April 5th 2025
The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
Risk-Based Predictive Stability–An Industry Perspective
A survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Establishing Blend Uniformity Acceptance Criteria for Oral Solid-Dosage Forms
February 2nd 2017This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.