Frank Diana

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Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

Frank Diana;Jeff Hofer;Marion Chatfield;Nancy Benz;Yuan Huang;Mark Argentine;Qinggang Wang;Shreekant Karmarkar;Hafez Abdel-Kader;Lakshmy M. Nair;Hui Fang;Theresa Natishan;Andrea M. Pless;Rick Burdick;Zeena Williams
October 2nd 2014

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Early Development GMPs for Stability (Part IV)

Early Development GMPs for Stability (Part IV)

Q. Chan Li;Z. Jane Li;Tony Mazzeo;Robert Timpano;Mark Alasandro;Stephen Colgan;Andy Rignall;Z. Jessica Tan;Frank Diana;Bruce Acken;Paul Curry
September 2nd 2012

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.

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