منابع مشابه
Assessment of cognitive safety in clinical drug development
Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design an...
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Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been ab...
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Clinical laboratory measurements are an integral component of most drug studies for two major reasons, firstly to act as an efficacy endpoint in monitoring the success or otherwise of therapy and secondly to ensure patient safety on any new drug or reformulation. The pharmaceutical industry rarely employs physicians and scientists with expertise in clinical laboratory medicine. As such, there i...
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Despite advancements in genetics, chemistry, and protein engineering, recent years have seen fewer approvals of new drugs, increases in development costs, and high-profile drug withdrawals. This article focuses on technologic methods for improving drug development efficiency. These technologies include high-content cell screening, expression profiling, mass spectroscopy, mouse models of disease...
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ژورنال
عنوان ژورنال: Bulletin de l'Académie vétérinaire de France
سال: 2008
ISSN: 0001-4192
DOI: 10.4267/2042/47926