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Review
. 2021 Jan;109(1):47-50.
doi: 10.1002/cpt.2064. Epub 2020 Oct 26.

Precision Dosing: An Industry Perspective

Richard W Peck  1
Affiliations
Review

Precision Dosing: An Industry Perspective

Richard W Peck. Clin Pharmacol Ther. 2021 Jan.
No abstract available

PubMed Disclaimer

Conflict of interest statement

Richard Peck is an employee and stockholder of the pharmaceutical company F. Hoffman‐La Roche.

Figures

Figure 1
Figure 1
The relationship of individual and population therapeutic windows for drugs with (a) a wide population‐level therapeutic window, (b) no population‐level therapeutic window, and (c) a narrow population‐level therapeutic window. In each panel the therapeutic windows for 10 representative patients on the x‐axis are illustrated with minimum effective dose (green bar), maximum tolerated dose (red bar), the population therapeutic window (gray box), and a population dose (blue line). There is no population dose or therapeutic window in b. In c even the narrow dose window considered acceptable for the whole population is below the minimum effective dose or above the maximum tolerated dose for some patients.
Figure 2
Figure 2
Decision tree and flow chart for implementation of a precision dosing paradigm in drug development. *When emerging data suggest the need to switch from the current “one‐dose‐for‐all” to precision dosing development the exact point of entry to the precision dosing paradigm is dependent on the extent of prior clinical development and available data.
See this image and copyright information in PMC

References

    1. Vinks, A.A. , Peck, R.W. , Neely, M. & Mould, D.R. Development and implementation of electronic health record‐integrated model‐informed clinical decision support tools for the precision dosing of drugs. Clin. Pharmacol. Ther. 107, 129–135 (2020). - PubMed
    1. Maloney, A. A new paradigm. “Learn—learn more”; Dose‐exposure‐response at the center of drug development and regulatory approval. Clin. Pharmacol. Ther. 102, 942–950 (2017). - PubMed
    1. Schuck, R.N. , Pacanowski, M. , Kim, S. , Madabushi, R. & Zineh, I. Use of titration as a therapeutic individualization strategy: an analysis of Food and Drug Administration‐approved drugs. Clin. Transl. Sci. 12, 236–239 (2019). - PMC - PubMed
    1. Xolair [prescribing information]. (Novartis, East Hanover, NJ, 07936‐1080) <https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl...> Accessed July 8, 2020.
    1. Gammagard liquid [prescribing information]. (Baxter Healthcare Corporation, Westlake Village, CA, 2012) <https://www.fda.gov/media/70812/download> Accessed July 8, 2020.

MeSH terms

Substances