Frank Diana
Articles
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 2014A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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 2012IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
Latest Updated Articles
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: August 21st 2024 | Updated: December 26th 2024
Pharmaceutical Technology Editorial Advisory Board
Published: November 25th 2024 | Updated: December 26th 2024
Leveraging Integrated Patient-Centric Innovations When Developing Today’s Biologics
Published: December 20th 2024 | Updated: December 26th 2024
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Published: February 23rd 2024 | Updated: December 26th 2024
Europa Perspectives: Helping to Navigate the Regulatory System
