New Drug Approval Process: 5th Edition (Hardback) book cover

New Drug Approval Process

5th Edition

Edited by Richard A. Guarino, Richard Guarino

CRC Press

552 pages | 80 B/W Illus.

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Hardback: 9781420088496
pub: 2009-06-24
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Description

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

Table of Contents

ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT

Drug Development Teams

Duane B. Lakings

FDA Approvable Indications and Other Considerations

Peter Levitch

Data Presentation for Global Submissions: Text and Tabular Exposition—CTD Format

Patricia Blaine

Technology Change—Enabling Clinical Research and Drug Development Processes

Brian J. Chadwick

Working with a Contract Research Organization (CRO)

Duane B. Lakings

6 Industry and FDA Liaison 56

Richard A. Guarino

GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL

Nonclinical Drug Development: Pharmacology, Drug Metabolism, and

Toxicology

Duane B. Lakings

The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator’s Brochure (IB)

Richard A. Guarino

New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats

Richard A. Guarino

Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs)

Richard A. Guarino

The CTD and eCTD for the Registration of Pharmaceuticals for Human Use

Duane B. Lakings

The Biologic License Application

Albert A. Ghignone

Chemistry, Manufacturing, and Control (ICH Quality Guidelines)

John R. Rapoza and Evan B. Siegel

New Medical Device Approval Process in the United States

Max Sherman

Orphan Drugs

Richard A. Guarino

DEVELOPING CLINICAL RESEARCH TRIALS

Clinical Research Protocols

Richard A. Guarino

Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials

Rochelle L. Goodson

HIPAA: A New Requirement to the Clinical Study Process

Glenn D. Watt, Earl W. Hulihan, and Richard A. Guarino

Adverse Events and Reactions: Etiology, Drug Interactions, Collection, and Reporting

Richard A. Guarino

Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions

Mark Bradshaw

GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP)

CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors

Richard A. Guarino

Quality Assurance

Helena M. Van den Dungen, Earl W. Hulihan, and Richard A. Guarino

Managing and Monitoring Clinical Trials

Andrea Proccacino

European CT Directive: Implementation and Update

Kent Hill and Richard A. Guarino

SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS

Combination Products

Evan B. Siegel

The Current State of GXP in China

Earl W. Hulihan, Daniel Liu, Cai Cao, and Qingshan Zheng Acronyms and Initialisms

About the Series

Drugs and the Pharmaceutical Sciences

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology