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Releasing the Human Spirit in Developing Drugs

Increasing Clinical Pharmacokinetics Productivity

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Abstract

A common problem in drug development is that highly trained people become trapped in doing the work of their respective discipline without taking individual responsibility for the most important questions. ‘Getting the dosage regimen right’ is a fundamental problem in drug development that is often not well performed. The experience described here transformed a department from completing required clinical pharmacokinetic studies to focusing on the most important questions in dosage regimen design that did not have a unique solution. Elements of the story include vision, quality, best practice, automation, transformation and impact. Productivity was increased by 81% within 2 years by one measure and there was a substantial positive financial impact.

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Notes

  1. 1The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements

The authors wish to acknowledge Christine Alvey, Howard Bockbrader, Rebecca Boyd, Richard Brown, Paula Burger, Francoise Chanoine, Brian Corrigan, Peter Lockwood, Mark Milad, David Mitchell, Arnab, Mukerjee, Stephen Olson, Daniele Ouellet, Paul Siedlik, Kanak Singh, Lloyd Whitfield, and Elizabeth Zegarac, as they were instrumental in bringing about the changes described above. Rita Criswell and Willi Foster facilitated the changes described. The authors conducted this work as full-time employees of Parke Davis and, subsequently Pfizer Inc.

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Authors and Affiliations

  1. Pfizer Global Research and Development, Ann Arbor, Michigan, USA

    J. Robert Powell, Edward J. Randinitis, Jack A. Cook & Richard L. Lalonde

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  1. J. Robert Powell
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  2. Edward J. Randinitis
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  3. Jack A. Cook
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  4. Richard L. Lalonde
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Correspondence to J. Robert Powell.

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Powell, J.R., Randinitis, E.J., Cook, J.A. et al. Releasing the Human Spirit in Developing Drugs. Int J Pharm Med 18, 13–17 (2004). https://doi.org/10.2165/00124363-200418010-00005

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  • DOI: https://doi.org/10.2165/00124363-200418010-00005

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