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Legislative Measures for In Vitro–In Vivo Correlations and Pharmacokinetic Modeling

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Patenting Nanomedicines

Abstract

Worldwide, the regulation and governance of nanomedicine (nanopharmaceuticals and nano-enabled devices) derived from nanoscience and Nanotechnology research is regarded as one of the most discussed sector. The legislative bodies recommend comparative pharmacokinetic and mass balance studies along with platform stability testing to ensure the clinical translation of preclinical development. In this chapter, an urgent need of a code of conduct for responsible in vitro–in vivo correlations and pharmacokinetic modeling has been raised to govern responsible nanomedical innovation. The non-availability of updated and transparent scientific and statistical data is highlighted as missing pieces in nanomedicine regulation. Additionally, a detailed account of computational approaches employed for in vitro–in vivo along with the requirement of their synergy with the experimental data to provide modular solutions has been considered to comply with regulatory framework.

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Authors and Affiliations

  1. Department of Pharmacy and Pharmacology, University of the Witwatersrand, 7 York Road, Parktown 2193, Johannesburg, South Africa

    Viness Pillay, Yahya E. Choonara, Pradeep Kumar, Valence M. K. Ndesendo & Lisa C. du Toit

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  1. Viness Pillay
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  2. Yahya E. Choonara
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  4. Valence M. K. Ndesendo
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  5. Lisa C. du Toit
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Correspondence to Viness Pillay .

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  1. , Faculty of Health Sciences, University Fernando Pessoa, Rua Carlos da Maia 296, Cacif, Porto, 4200-150, Portugal

    Eliana B. Souto

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Pillay, V., Choonara, Y.E., Kumar, P., Ndesendo, V.M.K., du Toit, L.C. (2012). Legislative Measures for In Vitro–In Vivo Correlations and Pharmacokinetic Modeling. In: Souto, E. (eds) Patenting Nanomedicines. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-29265-1_3

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