Summary of Workshop on Use of Data Developed during Drug Development for Read across to Environmental Analyses
- PDF / 31,143 Bytes
- 2 Pages / 612 x 792 pts (letter) Page_size
- 7 Downloads / 169 Views
Klaus Olejniczak Federal Institute for Drugs and Medical Devices, Germany Richard T. Williams Pfizer, USA Thomas Kühler Medical Products Agency, Sweden Per Spindler BioLogue, University of Copenhagen, Denmark
Correspondence Address Per Spindler, DVM, MSc, EMBA, Director, BioLogue, University of Copenhagen, Blegdamsvej 3A, DK-2200 Copenhagen N, Denmark (e-mail: [email protected]).
201
Summary of Workshop on Use of Data Developed During Drug Development for Read Across to Environmental Analyses
THE ISSUE The chemistry; primary and secondary pharmacodynamics (eg, mechanism of action and pharmacological actions unrelated to the therapeutic effect); pharmacokinetics (absorption, distribution, metabolism, and excretion); and in vitro and animal toxicology of human pharmaceuticals are extensively studied during preregistration discovery and development. Effectively utilizing data that support the medical use of a pharmaceutical to answer environmental questions or guide the development of environmental data has potential benefits that include minimizing (eg, not duplicating) animal testing and enhancing the focus and effectiveness of the environmental risk assessment. This workshop was designed to highlight the state of the science and identify opportunities and research needs for mechanistic ecotoxicology and reading across taxonomic lines to support environmental risk assessment (ERA) of human pharmaceuticals.
2.
3.
4.
5.
WORKSHOP CONCLUSIONS 1. Read across is inherently accepted and presently is used in the ERA when nonclinical data indicate potential for hormonal disruption (mechanism of
6.
action), antibiotic action (mechanism of action), or genotoxicity (toxicological property). Metabolism and analytical methods are also used in the process of ERA. In some cases, human metabolism is key data in the assessment of environmental exposure. The workshop did not conclude on reading across taxonomic lines to support ERA of human pharmaceuticals. It is felt that comparison across taxonomic lines needs more scientific scrutiny, most likely on a specific, case-by-case basis. From a scientific perspective, it is recommended that all relevant data be taken into account when an ERA is conducted, including physicochemical properties, primary and secondary pharmacodynamics, toxicology, metabolism, excretion, degradability, and persistence of the drug substance or relevant metabolites. From a regulatory perspective, it is recognized that the opportunity to utilize these data varies with the stage of ERA development (1). Important information for the ERA might be located in other parts of the dossier. The ERA report in the European Union is part of the regional-specific portion of the Common Technical Document (Part 1.6 in the European Union) and therefore separated from other parts with research data. As such, it may present a logistic challenge to applicants and reviewers to assess data. Reading across might save research resources and
Drug Information Journal, Vol. 41, pp. 201–202, 2007 • 0092-8615/2007 Printed in the US
Data Loading...
