Regulatory Perspective of Physiology based Pharmacokinetic (PBPK) Modeling
Introduction A molecule’s journey from its discovery cradle to the patient’s bedside is highly uncertain and often has a low probability of success. Substantiation of its safety and efficacy to cater to an unmet medical need involves a long span of time and investment of billions of dollars. In order to improve the efficacy of the drug development process, various strategies are designed that aim at eliminating molecules at the earliest stages that do not promise any therapeutic benefit. For…
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