Holdings: Clinical trials of drugs and biopharmaceuticals

Clinical trials of drugs and biopharmaceuticals:

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Bibliographic Details
Format:	Book
Language:	English
Published:	Boca Raton, FL CRC Press/Taylor & Francis 2006
Subjects:	Médicaments - Essais cliniques Études cliniques Drugs > Testing Clinical trials Drug Evaluation > methods Clinical Trials, Phase I > methods Clinical Trials, Phase II > methods Clinical Trials, Phase III > methods Clinical Trials, Phase IV > methods
Online Access:	Publisher description Inhaltsverzeichnis
Item Description:	Rev. ed. of: Handbook of phase I/II clinical drug trials. 1997. Includes bibliographical references and index
Physical Description:	500 p. Ill., graph. Darst. 27 cm
ISBN:	0849321859

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MARC


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246	1	3	\|a Handbook of phase I/II clinical drug trials
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500			\|a Rev. ed. of: Handbook of phase I/II clinical drug trials. 1997.
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650		4	\|a Drugs \|x Testing
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650		4	\|a Clinical Trials, Phase II \|x methods
650		4	\|a Clinical Trials, Phase III \|x methods
650		4	\|a Clinical Trials, Phase IV \|x methods
700	1		\|a Lee, Chi-Jen \|e Sonstige \|4 oth
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adam_text	Contents PART I Preparation for Clinical Trials 1 Chapter 1 Drag Discovery and Preclinical Research 3 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Chapter 2 The Pharmaceutical Background 9 Shri C. Valvani Chapter 3 The Pharmacological Background for Drug Evaluation 23 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 4 Animal Tests as Predictors of Human Response 31 Peter I. Folb PART II Regulatory Organization and Decision Making 57 Chapter 5 Worldwide Regulatory Agencies 59 Christopher L. Wu, Benjamin R. Lee, and Mei Ling Chen Chapter 6 Decision Points in Drug Development 77 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 7 Management of Clinical Development Costs 87 Mark Hovde Chapter 8 Ethical Aspects and Good Clinical Practice 103 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 9 Investigational New Drug Application and the Licensure Approval Process 107 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 10 Clinical Trials from Phase I to Phase IV 113 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee PART III Evaluation and Quality Assurance of Drugs and Biopharmaceuticals 121 Chapter 11 The Assessment of Pharmacokinetics in Early Phase Drug Evaluation 123 Paul E. Rolan and Valeria Molnar Chapter 12 Drag Interactions 133 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee PART IV Assessment of Cardiovascular Drugs 143 Chapter 13 Antianginal Drugs 145 Nancy C. Pauly and Edmond Roland Chapter 14 Antihypertensive Drugs 165 W. Stephen Waring and David J. Webb Chapter 15 Drugs for Treatment of Stroke 201 Mariola Soehngen, Wolfgang Soehngen, and Yasir Al Rawi PART V Assessment of Respiratory Drugs 237 Chapter 16 Antiasthmatic Drugs 239 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee PART VI Assessment of Central Nervous System Drugs 249 Chapter 17 Anxiolytics and Hypnotics 251 Graham R. McClelland and Georges Moroz Chapter 18 Antidepressants 269 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 19 Drugs for Alzheimer s Disease and Other Dementias 279 Benjamin R. Lee, Lucia H. Lee, Christopher L. Wu, and Chi Jen Lee PART VII Assessment of Gastrointestinal and Liver Drugs 289 Chapter 20 Antiulcer Drugs 291 Benjamin R. Lee, Lucia H. Lee, Christopher L. Wu, and Chi Jen Lee PART VIII Assessment of Genitourinary Drugs 303 Chapter 21 Diuretics 305 Hitesh H. Shah, Pravin C. Singhal, and Joseph Mattana Chapter 22 Medical Therapy of Benign Prostatic Hyperplasia 317 Benjamin R. Lee PART IX Assessment of Skin Drugs 323 Chapter 23 Drugs for the Treatment of Specific Skin Diseases 325 Muzlifah A. Haniffa, Anton