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Industrial Pharmacy: The Way to Create a Product (Monograph Review)
Pharmaceutical Chemistry Journal ( IF 0.8 ) Pub Date : 2020-08-01 , DOI: 10.1007/s11094-020-02235-6
S. I. Kolesnikov , A. L. Khokhlov , A. E. Miroshnikov , N. O. Pozdnyakov

The recently published monograph “Industrial Pharmacy: The Way to Create a Product” is devoted to topical problems in this field. The unique interdisciplinary features of drug development require specialists in this industry that possess a high level of qualification and knowledge in many fields such as chemistry, biology, medicine, pharmacy, toxicology, regulatory science, marketing, economics, law, information technology, etc. The monograph presents modern approaches to the implementation of each stage in the creation of a medicinal product: initial search, research and development, production and registration, marketing and sales, and medical use. The monograph highlights the legislative and regulatory documents needed as guides at each stage of the technology cycle. The second part of the monograph provides particular guidelines for technology transfer of drug production and the preparation of industrial production design. Actual significant aspects of many sciences and disciplines and technological processes are collected in one place in this monograph, making it a valuable practical guide.

中文翻译:

工业药学:创造产品的方式(专着评论)

最近出版的专着《工业药学:创造产品的方法》专门探讨了该领域的热点问题。药物开发独特的跨学科特征需要该行业的专家在化学、生物学、医学、药学、毒理学、监管科学、市场营销、经济学、法律、信息技术等许多领域拥有高水平的资格和知识。该专着介绍了药品生产各个阶段实施的现代方法:初步检索、研究和开发、生产和注册、营销和销售以及医疗用途。该专着强调了在技术周期的每个阶段作为指南所需的立法和监管文件。专论的第二部分为药品生产的技术转让和工业生产设计的准备提供了具体的指导方针。许多科学和学科以及技术过程的实际重要方面都集中在这本专着的一个地方,使其成为有价值的实用指南。
更新日期:2020-08-01
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