Explore Books on
drug approval

Statistical Thinking for Non-Statisticians in Drug Regulation

By Richard Kay

FDA regulatory affairs

By Douglas J. Pisano

Drugs

By Rick Ng

Generic drug product development

By Leon Shargel,Isadore Kanfer

Pediatric non-clinical drug testing

By Alan M. Hoberman,Elise M. Lewis

Pharmaceutical engineering change control

By Simon G. Turner

Inside the FDA

By Fran Hawthorne

Developing a National Registry of Pharmacologic and Biologic Clinical Trials

By Committee on Clinical Trial Registries

New Drug Development

By Chandrahas Sahajwalla

International Stability Testing

By David J. Mazzo

Analytical Similarity Assessment in Biosimilar Product Development

By Shein-Chung Chow

Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

By Mark Chang,John Balser,Jim Roach,Robin Bliss

Nonclinical Safety Assessment

By William J. Brock,Kenneth L. Hastings,Kathy M. McGown

Biosimilar Drug Product Development

By Laszlo Endrenyi,Paul Declerck,Shein-Chung Chow

Bad Pharma: How Medicine is Broken, and How We Can Fix it

By Ben Goldacre

Early drug development

By Mitchell N. Cayen

Pharmaceutical lifecycle management

By Tony Ellery

Medical writing in drug development

By Robert J. Bonk

The Textbook of Pharmaceutical Medicine

By J. P. Griffin,John Posner,Geoffrey R. Barker

Biosimilarity

By Sarfaraz K. Niazi

Nuclear Medicine in Pharmaceutical Research

By A. C. Perkins,M. Frier

Development and approval of combination products

By Evan B. Siegel

Computer applications in pharmaceutical research and development

By Sean Ekins

The Future of Drug Safety

By Committee on the Assessment of the US Drug Safety System