Advanced Statistics in Regulatory Critical Clinical Initiatives
portes grátis
Advanced Statistics in Regulatory Critical Clinical Initiatives
Chen, Feng; Yan, Fangrong; Zhang, Wei; Chow, Shein-Chung
Taylor & Francis Ltd
05/2024
307
Mole
9780367609955
Pré-lançamento - envio 15 a 20 dias após a sua edição
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1 Introduction, 2 Complex Innovative Design, 3 Validation Strategy for Biomarker guided Precision/Personalized Medicine, 4 Model-Informed Drug Development, 5 Real-world data and real-world evidence, 6 AI/ML in Medical Research and Drug Development, 7 Challenges in Cancer Clinical Trials, 8 Statistical Methods for Assessment of Biosimilars, 9 Statistical Methods for Assessment of Complex Generic Drugs, 10 Rare Diseases Drug Development
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
FDA;Biopharmaceutical Statistics;Clinical Trials;Biosimilar Products;Analytical Similarity Assessment;Interim Analysis;Umbrella Trial;Reference Product;Rare Diseases Drug;Basket Trial;Adaptive Trial Design;Adaptive Design;BPCI Act;Disease Risk Score;Adaptive Enrichment Design;NTI Drug;Target Mediated Drug Disposition;PB Pk Model;Non-medical Switch;TMDD;Biomarker Negative Patients;Biomarker Positive Patients;Adaptive Seamless Trial Design;Fieller Confidence Interval;Fundamental Bioequivalence Assumption;Breakthrough Therapy Designation;PS;Smart
1 Introduction, 2 Complex Innovative Design, 3 Validation Strategy for Biomarker guided Precision/Personalized Medicine, 4 Model-Informed Drug Development, 5 Real-world data and real-world evidence, 6 AI/ML in Medical Research and Drug Development, 7 Challenges in Cancer Clinical Trials, 8 Statistical Methods for Assessment of Biosimilars, 9 Statistical Methods for Assessment of Complex Generic Drugs, 10 Rare Diseases Drug Development
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
FDA;Biopharmaceutical Statistics;Clinical Trials;Biosimilar Products;Analytical Similarity Assessment;Interim Analysis;Umbrella Trial;Reference Product;Rare Diseases Drug;Basket Trial;Adaptive Trial Design;Adaptive Design;BPCI Act;Disease Risk Score;Adaptive Enrichment Design;NTI Drug;Target Mediated Drug Disposition;PB Pk Model;Non-medical Switch;TMDD;Biomarker Negative Patients;Biomarker Positive Patients;Adaptive Seamless Trial Design;Fieller Confidence Interval;Fundamental Bioequivalence Assumption;Breakthrough Therapy Designation;PS;Smart
