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 ...

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 ...

This field has evolved considerably through the integration of systematic design strategies, notably the incorporation of Analytical Quality by Design (AQbD) principles and robust statistical tools ...

Michael Rooney, director, bioanalytical development at Jazz Pharmaceuticals, provides an overview of a life cycle strategy for analytical methods development, the need for standards and guidance ...

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods. About a decade ago, FDA and other regulatory agencies introduced a series of ...

In the pharmaceutical industries, validation of analytical methods is a critical process that confirms the reliability and appropriateness of a method for its intended application. Method validation ...

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

Monique Paré Speirs is a researcher and method developer for Rhyz Analytical Labs (a Nu Skin company), a QC testing lab for raw materials, dietary supplements, cosmetics, and personal care products.

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 ...