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1. 
Cover image for FDA's drug review process and the package label : strategies for writing successful FDA submissions
FDA's drug review process and the package label : strategies for writing successful FDA submissions
Author 
Brody, Tom, author.
Preferred Shelf Number 
ONLINE
Electronic Access 
ScienceDirect https://www.sciencedirect.com/science/book/9780128146477
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2. 
Cover image for Pharmaceutical analysis for small molecules
Pharmaceutical analysis for small molecules
Author 
Davani, Behnam, editor.
Preferred Shelf Number 
RS420
Electronic Access 
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119425021
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3. 
Cover image for Preparing for FDA Pre-Approval Inspections : A Guide to Regulatory Success, Second Edition
Preparing for FDA Pre-Approval Inspections : A Guide to Regulatory Success, Second Edition
Author 
Hynes, Martin D., editor. Taylor and Francis.
Preferred Shelf Number 
RM301.27
Electronic Access 
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4. 
Cover image for Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
Author 
Brody, Tom, author.
Preferred Shelf Number 
ONLINE
Electronic Access 
ScienceDirect http://www.sciencedirect.com/science/book/9780128042175
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5. 
Cover image for Generic drug product development : solid oral dosage forms
Generic drug product development : solid oral dosage forms
Author 
Shargel, Leon, 1941- Kanfer, Isadore.
Preferred Shelf Number 
RS55.2 .G46 2014
Electronic Access 
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6. 
Cover image for Design and analysis of bridging studies
Design and analysis of bridging studies
Author 
Hsiao, Chin-Fu, 1964- Liu, Jen-pei, 1952- Chow, Shein-Chung, 1955-
Preferred Shelf Number 
RM301.27 .D47 2013
Electronic Access 
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7. 
Cover image for Clinical trials study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
Clinical trials study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
Author 
Brody, Tom.
Preferred Shelf Number 
ONLINE
Electronic Access 
ScienceDirect An electronic book accessible through the World Wide Web; click for information
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8. 
Cover image for Safety pharmacology in pharmaceutical development : approval and post marketing surveillance
Safety pharmacology in pharmaceutical development : approval and post marketing surveillance
Author 
Gad, Shayne C., 1948, author. Gad, Shayne C., 1948- Safety pharmacology in pharmaceutical development and approval.
Preferred Shelf Number 
RM301.25 .G33 2012
Electronic Access 
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9. 
Cover image for Pediatric nonclinical drug testing principles, requirements, and practices
Pediatric nonclinical drug testing principles, requirements, and practices
Author 
Hoberman, Alan M. Lewis, Elise M.
Preferred Shelf Number 
ONLINE
Electronic Access 
Connect to MyiLibrary resource
Wiley InterScience An electronic book accessible through the World Wide Web; click for information
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10. 
Cover image for Pharmaceutical lifecycle management making the most of each and every brand
Pharmaceutical lifecycle management making the most of each and every brand
Author 
Ellery, Tony. Hansen, Neal. Wiley InterScience (Online service)
Preferred Shelf Number 
ONLINE
Electronic Access 
Wiley InterScience An electronic book accessible through the World Wide Web; click for information
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11. 
Cover image for Clinical trial methodology
Clinical trial methodology
Author 
Peace, Karl E., 1941, author. Chen, Ding-Geng.
Preferred Shelf Number 
R853 .C55 P43 2011
Electronic Access 
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12. 
Cover image for A clinical trials manual from the Duke Clinical Research Institute lessons from a horse named Jim
A clinical trials manual from the Duke Clinical Research Institute lessons from a horse named Jim
Author 
Liu, Margaret B. Davis, Kate (Kate G.) Liu, Margaret B. Lessons from a horse named Jim. Duke Clinical Research Institute. Wiley InterScience (Online service)
Preferred Shelf Number 
ONLINE
Electronic Access 
Contributor biographical information http://catdir.loc.gov/catdir/enhancements/fy0917/2009020427-b.html
John Wiley http://dx.doi.org/10.1002/9781444315219
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