product specific guidances to align with ICH M13A BE ...

The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...