Design of non-clinical safety evaluation programmes

Company strategies for designing non-clinical safety evaluation programmes Results of a CMR International survey... 

There is a variety of strategies used by the industry when designing non-clinical safety evaluation programmes for pharmaceutical products of biotechnology, which is consistent with the case-by-case approach considered appropriate for these products. 

To identify the strategy of companies when designing non-clinical safety evaluation programmes for pharmaceutical products of biotechnology. 

Ten of the respondent companies were in the top 15 companies by pharmaceutical R D expenditure in 1996, and 25 were in the top 40 companies (Scrip, 1996). The respondents collectively had considerable personal experience - they had, in total, been involved with designing non-clinical safety evaluation programmes for more than 180 pharmaceutical products of biotechnology, and 62% had a minimum of 6 years relevant experience. 

Designing Non-clinical Safety Evaluation Programmes Survey Results Assessment of carcinogenic potential... 

Designing non-clinical safety evaluation programmes The view of the clinician John Lipani... 

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