Nathan Teuscher and Nikunjkumar Patel , Certara03.07.17
Modeling and simulation (M&S) has already profoundly impacted drug development and formulation. It is used in 90% of all U.S. Food and Drug Administration (FDA) drug approvals. M&S can influence every phase of the drug development process, including informing commercial decisions about the benefits of bringing a specific drug to market. It can be employed to compare the safety and efficacy of drug candidates; select dose and dose regimen; and identify potential drug-drug and drug-food interactions. M&S can be used in lieu of specific clinical trials, and of importance to those involved in drug formulation, leveraged to demonstrate virtual bioequivalence and obtain biowaivers.
Formulation science is an iterative process that can benefit from the ‘predict, learn, confirm and apply’ paradigm underpinning M&S. That paradigm can support and strengthen the overall formulation strategy and inform the numerous alternate formulations that will be developed throughout the development cycle. Formulation selection can profoundly impact drug release, absorption, and metabolism, altering the drug’s pharmacokinetic profile and its pharmacodyn
Formulation science is an iterative process that can benefit from the ‘predict, learn, confirm and apply’ paradigm underpinning M&S. That paradigm can support and strengthen the overall formulation strategy and inform the numerous alternate formulations that will be developed throughout the development cycle. Formulation selection can profoundly impact drug release, absorption, and metabolism, altering the drug’s pharmacokinetic profile and its pharmacodyn
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