Mark D. Trone

home / authors / mark-d-trone

Articles

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.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: October 28th 2024 | Updated: November 21st 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 21st 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 21st 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com
Published: November 8th 2024 | Updated: November 21st 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification