New drug approval process /
New drug approval process /
edited by Richard A. Guarino.
- fifth edition.
- xviii, 529 pages : illustrations ; 24 cm
- Drugs and the pharmaceutical sciences ; v. 190 .
- Drugs and the pharmaceutical sciences ; v. 190. .
pharmacy bookfair2016
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.
9781420088496 (hardcover : alk. paper) 1420088491 (hardcover : alk. paper)
2009007532
101496762 DNLM
Drug approval--United States.
Drugs--Testing--Standards.
Drugs--Testing--Government policy--United States.
New products--Government policy--United States.
Drug Evaluation--standards--United States.
Clinical Trials as Topic--standards--United States.
Drug Approval--United States.
RS189 / .N476 2009
615.1 / N
pharmacy bookfair2016
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.
9781420088496 (hardcover : alk. paper) 1420088491 (hardcover : alk. paper)
2009007532
101496762 DNLM
Drug approval--United States.
Drugs--Testing--Standards.
Drugs--Testing--Government policy--United States.
New products--Government policy--United States.
Drug Evaluation--standards--United States.
Clinical Trials as Topic--standards--United States.
Drug Approval--United States.
RS189 / .N476 2009
615.1 / N