News

In the following, we would like to update you on current changes in the regulatory framework (OECD, ICH and others), inform you on upcoming congresses (including where you can meet us in person) and add information on the company and recent novelties.

“In our own case”

Shift to new research strategies in preclinical drug development

Over the last decade, a shift in paradigms was initiated, focussing on the development, validation and regulatory acceptance of non-animal testing strategies in toxicology. The Netherlands National Committee for the protection of animals used for scientific purposes (NCad) issued an opinion paper on objectives and transition strategies. The complete dossier can be assessed here:   ncad-opinion-transition-to-non-animal-research
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Dates / Congresses

Legislative change

OECD Guideline 414 Update

OECD Guideline 414 (Prenatal developmental toxicity study) was recently (25 Jun 2018) updated and now includes additional endpoints to increase the possibility of detecting endocrine disrupting chemicals.  
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Worth knowing from the authorities

Drug Safety Mail 2018-66

On 11 Nov 2018, the Arzneimittelkommission der deutschen Ärzteschaft (AKdÄ) issued a Drug Safety Mail on severe and long-lasting side effects of fluorochinolone antibiotics on muscles, joints and nervous system based on information from the German BfArM.  
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From the science community

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