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|a 1038057767
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|a 9780128125700
|q (electronic book)
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|a 0128125705
|q (electronic book)
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|z 9780128125120
|q (paperback)
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|z 0128125128
|q (paperback)
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|a (OCoLC)1037946027
|z (OCoLC)1038057767
|z (OCoLC)1041899747
|z (OCoLC)1126195298
|z (OCoLC)1229475614
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|a RC271.C5
|b N68 2018
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|a Novel designs of early phase trials for cancer therapeutics /
|c edited by Shivaani Kummar, Chris Takimoto.
|
| 264 |
|
1 |
|a London, United Kingdom ;
|a San Diego, CA :
|b Academic Press, an imprint of Elsevier,
|c [2018]
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| 300 |
|
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|a 1 online resource
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| 336 |
|
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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| 500 |
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|a Includes index.
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| 505 |
0 |
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|a Front Cover; Novel Designs of Early Phase Trials for Cancer Therapeutics; Copyright Page; Dedication; Contents; List of Contributors; Preface; 1 Changing Landscape of Early Phase Clinical Trials: Beyond the Horizon; 1.1 Historical Perspective; 1.2 Current Trends; References; 2 Requirements for Filing an Investigational New Drug Application; 2.1 Exemptions to Filing an IND; 2.2 Types of IND Applications; 2.3 Regulatory and Administrative Components of an IND Application; 2.4 FDA IND Review; 2.5 IND Reporting Requirements; 2.5.1 Expedited Safety Reporting; 2.5.2 Annual Reporting
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|a 2.6 FDA Meetings2.7 IND Applications for Combination Therapies; 2.8 Applications for Companion Diagnostic Devices; 3 The Evolution of Phase I Trials, Past, Present, and Future: A Biostatistical Perspective; 3.1 Traditional Dose Finding: Toxicity-Based Designs; 3.1.1 Common Trial Designs for Toxicity-Based Dose Finding of Single Agents; 3.1.2 Toxicity-Based Dose-Finding Designs for Combinations; 3.1.3 Other Toxicity-Based Dose-Finding Designs; 3.1.4 (Re)defining Toxicity Endpoints; 3.2 Efficacy and Toxicity-Based Dose-Finding Designs; 3.3 Expansion Cohorts and Phase I/II Trials
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|a 3.4 Recent Trends in Phase I Trial Designs3.4.1 Breakthrough Therapy Designation and Its Impact on Trial Designs; 3.4.2 Statistical Challenges in Dose Finding Based in the Era of Immunotherapies and Targeted Agents; 3.5 Where Do We Go From Here: Recommendations for Optimal Early Phase Dose-Finding Trials; 3.5.1 Windows of Time for Evaluation of Toxicities; 3.5.2 Intrapatient Dose Escalation; 3.5.3 Delayed Clinical Responses, "Pseudo-Progression," and Duration of Response; 3.5.4 Measures of Efficacy for Dose Finding: Clinical Versus Correlative Outcomes; 3.5.5 Sample Size and Cohort Selection
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| 505 |
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|a 3.5.6 Using Expansion Cohorts to Recalibrate Dose3.5.7 Abandon the Terms "Phase I, II, and III"; 3.6 Summary; References; 4 Evolving Early Phase Trial Designs: A Regulatory Perspective; 4.1 Introduction; 4.2 FDA Expedited Programs for Expediting the Development and Review of Drugs for Serious or Life-Threatening Conditions; 4.2.1 Fast Track Development Program Designation; 4.2.2 Breakthrough Therapy Development Program Designation; 4.2.3 Priority Review Designation of a New Drug Application/Biologics License Application; 4.2.4 Accelerated Approval and Regular Approval
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|a 4.3 Multiarm Expansion Cohorts in Early Phase Trials4.3.1 Traditional Drug Development Paradigm and Seamless Oncology Expansion Cohort Drug Development Paradigm; 4.3.2 Examples of Expansion Cohorts in Seamless Oncology Trials; 4.3.3 Regulatory Considerations of Seamless Oncology Expansion Cohort FIH Trials-Opportunities and Challenges; 4.3.3.1 Safety Considerations; 4.3.3.2 Efficacy Considerations; 4.4 Summary; References; 5 The Challenges of Implementing Multiarmed Early Phase Oncology Clinical Trials; 5.1 Introduction; 5.2 Evolution of Early Phase Clinical Trials; 5.2.1 Endpoints
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| 504 |
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|a Includes bibliographical references and index.
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| 588 |
0 |
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|a Online resource; title from digital title page (viewed on May 06, 2020).
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| 650 |
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0 |
|a Antineoplastic agents
|x Testing.
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| 650 |
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0 |
|a Drug development.
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| 650 |
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0 |
|a Chemotherapy.
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| 650 |
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2 |
|a Neoplasms
|0 (DNLM)D009369
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| 650 |
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2 |
|a Drug Therapy
|0 (DNLM)D004358
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| 650 |
1 |
2 |
|a Antineoplastic Agents
|x therapeutic use
|0 (DNLM)D000970Q000627
|
| 650 |
1 |
2 |
|a Antineoplastic Agents
|x pharmacology
|0 (DNLM)D000970Q000494
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| 650 |
|
6 |
|a M�edicaments
|x D�eveloppement.
|0 (CaQQLa)201-0306620
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| 650 |
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6 |
|a Chimioth�erapie.
|0 (CaQQLa)201-0034750
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| 650 |
|
7 |
|a MEDICAL
|x Pharmacology.
|2 bisacsh
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| 650 |
|
7 |
|a Chemotherapy
|2 fast
|0 (OCoLC)fst00853595
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| 650 |
|
7 |
|a Antineoplastic agents
|x Testing
|2 fast
|0 (OCoLC)fst00810608
|
| 650 |
|
7 |
|a Drug development
|2 fast
|0 (OCoLC)fst00898670
|
| 655 |
|
4 |
|a Internet Resources.
|
| 655 |
|
4 |
|a Charts.
|
| 700 |
1 |
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|a Kummar, Shivaani,
|e editor.
|
| 700 |
1 |
|
|a Takimoto, Chris,
|e editor.
|
| 776 |
0 |
8 |
|i Print version:
|t Novel designs of early phase trials for cancer therapeutics.
|d London, United Kingdom : Academic Press, an imprint of Elsevier, 2018
|z 0128125128
|z 9780128125120
|w (OCoLC)1011518186
|
| 856 |
4 |
0 |
|u https://sciencedirect.uam.elogim.com/science/book/9780128125120
|z Texto completo
|
