Brent Kleintop

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Perspectives on Quality Attributes of Drug Products Containing Nanomaterials

Perspectives on Quality Attributes of Drug Products Containing Nanomaterials

Kahkashan Zaidi, PhD;Brent Kleintop;John Hammond;Nancy Lewen;Emmanuel Akala;Anthony Hickey;Jolyon Mitchell;June Liang;Timothy Shelbourn;Katherine Tyner;Eloise Welfare;Norbert Maurer;Munir Hussain;Lawrence Block;Myke Scoggins;Thomas Tice
October 1st 2019

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

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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GMPs for Small-Molecule Drugs in Early Development (Part I)

Tony Mazzeo;Amnon Eylath;John W. Skoug;Brent Kleintop;Andy Rignall;James S. McElvain
June 2nd 2012

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

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