Abstract
Strategies for designing nonclinical safety evaluation programs for pharmaceutical products of biotechnology, the types of studies conducted, and the reasons for their inclusion were identified through a questionnaire-based survey of 37 pharmaceutical and biotechnology companies. The majority of respondents were already using International Conference on Harmonization (ICH) guidance, then available only in draft, when choosing which studies to include; a high proportion also sought interaction with regulators at an early stage of program design.
The survey revealed that a variety of strategies have been adopted by the industry, consistent with the case-by-case approach considered necessary for these products. Not all safety evaluation studies have been conducted as part of a scientific strategy, however, some have been undertaken solely to meet perceived regulatory expectations or specific requests. Although overall experience of testing biotechnology products in animal models of disease, homologous systems, and transgenic animals was limited, personnel from both biotechnology and pharmaceutical companies were keen to incorporate such alternative studies in the future.
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