【摘 要】
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Description:This symposium is designed to help biotech company scientists understand strategies for dose selection and justification in early development.Methods used to perform pharmacokinetic and ph
【机 构】
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Cognigen Corporation USA
【出 处】
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中国上海第七届国际新药发明科技年会
论文部分内容阅读
Description:This symposium is designed to help biotech company scientists understand strategies for dose selection and justification in early development.Methods used to perform pharmacokinetic and pharmacodynamic (PK/PD) modeling and simulations will be described,particularly in addressing the challenges of moving from pre-clinical to early clinical development and the design of phase Ⅱ studies.Strategies for using the results to ensure a successful development program and improving interactions with regulatory agencies will be emphasized.Brief case studies illustrating examples of successful strategies will be described.Suggestions for avoiding common mistakes and expensive delays during the implementation of PK/PD studies will also be provided.
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