In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

Analytical methods aimed at isolating, identifying, and characterizing components within complex biological samples, such as ...

Good HPLC methods must satisfy both technical requirements (sensitivity, specificity, linearity, accuracy and precision) as well as business needs (reliability in routine use and a run time ...

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma today announced the launch of its new Analytical Services offering that provides analytical testing and stability services to pharmaceutical developers ...

Usage: Reference standards serve as quality control benchmarks for equipment calibration and verification of measurement methods and analytical accuracy. Characteristics: Chemicals with established ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Since 2007, guidelines from the European Medicines Agency and a draft version from the U.S. Food & Drug Administration have called on the drug industry to reduce DNA-reactive genotoxic impurities ...