Design of non-clinical safety

In 1975 an EU Directive (75/318/EEC) required each member state to ensure the submission of safety and efficacy for marketing authorisation. Good laboratory practice (GLP) became the principle of non-clinical testing on pharmaceutical products and the requirement of a GCP standard in conducting clinical trials. It stated that all phases of clinical investigation, including bioavailability and bioequivalence studies shall be designed, implemented and reported in accordance of GCP (75/318/EEC, B.1.1). 

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. 

Table 3.1 Objectives of the industiy survey Strategies and approaches for designing non-clinical safety evaluation progranunes for phannaceutical products of biotechnology ...

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... 

Other activities that fall within the area of postmarketing surveillance require input from, if not handling by, those responsible for clinical drug safety. These may include observational (non-interventional) studies, which may be retrospective or prospective, and other projects specifically designed to investigate a safety issue. 

The design and the execution of safety pharmacology studies are focused upon the safety of human volunteers and patients in clinical trials. ICH S7A and may be soon S7B strive for effective integration of safety pharmacology results with those of the non-clinical (toxicology) and clinical safety databases. 

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