5th Edition

New Drug Approval Process




ISBN 9781420088496
Published June 24, 2009 by CRC Press
552 Pages 80 B/W Illustrations

USD $220.00

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Book 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

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