Clinical trials of drugs and biopharmaceuticals:
Gespeichert in:
Format: | Buch |
---|---|
Sprache: | English |
Veröffentlicht: |
Boca Raton, FL
CRC Press/Taylor & Francis
2006
|
Schlagworte: | |
Online-Zugang: | Publisher description Inhaltsverzeichnis |
Beschreibung: | Rev. ed. of: Handbook of phase I/II clinical drug trials. 1997. Includes bibliographical references and index |
Beschreibung: | 500 p. Ill., graph. Darst. 27 cm |
ISBN: | 0849321859 |
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245 | 1 | 0 | |a Clinical trials of drugs and biopharmaceuticals |c [edited by] Chi-Jen Lee ... [et al.] |
246 | 1 | 3 | |a Handbook of phase I/II clinical drug trials |
264 | 1 | |a Boca Raton, FL |b CRC Press/Taylor & Francis |c 2006 | |
300 | |a 500 p. |b Ill., graph. Darst. |c 27 cm | ||
336 | |b txt |2 rdacontent | ||
337 | |b n |2 rdamedia | ||
338 | |b nc |2 rdacarrier | ||
500 | |a Rev. ed. of: Handbook of phase I/II clinical drug trials. 1997. | ||
500 | |a Includes bibliographical references and index | ||
650 | 4 | |a Médicaments - Essais cliniques | |
650 | 4 | |a Études cliniques | |
650 | 4 | |a Drugs |x Testing | |
650 | 4 | |a Clinical trials | |
650 | 4 | |a Drug Evaluation |x methods | |
650 | 4 | |a Clinical Trials, Phase I |x methods | |
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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Datensatz im Suchindex
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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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isbn | 0849321859 |
language | English |
lccn | 2005043902 |
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physical | 500 p. Ill., graph. Darst. 27 cm |
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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 |
url | http://www.loc.gov/catdir/enhancements/fy0646/2005043902-d.html 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 |
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