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New Drug Approval Process : Drugs and the Pharmaceutical Sciences - Richard Guarino

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New Drug Approval Process

Name: New Drug Approval Process
Brand: Taylor & Francis Inc
Price: 331.75 AUD
Availability: BackOrder

By: Richard Guarino (Editor), Richard A. Guarino (Editor)

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Hardcover | 24 June 2009 | Edition Number 5

At a Glance

Hardcover
548 Pages

Edition Type
New edition

Dimensions(cm)
23.7 x 16.0 x 3.5

Hardcover

RRP $399.00

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The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

Updated chapters include:

advances in international regulatory requirements, including ICH guidelines and harmonization
a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
the latest regulatory requirements for expediting new drug approvals
strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development

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You Can Find This Book In

Non-Fiction Medicine Other Branches of Medicine Pharmacology Nursing & Ancillary Services Pharmacy & Dispensing Engineering & Technology Industrial Chemistry & Manufacturing Technologies Industrial Chemistry Pharmaceutical Technology Medicine in General Medical Equipment & Techniques

Medical Research Clinical Trials Science Biology, Life Sciences

Preface	p. ix
Contributors	p. xv
Introduction	p. xvii
Administrative Guidelines for New Product Development
Drug Development Teams	p. 1
FDA Approvable Indications and Other Considerations	p. 14
Data Presentation for Global Submissions: Text and Tabular Exposition-CTD Format	p. 23
Technology Change-Enabling Clinical Research and Drug Development Processes	p. 29
Working with a Contract Research Organization (CRO)	p. 42
Industry and FDA Liaison	p. 56
Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approval
Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology	p. 75
The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB)	p. 110
New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats	p. 145
Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)	p. 166
The CTD and eCTD for the Registration of Pharmaceuticals for Human Use	p. 180
The Biologic License Application	p. 219
Chemistry, Manufacturing, and Control (ICH Quality Guidelines)	p. 241
New Medical Device Approval Process in the United States	p. 266
Orphan Drugs	p. 287
Developing Clinical Research Trials
Clinical Research Protocols	p. 301
Institutional Review Board/Independent Ethics Committe and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials	p. 325
HIPPA: A New Requirement to the Clinical Study Process	p. 341
Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting	p. 352
Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions	p. 376
Global Regulations for Good Clinical Practices (GCP)
CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors	p. 393
Quality Assurance	p. 402
Managing and Monitoring Clinical Trials	p. 411
European CT Directive: Implementation and Update	p. 427
Specific Areas of New Product Submissions
Combination Products	p. 439
The Current State of GXP in China	p. 461
Acronyms and Initialisms	p. 509
Index	p. 525
Table of Contents provided by Ingram. All Rights Reserved.

New Drug Approval Process

At a Glance

Hardcover

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How to return your order

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