Textbook Details

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NOTE: Textbook information is subject to change at any time at the discretion of the faculty member. If you have questions or concerns, contact the Center for Professional Studies (765-496-0510 or prostar@purdue.edu). 

TLI 52100 - Drug Development (Julie Engel and Kari Clase)

Textbook Name Author Edition ISBN
New Drug Development:  A Regulatory Overview   Mark Mathieu  8th Ed 978-1882615858
Translating Molecules into Medicines Shobha N. Bhattachar, John Morrison, Daniel R. Mudra,  David M. Bender  1st Ed 978-3319500409

TLI 52200 - Good Regulatory Practices (Stacie Berkshire and Kari Clase)

Textbook Name Author Edition ISBN
New Drug Development:  A Regulatory Overview   Mark Mathieu  8th Ed 978-1882615858
12 Golden GCP Rules for Investigators Professor David Hutchinson   978-1903712702
12 Golden (ISO14155:2011) Rules for Medical Device Trials Prof David Hutchinson and Dr Joris Bannenberg   978-1908278050

TLI 52300 - Quality Management, Audits & Inspections (Padmaja Shivanand)

Textbook Name Author Edition ISBN
The Certified Improvement Associate Handbook   Russell T. Westcott and Grace L. Duffy 3rd Ed 978-0873898904

TLI 52500 - Molecular Basis in Manufacturing Pharmaceuticals (Dr. Stephen Byrn, Kari Clase, and Padmaja Shivanand)

Textbook Name Author Edition ISBN
The Theory and Practice of Industrial Pharmacy

Lachman, Lieberman and Kanig

3rd Ed

978-0812109771

Introduction to Pharmaceutical Unit Operations

David A Engers, Purdue Univ, and Peter LD Wildfong, Duquesne Univ