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. 2023 Aug;12(8):771-774.
doi: 10.1002/cpdd.1274. Epub 2023 Jun 23.

Improving the Efficiency of Clinical Pharmacology Studies

Thomas M Polasek  1   2 , Virna Schuck  3
Affiliations

Improving the Efficiency of Clinical Pharmacology Studies

Thomas M Polasek et al. Clin Pharmacol Drug Dev. 2023 Aug.
No abstract available

Keywords: clinical pharmacology; drug development; first-in-human; model-informed drug development; new drugs.

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References

    1. Wouters OJ, McKee M, Luyten J. Estimated research and development investment needed to bring a new medicine to market, 2009-2018. JAMA. 2020;323(9):844-853.
    1. Kraft WK. Clinical pharmacology and the best use of public research investment. Clin Pharmacol Ther. 2022;111(6):1185-1188.
    1. Parasrampuria DA, Benet LZ. Inclusion of placebos and blinding for ascending dose first-in-human studies and other underpowered phase 1 studies has not been justified and on balance is not useful. Basic Clin Pharmacol Toxicol. 2015;117(1):44-51.
    1. Snyder BD, Rowland A, Polasek TM, Miners JO, Doogue MP. Evaluation of felodipine as a potential perpetrator of pharmacokinetic drug-drug interactions. Eur J Clin Pharmacol. 2014;70(9):1115-1122.
    1. Brown K, Etrouth S, Jayachandran P, et al. Diversity in clinical pharmacology: a call to action. Clin Pharmacol Ther. 2023;113(3):483-485.

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