EDITORIAL
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Regulatory Sourcebook March 2021
QUALITY
4 Can FDA Reinvent On-Site Inspections?
Agnes Shanley
6 FDA 2021 Guidance Agenda
Sees Focus on Generics
Susan Haigney
OPERATIONS
10 A Real-World Approach to
Evaluating Cleanroom Garments
Anne Marie Dixon-Heathman
QUALITY COLLABORATION
22 Special Section:
It Takes a Bio/Pharma Village
The editors of Pharmaceutical Technology
24 Enabling the Virtual Human Through
Physiologically-based Pharmacokinetic Modeling
Heidi J. Einolf, Stephen D. Hall, Tracy Williams, Aarti Patel,
Christopher Gibson, Nancy G.B. Agrawal, and Jens Sydor
28 Managing the Risk of Nitrosamine Impurities
Timothy Curran and J.P. Bercu
36 Overcoming Challenges to Biopharmaceutical
Development and Manufacture with Science- and
Risk-Based Strategies
Saroj Ramdas, Renata Varga, Martin Gastens, Twinkle R. Christian,
Bharat Jagannathan, Barbara Rellahan, and Jillian Brady
42 Extrapolating Data from Adult Clinical Trials
to Advance Pediatric Drug Development
Sebastian Haertter, S.Y. Amy Cheung, Angela James, Ashley Strougo,
Christina Bucci-Rechtweg, Jing Liu, Meina Tao Tang, Paulien Ravenstijn,
Raafat Bishai, Satyendra Suryawanshi, and Solange Corriol-Rohou
48 Collaborative Efforts Address
Key Data Integrity Challenges
Ganapathy Mohan, Christopher Turner, Dennis O'Connor, Lisa Fink,
Thomas Purdue, Jeffrey Beebie, Kerri Robles, and Karen Waetjen
RESOURCES
52 Resources, Guidelines, and Guidance Documents
58 Regulatory and Standard Setting Organizations
61 Ad Index
Cover image: GoodIdeas - stock.adobe.com; Cover design, Maria Reyes
