Theory Of Drug Development

During drug development, pharmaceutical companies test new molecules and assemble the necessary evidence required by regulatory agencies to show that a drug is safe and effective. This book presents a quantitative framework for evaluating the efficiency of the drug development process as well as the [...]
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During drug development, pharmaceutical companies test new molecules and assemble the necessary evidence required by regulatory agencies to show that a drug is safe and effective. This book presents a quantitative framework for evaluating the efficiency of the drug development process as well as the quality of the resulting evidence supporting clinical efficacy. Using this framework, the author formally evaluates a variety of issues that arise in drug development, from surrogate variables, targeted therapies, and interim analysis to seamless phase II/III designs.