Guidebook For Drug Regulatory Submissions

Author: Sandy Weinberg
Publisher: John Wiley & Sons
ISBN: 0470456175
Size: 51.18 MB
Format: PDF, ePub
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Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration ...

Guidebook For Drug Regulatory Submissions

Author: Sandy Weinberg
Publisher: Wiley
ISBN: 9780470371381
Size: 70.41 MB
Format: PDF, ePub
View: 3897
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Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration ...

Cost Contained Regulatory Compliance

Author: Sandy Weinberg
Publisher: John Wiley & Sons
ISBN: 9781118002278
Size: 22.42 MB
Format: PDF, ePub, Mobi
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This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance.

Clinical Trials

Author: Tom Brody
Publisher: Academic Press
ISBN: 0123919134
Size: 11.18 MB
Format: PDF, ePub
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This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts.

Generic Drug Product Development

Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086359
Size: 22.62 MB
Format: PDF, ePub
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Major topics discussed include: Active pharmaceutical ingredients Experimental formulation development, including a new section on Quality by Design (QbD) Scale-up Commercial product formulation Quality control and bioequivalence Drug ...

Drugs For Life

Author: Joseph Dumit
Publisher: Duke University Press
ISBN: 0822348713
Size: 53.71 MB
Format: PDF, Docs
View: 1938
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Joseph Dumit argues that underlying Americans' burgeoning consumption of prescription drugs and the skyrocketing cost of healthcare is a relatively new perception of ourselves as inherently ill and in need of chronic treatment.

Pharmaceutical Computer Validation Introduction Guidebook

Author: Daniel Farb
Publisher: UniversityOfHealthCare
ISBN: 1594912629
Size: 18.78 MB
Format: PDF, Docs
View: 3572
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the matter to another Federal, State, or local government law enforcement or
regulatory agency for such action as that ... be submitted to the Food and Drug
Administration if the Commissioner determines, upon an evaluation of the
submission ...