Электронная книга: Shayne Gad Cox «Drug Safety Evaluation»
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This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns– including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition Издательство: "John Wiley&Sons Limited"
ISBN: 9781119097402 электронная книга Купить за 27025.8 руб и скачать на Litres |
Другие книги автора:
| Книга | Описание | Год | Цена | Тип книги |
|---|---|---|---|---|
| Development of Therapeutic Agents Handbook | A comprehensive look at current drug discovery and development methods—and the roadmap for the future Providing both understanding and guidance in characterizing potential drugs and their… — John Wiley&Sons Limited, электронная книга Подробнее... | электронная книга | ||
| Clinical Trials Handbook | Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive… — John Wiley&Sons Limited, электронная книга Подробнее... | электронная книга |
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