Drug Approval

188 books
Bad Pharma: How Medicine is Broken, and How We Can Fix itBen Goldacre
⏱ 7h 17m

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

Ben Goldacre

2001437 pp.
Statistical Thinking for Non-Statisticians in Drug RegulationRichard Kay
⏱ 4h 56m

Statistical Thinking for Non-Statisticians in Drug Regulation

Richard Kay

2007296 pp.
FDA regulatory affairsDouglas J. Pisano
⏱ 6h 16m

FDA regulatory affairs

Douglas J. Pisano

2003376 pp.
Computer applications in pharmaceutical research and developmentSean Ekins
⏱ 13h 25m

Computer applications in pharmaceutical research and development

Sean Ekins

2006805 pp.
DrugsRick Ng
⏱ 8h 0m

Drugs

Rick Ng

2005480 pp.
New Drug DevelopmentChandrahas Sahajwalla
⏱ 8h 20m

New Drug Development

Chandrahas Sahajwalla

2004500 pp.
Generic drug product developmentLeon Shargel
⏱ 5h 10m

Generic drug product development

Leon Shargel

2007310 pp.
Biosimilar Drug Product DevelopmentLaszlo Endrenyi
⏱ 7h 57m

Biosimilar Drug Product Development

Laszlo Endrenyi

2017477 pp.
International Stability TestingDavid J. Mazzo
⏱ 5h 52m

International Stability Testing

David J. Mazzo

1998352 pp.
Development and approval of combination productsEvan B. Siegel
⏱ 3h 36m

Development and approval of combination products

Evan B. Siegel

2008216 pp.
Pediatric non-clinical drug testingAlan M. Hoberman
⏱ 5h 56m

Pediatric non-clinical drug testing

Alan M. Hoberman

2011356 pp.
Early drug developmentMitchell N. Cayen
⏱ 10h 54m

Early drug development

Mitchell N. Cayen

2010654 pp.
Clinical trialsTom Brody
⏱ 14h 56m

Clinical trials

Tom Brody

2011896 pp.
New drug approval processRichard A. Guarino
⏱ 9h 12m

New drug approval process

Richard A. Guarino

2004552 pp.
Analytical Similarity Assessment in Biosimilar Product DevelopmentShein-Chung Chow
⏱ 5h 40m

Analytical Similarity Assessment in Biosimilar Product Development

Shein-Chung Chow

2018340 pp.
Medical writing in drug developmentRobert J. Bonk
⏱ 2h 19m

Medical writing in drug development

Robert J. Bonk

1998139 pp.
The Textbook of Pharmaceutical MedicineJ. P. Griffin
⏱ 14h 15m

The Textbook of Pharmaceutical Medicine

J. P. Griffin

2013855 pp.
Inside the FDAFran Hawthorne
⏱ 5h 13m

Inside the FDA

Fran Hawthorne

2005313 pp.
The CRA's guide to monitoring clinical researchKaren E. Woodin
⏱ 7h 34m

The CRA's guide to monitoring clinical research

Karen E. Woodin

2008454 pp.
Pharmaceutical research and its value to canadiansDavid Griller
⏱ 1h 3m

Pharmaceutical research and its value to canadians

David Griller

200663 pp.
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