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Regulatory Perspective of Physiology based Pharmacokinetic (PBPK) Modeling

in Pharmaceutical Articles

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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GCC Pharma Regulatory Affairs Summit

GCC Pharma Regulatory Affairs Summit is a unique event for professionals responsible for pharma companies’ legal and regulatory issues in the GCC; The Summit will feature discussions between professionals and regulators on issues which the industry faces every day: timely reaction to legislative amendments, drug registration, introduction and application of new requirements and concepts. The conference will give a full picture of the specifics of regulating the pharma market in the GCC region: UAE, Kingdom of Saudi Arabia, Bahrain, Kuwait,…

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