Shein-Chung Chow – författare
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89 produkter
Statistics in Drug Research
Methodologies and Recent Developments
E-bok, 2002
1266 kr
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Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the …
Innovative Statistics in Regulatory Science
Inbunden, 2019
2205 kr
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Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in …
Quantitative Methods for Traditional Chinese Medicine Development
Häftad, 2019
1076 kr
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A Western-Based Approach to Analyzing TCMsIn recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to …
Biosimilars
Design and Analysis of Follow-on Biologics
Häftad, 2019
1076 kr
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As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific …
Translational Medicine
Strategies and Statistical Methods
Av Dennis Cosmatos, Shein-Chung Chow
Häftad, 2019
1076 kr
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Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational …
Statistics in Drug Research
Methodologies and Recent Developments
Häftad, 2019
1045 kr
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Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the …
Statistical Design and Analysis in Pharmaceutical Science
Validation, Process Controls, and Stability
Av Shein-Chung Chow, Jen-pei Liu
Häftad, 2019
1047 kr
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"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Innovative Methods for Rare Disease Drug Development
Inbunden, 2020
2145 kr
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In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because …
Innovative Methods for Rare Disease Drug Development
Häftad, 2022
798 kr
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In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because …
Biosimilar Drug Product Development
Av Laszlo Endrenyi, Shein-Chung Chow m. fl.
Häftad, 2020
1135 kr
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When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug …
Advanced Statistics in Regulatory Critical Clinical Initiatives
Av Wei Zhang, Fangrong Yan m. fl.
Inbunden, 2022
2820 kr
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Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on …
Quantitative Methods for HIV/AIDS Research
Av Cliburn Chan, Michael G. Hudgens m. fl.
Häftad, 2020
785 kr
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Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research; …
Design and Analysis of Bridging Studies
Av Jen-pei Liu, Shein-Chung Chow m. fl.
Häftad, 2020
815 kr
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As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that …
Controversial Statistical Issues in Clinical Trials
Häftad, 2020
822 kr
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In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. …
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
Av Annpey Pong, Shein-Chung Chow
Häftad, 2020
815 kr
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In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a …
Statistical Design and Analysis of Stability Studies
Häftad, 2020
795 kr
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The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products …
Design and Analysis of Animal Studies in Pharmaceutical Development
Av Shein-Chung Chow, Jen-pei Liu
Häftad, 2020
815 kr
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"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and …
Advanced Statistics in Regulatory Critical Clinical Initiatives
Av Wei Zhang, Fangrong Yan m. fl.
Häftad, 2024
890 kr
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Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on …
Sample Size Calculations in Clinical Research
Av Shein-Chung Chow, Jun Shao m. fl.
Häftad, 2020
711 kr
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Praise for the Second Edition:"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics"This impressive book contains formulae for computing sample size …
Analytical Similarity Assessment in Biosimilar Product Development
Häftad, 2020
897 kr
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This book focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of …
Methodologies in Biosimilar Product Development
Av Sang Joon Lee, Shein-Chung Chow
Inbunden, 2021
3083 kr
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Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval …
Design and Analysis of Clinical Trials
Concepts and Methodologies
Av Shein-Chung Chow, Jen-Pei Liu
Inbunden, 2013
1898 kr
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Praise for the Second Edition:“...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best PracticesThe Third Edition of Design and Analysis of Clinical Trials provides …
Statistics in Drug Research
Methodologies and Recent Developments
Inbunden, 2002
4363 kr
Lägg i varukorg
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the …
Advanced Linear Models
Theory and Applications
Av Shein-Chung Chow, Song-Gui Wang
Inbunden, 1993
3168 kr
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This work details the statistical inference of linear models including parameter estimation, hypothesis testing, confidence intervals, and prediction. The authors discuss the application of statistical theories and methodologies to various linear models such as the linear regression model, the …
Statistical Design and Analysis in Pharmaceutical Science
Validation, Process Controls, and Stability
Av Shein-Chung Chow, Jen-pei Liu
Inbunden, 1995
2516 kr
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"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Innovative Methods for Rare Disease Drug Development
E-bok, 2020
963 kr
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In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because …
Innovative Methods for Rare Disease Drug Development
E-bok, 2020
942 kr
Lägg i varukorg
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because …
Methodologies in Biosimilar Product Development
Av Shein-Chung Chow, Sang Joon Lee
E-bok, 2021
881 kr
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Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval …
Methodologies in Biosimilar Product Development
Av Shein-Chung Chow, Sang Joon Lee
E-bok, 2021
910 kr
Lägg i varukorg
Methodologies for Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the mix-up use of interval …
Advanced Statistics in Regulatory Critical Clinical Initiatives
Av Shein-Chung Chow, Feng Chen m. fl.
E-bok, 2022
1052 kr
Lägg i varukorg
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on …
