Accelerating CNS Drug Development
Accelerating CNS Drug Development
Kurtz, N.; Murphy, M.; Carta, A; Sramek, J.; Cutler, Neal R.
John Wiley and Sons Ltd
01/1998
194
Dura
Inglês
9780471981282
0471981281
440
This volume covers drugs available for disorders of the central nervous system. This book examines options on the design of clinical trials and questions the need for prolonged testing in some areas, based on evidence from real examples. It includes examples for the pharmaceutical industry.
Why do we want to accelerate development?; what causes development to stagger?; how much animal data is necessary before exposure to man?; toxicity; efficacy in animal models: is it necessary?; the role of PK/bioavailability studies; dose models: animal models can be poorly predictive of dose; useful in some indications, but not in others; surrogate endpoints; how do you prove the drug is useful? How do you choose the correct dose?; role of the investigator study - does this accelerate development?; must every trial be a placebo-controlled, double-blind, parallel group design?; review of clinical trial design; rationale for selection of initial doses (based on preclinical NTEL or Phase I studies in healthy subjects); methodology of the bridging study: definition of the MTD, recommended design; regulatory issues; are two or more pivotal efficacy studies necessary?; carcinogenicity trials - are long-term studies necessary?; how many years of human exposure are required?; FDA registry parts E and F: have they made a difference?; role of post-marketing data in drug development; concluding remarks on drug development.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
This volume covers drugs available for disorders of the central nervous system. This book examines options on the design of clinical trials and questions the need for prolonged testing in some areas, based on evidence from real examples. It includes examples for the pharmaceutical industry.
Why do we want to accelerate development?; what causes development to stagger?; how much animal data is necessary before exposure to man?; toxicity; efficacy in animal models: is it necessary?; the role of PK/bioavailability studies; dose models: animal models can be poorly predictive of dose; useful in some indications, but not in others; surrogate endpoints; how do you prove the drug is useful? How do you choose the correct dose?; role of the investigator study - does this accelerate development?; must every trial be a placebo-controlled, double-blind, parallel group design?; review of clinical trial design; rationale for selection of initial doses (based on preclinical NTEL or Phase I studies in healthy subjects); methodology of the bridging study: definition of the MTD, recommended design; regulatory issues; are two or more pivotal efficacy studies necessary?; carcinogenicity trials - are long-term studies necessary?; how many years of human exposure are required?; FDA registry parts E and F: have they made a difference?; role of post-marketing data in drug development; concluding remarks on drug development.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
