New drug approval process / edited by Richard A. Guarino.

Contributor(s):

Guarino, Richard A, 1935- [editor.]

Material type: Text

TextSeries: Drugs and the pharmaceutical sciences ; v. 190.Publisher: New York : Informa Healthcare, [2010]Edition: fifth editionDescription: xviii, 529 pages : illustrations ; 24 cmContent type:

text

Media type:

unmediated

Carrier type:

volume

ISBN:

9781420088496 (hardcover : alk. paper)
1420088491 (hardcover : alk. paper)

Subject(s):

DDC classification:

615.1 22 N

LOC classification:

RS189 .N476 2009

Online resources:

Abstract

Contents:

Front Cover -- Preface -- Contents -- PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT -- 1. Drug Development Teams -- 2. FDA Approvable Indications and Other Considerations -- 3. Data Presentation for Global Submissions: Text and Tabular Exposition-CTD Format -- 4. Technology Change-Enabling Clinical Research and Drug Development Processes -- 5. Working with a Contract Research Organization (CRO) -- 6 Industry and FDA Liaison -- PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL -- 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology -- 8. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB) -- 9. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats -- 10. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs) -- 11. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use -- 12. The Biologic License Application -- 13. Chemistry, Manufacturing, and Control (ICH Quality Guidelines) -- 14. New Medical Device Approval Process in the United States -- 15. Orphan Drugs -- PART III DEVELOPING CLINICAL RESEARCH TRIALS -- 16. Clinical Research Protocols -- 17. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials -- 18. HIPAA: A New Requirement to the Clinical Study Pr -- 19. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, andReporting -- 20. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions -- PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP) -- 21. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, andMonitors -- 22. Quality Assurance. 23. Managing and Monitoring Clinical Trials -- 24. European CT Directive: Implementation and Update -- PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS -- 25. Combination Products -- 26. The Current State of GXP in China -- Acronyms and Initialisms -- Index.

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Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Books	Main library A10	Pharmacy ( Clinical Pharmacy )	615.1 N (Browse shelf(Opens below))	Available		00012711

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Includes bibliographical references and index.

Front Cover --
Preface --
Contents --
PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT --
1. Drug Development Teams --
2. FDA Approvable Indications and Other Considerations --
3. Data Presentation for Global Submissions: Text and Tabular Exposition-CTD Format --
4. Technology Change-Enabling Clinical Research and Drug Development Processes --
5. Working with a Contract Research Organization (CRO) --
6 Industry and FDA Liaison --
PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL --
7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology --
8. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB) --
9. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats --
10. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs) --
11. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use --
12. The Biologic License Application --
13. Chemistry, Manufacturing, and Control (ICH Quality Guidelines) --
14. New Medical Device Approval Process in the United States --
15. Orphan Drugs --
PART III DEVELOPING CLINICAL RESEARCH TRIALS --
16. Clinical Research Protocols --
17. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials --
18. HIPAA: A New Requirement to the Clinical Study Pr --
19. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, andReporting --
20. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions --
PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP) --
21. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, andMonitors --
22. Quality Assurance. 23. Managing and Monitoring Clinical Trials --
24. European CT Directive: Implementation and Update --
PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS --
25. Combination Products --
26. The Current State of GXP in China --
Acronyms and Initialisms --
Index.

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