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- W4241700708 abstract "The preclinical assessment of the safety of potential new pharmaceuticals represents a special case of the general practice of nonclinical safety assessment possessing its own peculiarities and special considerations and differing in several ways from the practice of toxicology in other fields. The successful operation of a safety assessment program in the pharmaceutical industry requires that four different phases of the product-related operation be simultaneously supported. These four phases of pharmaceutical product support, such as discovery support, Investigation New Drug (IND) support, clinical and registration support, and product support, constitute the vast majority of what is done by the safety assessment groups in the pharmaceutical industry. International conference on harmonization (ICH) clearly denotes what nonclinical studies are required to support clinical drug development. Minimum standards and requirements for safety assessment of new pharmaceuticals are established by the need to meet regulatory requirements for developing, and eventually gaining approval to market, the agent." @default.
- W4241700708 created "2022-05-12" @default.
- W4241700708 date "2016-10-31" @default.
- W4241700708 modified "2023-09-23" @default.
- W4241700708 title "STRATEGY AND PHASING FOR NONCLINICAL DRUG SAFETY EVALUATION IN THE DISCOVERY AND DEVELOPMENT OF PHARMACEUTICALS" @default.
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- W4241700708 doi "https://doi.org/10.1002/9781119097440.ch26" @default.
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