Dissolution testing is trending toward data integrity solutions and more biorelevant testing techniques.

Advances in Dissolution Testing

Effective cleaning and disinfection along with contamination controls is imperative when operating and utilizing a cleanroom.

Cleanroom Cleaning: Proper Methodology and Determining Efficacy

Automated analytical workflows generate higher data output.

Higher Data Output Poses Management Challenges

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Articles

Aizon Digitize is designed to help life science manufacturers transition data from paper to digital.

Aizon Launches GxP Compliant Data Processing Solution

Avid Bioservices has expanded its viral vector development and manufacturing facility with the addition of analytical and process development suites.

Avid Bioservices Launches New Analytical and Process Development Suites at Viral Vector Facility

Bio-Rad’s SEQuoia Express Stranded RNA Library Prep Kit is designed to construct efficient RNA sequencing workflows.

Bio-Rad Launches SEQuoia Express Stranded RNA Library Prep Kit

Axol Bioscience’s CiPA-validated ventricular cardiomyocytes can be used as a robust cardiotoxicity measurement tool.

Axol Bioscience Announces CiPA-Validated Human Stem Cell-Derived Ventricular Cardiomyocytes

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Ashvin Patel, PhD, is the director of Analytical Research & Business Development, Teledyne Hanson Research, New York, USA.

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

Editor of Pharmaceutical Technology Europe

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

Ensuring Patient Safety Through Elemental Impurity Analysis

Amy Lavelle is associate director at Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific.

Laura Brunner is principal scientist at Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

When Is It Appropriate to Outsource Bioanalysis Work to a CRO?

BioRad Laboratories CFX Duet System is designed to help researchers develop singleplex and duplex quantitative polymerase chain reaction assays.

Bio-Rad Launches CFX Duet Real-Time PCR System

Grant Playter is the Assistant Editor for 

Dissolution testing has seen recent trends that have led to increased data integrity solutions as well as an increase in biorelevant testing techniques.

Dissolution Testing Sees Advances

Chris Spivey is the editorial director of 

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

Analytics

Advances in Dissolution Testing

Cleanroom Cleaning: Proper Methodology and Determining Efficacy

Higher Data Output Poses Management Challenges