Nonclinical Drug Development Services and Toxicology Consultancy
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Experimental Toxicology Services (ETS) Nederland BV, based in Zutphen, the Netherlands, is an independent, privately-owned company that provides nonclinical drug development services. The company is managed by Henk Tennekes, Ph.D, a highly experienced consultant in toxicology.
Non-clinical study monitoring for the pharmaceutical and agrochemical industries
ETS was established in Switzerland in 1992 and has provided nonclinical drug development services to many leading companies in the pharmaceutical and agrochemical industry. Henk Tennekes provides high quality study monitoring services for outsourced (non-clinical) studies in close collaboration with the study sponsor, usually R&D departments of pharmaceutical and biotech companies.
Reports and toxicology summaries for regulatory submissions
Henk Tennekes also prepares expert reports and toxicology summaries of non-clinical studies as part of nonclinical drug development services for regulatory submissions. In-sourcing and staff training courses can be organised by Henk Tennekes upon consultation.
Henk Tennekes has frequently been requested to provide nonclinical drug development services when a client’s internal resources were considered to be insufficient or temporarily overstretched.
Nonclinical drug development services
Nonclinical drug development services include contract research organisation (CRO) selection, study design and protocol review of non-clinical studies, study monitoring, and data analysis and review of draft and final reports.
Study monitoring by Henk Tennekes ensures that pivotal non-clinical studies on the critical path are in safe hands; Henk Tennekes has successfully managed the general toxicology department of a major European contract research laboratory (RCC, Research and Consulting Company in Itingen, Switzerland) from 1986 to 1992.
Publications on oncology subjects
Henk Tennekes is an expert in oncology and has published authoritative papers in leading scientific journals:
- Henk Tennekes and V.A. Gretton (2008). Hazard and risk assessment of chemical carcinogenicity within a regulatory context. Submitted for publication in: Cancer Risk Assessment: Carcinogenesis from Biology to Standards Quantification, John Wiley and Sons, Hoboken, NJ 07030-5774.
- Henk Tennekes, C. Gembardt, M. Dammann and B. van Ravenzwaay (2004). The stability of historical control data for common neoplasms in laboratory rats: adrenal gland (medulla), mammary gland, liver, endocrine pancreas and pituitary gland. Regulatory Toxicology and Pharmacology 40, 18-27
- Henk Tennekes, W. Kaufmann, M. Dammann and B. van Ravenzwaay (2004). The stability of historical control data for common neoplasms in laboratory rats and the implications for carcinogenic risk assessment. Regulatory Toxicology and Pharmacology 40, 293-304
- Henk Tennekes, B. van Ravenzwaay, and H. W. Kunz (1985).Quantitative aspects of enhanced liver tumour formation in CF-1 mice by dieldrin. Carcinogenesis 6, 1457-1462
- Henk Tennekes, L. Edler, and H. W. Kunz (1982). Dose-response analysis of the enhancement of liver tumor formation in CF-1 mice by dieldrin. Carcinogenesis 3, 941-945
- Henk Tennekes, A. S. Wright, K. M. Dix, and J. H. Koeman (1981). Effects of dieldrin, diet and bedding on enzyme function and tumor incidence in livers of male CF-1 mice. Cancer Research 41, 3615-3620
Preparation of regulatory documentation
Nonclinical drug development services include data interpretation and evaluation (report preparation), preparation of expert reports, toxicology summaries, contributions to Investigator’s Brochures (IB), Investigational New Drugs (IND), New Drug Applications (NDA), and the preparation of manuscripts for scientific journals (ghostwriting).