B. Alexandroff Vrach, Suzy N. Leech, and Clifford M. Lawrence Chapter 24 Drugs for the Treatment of Atopic Eczema 345 Christopher L. Wu, Lucia H. Lee, Benjamin R. Lee, and Chi Jen Lee PART X Assessment of Metabolism Drugs 353 Chapter 25 Drugs for Treatment of Disorders of Lipid Metabolism 355 Christopher L. Wu, Lucia H. Lee, Benjamin R. Lee, and Chi Jen Lee Chapter 26 Antidiabetic Drugs 363 Christopher L. Wu, Lucia H. Lee, Benjamin R. Lee, and Chi Jen Lee PART XI Assessment of Chemotherapeutic Drugs 373 Chapter 27 Antibiotics 375 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 28 Antiviral Drugs 391 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 29 Anticancer Drugs 401 Robert E. Martell, Christiane Longer, and Renzo Canetta PART XII Assessment of Antiinflammatory and Pain Drugs 421 Chapter 30 Analgesics 423 Christopher L. Wu, Robert W. Hurley, and Joseph W. Stauffer PART XIII Assessment of Biopharmaceuticals 443 Chapter 31 Vaccines 445 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Chapter 32 Herbal Products as Complementary and Alternative Medicine 459 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Chapter 33 Biotechnology Derived Pharmaceuticals 469 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee PART XIV Future Perspective 477 Chapter 34 Future Perspectives in Drug Development 479 Christopher L. Wu, Benjamin R. Lee, and Mei Ling Chen Chapter 35 Future Perspectives in Biopharmaceutical Development 485 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Index 495
adam_txt	Contents PART I Preparation for Clinical Trials 1 Chapter 1 Drag Discovery and Preclinical Research 3 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Chapter 2 The Pharmaceutical Background 9 Shri C. Valvani Chapter 3 The Pharmacological Background for Drug Evaluation 23 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 4 Animal Tests as Predictors of Human Response 31 Peter I. Folb PART II Regulatory Organization and Decision Making 57 Chapter 5 Worldwide Regulatory Agencies 59 Christopher L. Wu, Benjamin R. Lee, and Mei Ling Chen Chapter 6 Decision Points in Drug Development 77 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 7 Management of Clinical Development Costs 87 Mark Hovde Chapter 8 Ethical Aspects and Good Clinical Practice 103 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 9 Investigational New Drug Application and the Licensure Approval Process 107 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 10 Clinical Trials from Phase I to Phase IV 113 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee PART III Evaluation and Quality Assurance of Drugs and Biopharmaceuticals 121 Chapter 11 The Assessment of Pharmacokinetics in Early Phase Drug Evaluation 123 Paul E. Rolan and Valeria Molnar Chapter 12 Drag Interactions 133 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee PART IV Assessment of Cardiovascular Drugs 143 Chapter 13 Antianginal Drugs 145 Nancy C. Pauly and Edmond Roland Chapter 14 Antihypertensive Drugs 165 W. Stephen Waring and David J. Webb Chapter 15 Drugs for Treatment of Stroke 201 Mariola Soehngen, Wolfgang Soehngen, and Yasir Al Rawi PART V Assessment of Respiratory Drugs 237 Chapter 16 Antiasthmatic Drugs 239 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee PART VI Assessment of Central Nervous System Drugs 249 Chapter 17 Anxiolytics and Hypnotics 251 Graham R. McClelland and Georges Moroz Chapter 18 Antidepressants 269 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 19 Drugs for Alzheimer's Disease and Other Dementias 279 Benjamin R. Lee, Lucia H. Lee, Christopher L. Wu, and Chi Jen Lee PART VII Assessment of Gastrointestinal and Liver Drugs 289 Chapter 20 Antiulcer Drugs 291 Benjamin R. Lee, Lucia H. Lee, Christopher L. Wu, and Chi Jen Lee PART VIII Assessment of Genitourinary Drugs 303 Chapter 21 Diuretics 305 Hitesh H. Shah, Pravin C. Singhal, and Joseph Mattana Chapter 22 Medical Therapy of Benign Prostatic Hyperplasia 317 Benjamin R. Lee PART IX Assessment of Skin Drugs 323 Chapter 23 Drugs for the Treatment of Specific