A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development
| Autor: | Elizabeth Donald, Vicente Nogues, Kamil Nahas, Peter Stei, Matthias Festag, Kathryn Chapman, Lynne Waterson, Kirsty Quinn, Kev Somers, Jean-Luc Delongeas, Sally Robinson, Claudia Stark, Nigel Pickersgill, Sophie Kervyn, David Dreher, Deborah Ockert, Sally Old, Ann Lampo |
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| Rok vydání: | 2008 |
| Předmět: |
Pharmaceutical drug
Drug medicine.medical_specialty Drug Industry medicine.medical_treatment media_common.quotation_subject Pharmacology Toxicology Drug overdose Computer Communication Networks Toxicity Tests medicine Animals Humans media_common.cataloged_instance European Union European union Intensive care medicine media_common Clinical Trials as Topic Dose-Response Relationship Drug business.industry Data Collection General Medicine Legislation Drug medicine.disease Acute toxicity Clinical trial Pharmaceutical Preparations Drug development Research Design Lethality Drug Overdose business |
| Zdroj: | Regulatory Toxicology and Pharmacology. 50:345-352 |
| ISSN: | 0273-2300 |
| DOI: | 10.1016/j.yrtph.2007.11.009 |
| Popis: | Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an evidence-based review of acute toxicity studies and assessed the value of the data generated. Preclinical and clinical information was shared on 74 compounds. The analysis indicated acute toxicity data was not used to (i) terminate drugs from development (ii) support dose selection for repeat dose studies in animals or (iii) to set doses in the first clinical trials in humans. The conclusion of the working group is that acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe. |
| Databáze: | OpenAIRE |
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