PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

Recent years have shown a surge of population-based pharmacokinetics (PBPK) modeling and simulation within the pharmaceutical industry, and there has been strong support by global regulatory agencies for drug approvals. The positive impact that PBPK has brought to drug development has been clearly proven, saving considerable time and money while also providing the ability to ask and answer many “what if” questions. However, change can bring its share of doubt and skepticism, and for years the value of PBPK has not been fully understood. This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is an industrial and regulatory necessity in modern drug development.

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