Skin Diseases 325 Muzlifah A. Haniffa, Anton B. Alexandroff Vrach, Suzy N. Leech, and Clifford M. Lawrence Chapter 24 Drugs for the Treatment of Atopic Eczema 345 Christopher L. Wu, Lucia H. Lee, Benjamin R. Lee, and Chi Jen Lee PART X Assessment of Metabolism Drugs 353 Chapter 25 Drugs for Treatment of Disorders of Lipid Metabolism 355 Christopher L. Wu, Lucia H. Lee, Benjamin R. Lee, and Chi Jen Lee Chapter 26 Antidiabetic Drugs 363 Christopher L. Wu, Lucia H. Lee, Benjamin R. Lee, and Chi Jen Lee PART XI Assessment of Chemotherapeutic Drugs 373 Chapter 27 Antibiotics 375 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 28 Antiviral Drugs 391 Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, and Chi Jen Lee Chapter 29 Anticancer Drugs 401 Robert E. Martell, Christiane Longer, and Renzo Canetta PART XII Assessment of Antiinflammatory and Pain Drugs 421 Chapter 30 Analgesics 423 Christopher L. Wu, Robert W. Hurley, and Joseph W. Stauffer PART XIII Assessment of Biopharmaceuticals 443 Chapter 31 Vaccines 445 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Chapter 32 Herbal Products as Complementary and Alternative Medicine 459 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Chapter 33 Biotechnology Derived Pharmaceuticals 469 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee PART XIV Future Perspective 477 Chapter 34 Future Perspectives in Drug Development 479 Christopher L. Wu, Benjamin R. Lee, and Mei Ling Chen Chapter 35 Future Perspectives in Biopharmaceutical Development 485 Chi Jen Lee, Lucia H. Lee, Christopher L. Wu, and Benjamin R. Lee Index 495
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spelling	Clinical trials of drugs and biopharmaceuticals [edited by] Chi-Jen Lee ... [et al.] Handbook of phase I/II clinical drug trials Boca Raton, FL CRC Press/Taylor & Francis 2006 500 p. Ill., graph. Darst. 27 cm txt rdacontent n rdamedia nc rdacarrier Rev. ed. of: Handbook of phase I/II clinical drug trials. 1997. Includes bibliographical references and index Médicaments - Essais cliniques Études cliniques Drugs Testing Clinical trials Drug Evaluation methods Clinical Trials, Phase I methods Clinical Trials, Phase II methods Clinical Trials, Phase III methods Clinical Trials, Phase IV methods Lee, Chi-Jen Sonstige oth http://www.loc.gov/catdir/enhancements/fy0646/2005043902-d.html Publisher description HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014923698&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis
spellingShingle	Clinical trials of drugs and biopharmaceuticals Médicaments - Essais cliniques Études cliniques Drugs Testing Clinical trials Drug Evaluation methods Clinical Trials, Phase I methods Clinical Trials, Phase II methods Clinical Trials, Phase III methods Clinical Trials, Phase IV methods
title	Clinical trials of drugs and biopharmaceuticals
title_alt	Handbook of phase I/II clinical drug trials
title_auth	Clinical trials of drugs and biopharmaceuticals
title_exact_search	Clinical trials of drugs and biopharmaceuticals
title_exact_search_txtP	Clinical trials of drugs and biopharmaceuticals
title_full	Clinical trials of drugs and biopharmaceuticals [edited by] Chi-Jen Lee ... [et al.]
title_fullStr	Clinical trials of drugs and biopharmaceuticals [edited by] Chi-Jen Lee ... [et al.]
title_full_unstemmed	Clinical trials of drugs and biopharmaceuticals [edited by] Chi-Jen Lee ... [et al.]
title_short	Clinical trials of drugs and biopharmaceuticals
title_sort	clinical trials of drugs and biopharmaceuticals
topic	Médicaments - Essais cliniques Études cliniques Drugs Testing Clinical trials Drug Evaluation methods Clinical Trials, Phase I methods Clinical Trials, Phase II methods Clinical Trials, Phase III methods Clinical Trials, Phase IV methods
topic_facet	Médicaments - Essais cliniques Études cliniques Drugs Testing Clinical trials Drug Evaluation methods Clinical Trials, Phase I methods Clinical Trials, Phase II methods Clinical Trials, Phase III methods Clinical Trials, Phase IV methods
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