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Title	New drug approval process : the global challenge / edited by Richard A. Guarino.
Imprint	New York : Marcel Dekker, 2000.
Edition	3rd ed.

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LOCATION	CALL #	STATUS	MESSAGE
OHIOLINK NETLIBRARY EBOOKS		ONLINE
View online

Series	Drugs and the pharmaceutical sciences ; v. 100
	Drugs and the pharmaceutical sciences ; v. 100.
Subject	Drugs -- Testing -- Standards.
	Drugs -- Testing -- Government policy -- United States.
	New products -- Government policy -- United States.
	Drug Evaluation -- standards -- United States.
	Clinical Trials -- standards -- United States.
Alt Name	Guarino, Richard A., 1935-

Table of Contents
	Preface
	Introduction
	Contributors
	Acronyms and Initialisms
Pt. I	Regulatory Aspects of New Drug Development
	1	Drug Development Teams / Duane B. Lakings	1
	2	Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology / Duane B. Lakings	17
	3	The Investigational New Drug Application and the Investigator's Brochure / William M. Troetel	55
	4	General Considerations of the NDA / Martha R. Charney	93
	5	Specific Requirements, Content, and Format of an NDA / Richard A. Guarino, Patricia Blaine	103
	6	The Biologic License Application (BLA) / Albert A. Ghignone, Douglas Testa	157
	7	Chemistry, Manufacturing and Control Requirements of the NDA, and ANDA / Ivy Bautista	189
Pt. II	Clinical Research Development
	8	Clinical Research Protocols / Richard A. Guarino	219
	9	Adverse Reactions and Interactions of Drugs / Richard A. Guarino	247
	10	Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Subjects Throughout the Clinical Research Process / Rochelle L. Goodson	271
	11	Statistical and Data Management: Collaboration in Clinical Research / Laurent M. Kassalow	289
	12	The Management of Clinical Studies / Ileana Maria Alexander	311
Pt. III	Good Clinical Practices
	13	Obligations of the Investigator, Sponsor, and Monitor / Richard A. Guarino	325
	14	Preparing for FDA Inspections: Manufacturing Sites / Timothy Urschel	335
	15	Quality Assurance / Earl W. Hulihan	349
Pt. IV	The Orphan Drug and the Rx to OTC Swith
	16	Orphan Drugs / John T. Zenno	361
	17	Clinical Development, Regulations, and Trends for OTC Drugs / William E. Gilbertson, Steven A. Francesco	375
Pt. V	Effective Methodology in Expediting NDA Approval
	18	Industry and FDA Liaison / William M. Troetel	393
	19	Data Presentation for FDA Submissions: Text and Tabular Exposition / Patricia Blaine	415
	20	The Computer World in New Drug Development / Chris Clauss	423
	21	Working with a CRO / Duane B. Lakings, Alexandra D. J. Mancini	439
	22	The Evolving SMO in the United States / Kenneth A. Getz	455
	Index		465

LOCATION	CALL #	STATUS	MESSAGE
OHIOLINK NETLIBRARY EBOOKS		ONLINE
View online

Series	Drugs and the pharmaceutical sciences ; v. 100
	Drugs and the pharmaceutical sciences ; v. 100.
Subject	Drugs -- Testing -- Standards.
	Drugs -- Testing -- Government policy -- United States.
	New products -- Government policy -- United States.
	Drug Evaluation -- standards -- United States.
	Clinical Trials -- standards -- United States.
Alt Name	Guarino, Richard A., 1935-
Description	1 online resource (xxxiii, 471 pages) : illustrations.
Edition	3rd ed.
Bibliography Note	Includes bibliographical references and index.
Contents	Regulatory aspects of new drug development -- Clinical research development -- Good clinical practices -- The orphan drug and the Rx to OTC switch -- Effective methodology is expediting NDA approval.
Note	Print version record.
ISBN	0585231362 (electronic bk.)
	9780585231365 (electronic bk.)
	0824703081 (alk. paper)
OCLC #	44961525
Additional Format	Print version: New drug approval process. 3rd ed. New York : Marcel Dekker, 2000 0824703081 (DLC) 99048629 (OCoLC)42429707

Table of Contents
	Preface
	Introduction
	Contributors
	Acronyms and Initialisms
Pt. I	Regulatory Aspects of New Drug Development
	1	Drug Development Teams / Duane B. Lakings	1
	2	Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology / Duane B. Lakings	17
	3	The Investigational New Drug Application and the Investigator's Brochure / William M. Troetel	55
	4	General Considerations of the NDA / Martha R. Charney	93
	5	Specific Requirements, Content, and Format of an NDA / Richard A. Guarino, Patricia Blaine	103
	6	The Biologic License Application (BLA) / Albert A. Ghignone, Douglas Testa	157
	7	Chemistry, Manufacturing and Control Requirements of the NDA, and ANDA / Ivy Bautista	189
Pt. II	Clinical Research Development
	8	Clinical Research Protocols / Richard A. Guarino	219
	9	Adverse Reactions and Interactions of Drugs / Richard A. Guarino	247
	10	Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Subjects Throughout the Clinical Research Process / Rochelle L. Goodson	271
	11	Statistical and Data Management: Collaboration in Clinical Research / Laurent M. Kassalow	289
	12	The Management of Clinical Studies / Ileana Maria Alexander	311
Pt. III	Good Clinical Practices
	13	Obligations of the Investigator, Sponsor, and Monitor / Richard A. Guarino	325
	14	Preparing for FDA Inspections: Manufacturing Sites / Timothy Urschel	335
	15	Quality Assurance / Earl W. Hulihan	349
Pt. IV	The Orphan Drug and the Rx to OTC Swith
	16	Orphan Drugs / John T. Zenno	361
	17	Clinical Development, Regulations, and Trends for OTC Drugs / William E. Gilbertson, Steven A. Francesco	375
Pt. V	Effective Methodology in Expediting NDA Approval
	18	Industry and FDA Liaison / William M. Troetel	393
	19	Data Presentation for FDA Submissions: Text and Tabular Exposition / Patricia Blaine	415
	20	The Computer World in New Drug Development / Chris Clauss	423
	21	Working with a CRO / Duane B. Lakings, Alexandra D. J. Mancini	439
	22	The Evolving SMO in the United States / Kenneth A. Getz	455
	Index		465

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