Statistics In the Pharmaceutical Industry
portes grátis
Statistics In the Pharmaceutical Industry
Buncher, C. Ralph; Tsay, Jia-Yeong
Taylor & Francis Ltd
01/2023
496
Mole
Inglês
9781032477879
15 a 20 dias
920
Descrição não disponível.
Introduction to the Evolution of Pharmaceutical Products. Statistical Review and Evaluation of Animal Carcinogenicity Studies. The FDA and the IND/NDA Statistical Review Process. Clinical Trial Designs. Selecting Patients for a Clinical Trial. Statistical Aspects of Cancer Clinical Trials. Recent Statistical Issues and Developments in Cancer Clinical Trials. Design and Analysis of Testosterone Replacement Therapy Trials. Clinical Trials of Analgesic Drugs. Statistical Issues in HIV/AIDS Research. The Wonders of Placebo. Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice. Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective. Interim Analysis and Adaptive Design in Clinical Trials. A Regulatory Perspective on Data Monitoring and Interim Analysis. Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics. Phase IV Postmarketing Studies. The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry. Global Harmonization of Drug Development: A Clinical Statistics Perspective. Bridging Strategies in Global Drug Development. Design and Analysis Strategies for Clinical Pharmacokinetic Trials. Stability Studies of Pharmaceuticals. When and How to Do Multiple Comparisons. Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Interim Analyses;Ich E9;Sample Size Reestimation;Ich Guideline;Adaptive Design;Statistical Reviewers;FDA Statistician;Ich E6;Group Sequential Designs;Data Monitoring Committee;Case Control Study;Active Control Effect;Transgenic Mouse;Global Drug Development;False Negative Error;Noninferiority Trial;Institutional Review Board;Family Error Rate;Null Hypothesis;Foreign Clinical Data;Primary Null Hypothesis;Noninferiority Margin;Reference Interval;Positive Dose Response Relationship;Individual Bioequivalence
Introduction to the Evolution of Pharmaceutical Products. Statistical Review and Evaluation of Animal Carcinogenicity Studies. The FDA and the IND/NDA Statistical Review Process. Clinical Trial Designs. Selecting Patients for a Clinical Trial. Statistical Aspects of Cancer Clinical Trials. Recent Statistical Issues and Developments in Cancer Clinical Trials. Design and Analysis of Testosterone Replacement Therapy Trials. Clinical Trials of Analgesic Drugs. Statistical Issues in HIV/AIDS Research. The Wonders of Placebo. Active-Controlled Noninferiority/Equivalence Trials: Methods and Practice. Interim Analysis and Bias in Clinical Trials: The Adaptive Design Perspective. Interim Analysis and Adaptive Design in Clinical Trials. A Regulatory Perspective on Data Monitoring and Interim Analysis. Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics. Phase IV Postmarketing Studies. The Role of Contract Research Organizations in Clinical Research in the Pharmaceutical Industry. Global Harmonization of Drug Development: A Clinical Statistics Perspective. Bridging Strategies in Global Drug Development. Design and Analysis Strategies for Clinical Pharmacokinetic Trials. Stability Studies of Pharmaceuticals. When and How to Do Multiple Comparisons. Reference Intervals (Ranges): Distribution-Free Methods vs. Normal Theory. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Interim Analyses;Ich E9;Sample Size Reestimation;Ich Guideline;Adaptive Design;Statistical Reviewers;FDA Statistician;Ich E6;Group Sequential Designs;Data Monitoring Committee;Case Control Study;Active Control Effect;Transgenic Mouse;Global Drug Development;False Negative Error;Noninferiority Trial;Institutional Review Board;Family Error Rate;Null Hypothesis;Foreign Clinical Data;Primary Null Hypothesis;Noninferiority Margin;Reference Interval;Positive Dose Response Relationship;Individual Bioequivalence
