Opis: New Drug Approval Process - Guarino

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. TOC: ..."a useful road map to understanding the requirements that a drug product must fulfill to achieve approval." Journal of Medicinal Chemistry "There are very useful formats, brochures, statistics, addresses and checklists provided...in order to have a clean picture of the entire drug approval process. "The book has accomplished the laborious task of obtaining about 600 indispensable acronyms.a must for researchers, libraries, project consultants and...regulatory personnel." Pharmaceutical Development and TechnologyPARTIAL 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

Szczegóły: New Drug Approval Process - Guarino

Tytuł: New Drug Approval Process
Autor: Guarino
Producent: Marcel Dekker
ISBN: 9780824750411
Rok produkcji: 2004
Ilość stron: 664
Oprawa: Twarda
Waga: 1 kg

Recenzje: New Drug Approval Process - Guarino