Mark D. Trone

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Evaluating Progress in Analytical Quality by Design

Evaluating Progress in Analytical Quality by Design

Elizabeth Hewitt;Andy Rignall;Mark D. Trone;Patrick Jackson;Marion Chatfield;Mark Argentine;Qinggang Wang;Shreekant Karmarkar;Andrea M. Pless;Zeena Williams;Kimber Barnett;David Semin;Yanqun Zhao;Ariane Marolewski
April 2nd 2017

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

Part VII GMPs for Small Molecule Drugs in Early Development Workshop Summary

Part VII GMPs for Small Molecule Drugs in Early Development Workshop Summary

Q. Chan Li;Mark D. Trone;Jackson Pellett;Michael Szulc;Kirby Wong-Moon
December 2nd 2014

The authors explore and define common industry approaches and practices when applying GMPs in early development.

GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VI

GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VI

Q. Chan Li;Mark D. Trone;Jackson Pellett;Michael Szulc;Kirby Wong-Moon
November 2nd 2014

The authors explore and define common industry approaches and practices when applying GMPs in early development.

Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)

Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)

Dennis O'Connor;James S. McElvain;Mark D. Trone;Michael Coutant;Michael Szulc;Mehran Yazdanian;Shuhong Zhang;Scott A. Miller;Peter Yehl;Kirby Wong-Moon;Zhihong Ge;Frank Swanek
October 2nd 2012

IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.

GMPs for Method Validation in Early Development: An Industry Perspective (Part II)

GMPs for Method Validation in Early Development: An Industry Perspective (Part II)

Brent Kleintop;Mark D. Trone;Michael Szulc;Donald Chambers;Kristin Patterson;Gary Guo;Henrik Rasmussen;Steve Deegan;John Spicuzza;Steven Nowak;Zhanna Yuabova;Karla Tombaugh
July 2nd 2012

IQ Consortium representatives explore industry approaches for applying GMPs in early development.

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