New drug approval process : accelerating global registrations
著者
書誌事項
New drug approval process : accelerating global registrations
（Drugs and the pharmaceutical sciences, v. 139）
M. Dekker, c2004
4th ed
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
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 regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.
目次
PARTIAL CONTENTS Regulatory Practices and Procedures of New Drug, Biologics and Device Development New Product Development Teams Duane B. Lakings Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology Duane B. Lakings The Investigational New Drug Application (IND) and the Investigator's Brochure (IB) William M. Troetel Clinical Research Development Clinical Research Protocols Richard A. Guarino Adverse Experiences, Adverse Reactions and Interactions of Drugs Richard A. Guarino Statistical and Data Management Collaboration in Clinical Research Mark Bradshaw and Lawrence A. Meinert Specific Aspects in the Process of New Product Submissions Chemistry, Manufacturing and Control (CMC) Requirements of the NDA and ANDA Evan Siegel Data Presentation for FDA Submissions: Text and Tabular Exposition Patricia Blaine Preparing for FDA Inspections: Manufacturing Sites Timothy Urschel Global Applications of Good Clinical Practices (GCPs) Obligations of the Investigator, Sponsor and Monitor Richard A. Guarino Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and Informed Consent (IC): Protecting Subjects throughout the Clinical Research Process Rochelle L. Goodson Quality Assurance Earl W. Hulihan
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