Guidebook For Drug Regulatory Submissions

Author: Sandy Weinberg
Publisher: John Wiley & Sons
ISBN: 0470456175
Size: 63.22 MB
Format: PDF
View: 4332
Download Read Online
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: 47.69 MB
Format: PDF, Docs
View: 3817
Download Read Online
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: 0123919118
Size: 20.60 MB
Format: PDF, ePub
View: 451
Download Read Online
This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts.

Pharmaceutical Toxicology In Practice

Author: Alberto Lodola
Publisher: John Wiley & Sons
ISBN: 0470922729
Size: 75.67 MB
Format: PDF, Mobi
View: 620
Download Read Online
This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development.

Understanding Membrane Distillation And Osmotic Distillation

Author: Robert A. Johnson
Publisher: John Wiley & Sons
ISBN: 0470122161
Size: 13.36 MB
Format: PDF, Docs
View: 164
Download Read Online
This book addresses principles and practical applications of membrane distillation and osmotic distillation, separation technologies which are gaining increasing attention due to their advantages over conventional concentration processes. ...

Targets And Emerging Therapies For Schizophrenia

Author: Jeffrey S. Albert
Publisher: John Wiley & Sons
ISBN: 1118309405
Size: 22.61 MB
Format: PDF, Docs
View: 6435
Download Read Online
Integrating chemistry, biology, and pharmacology, this book explores emerging directions in pharmaceutical research for drug targeting and discovery in order to find more effective treatments for schizophrenia, one of the most serious and ...

Generic Drug Product Development

Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086367
Size: 37.34 MB
Format: PDF, Kindle
View: 7446
Download Read Online
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 ...

New Drug Development

Author: J. Rick Turner
Publisher: Springer Science & Business Media
ISBN: 9781441964182
Size: 35.21 MB
Format: PDF, ePub, Mobi
View: 3058
Download Read Online
This edition builds on the success of the first edition by keeping the discussions that were most helpful to readers, and adding new chapters addressing important contemporary topics in drug development.

New Drug Approval Process

Author: Richard A. Guarino
Publisher: Informa Health Care
ISBN: 0824750411
Size: 63.25 MB
Format: PDF, Kindle
View: 264
Download Read Online
Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific ...