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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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Editorial: FDA Approval of a New Cannabis-based Drug ‘Epidiolex’ Shocks the Pharmaceutical Market

in Editors' Picks/Pharmaceutical Articles
Epidiolex by GW Pharma

Epidiolex, the catchy name of a new drug to treat complex seizures, has generated a wave of controversy around the medical world. Federal advisers recommended the approval of the first prescription drug in which the main component is cannabidiol (CBD), a natural cannabis’ derivative with low addictive power. This drug would be approved just for the treatment of seizures caused by the Lennox-Gastaut and Dravet syndromes, Complex Tuberous Sclerosis and Infant Spasms. Epidiolex represents a new hope for people living…

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