May 7th 2025
This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
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.