Abstract
Abstract. The modern regulatory requirements for pharmaceutical development, stricter of requirements of medicinal products (MP) quality standards, the experience of manufacturers and development companies in terms of MP pharmaceutical development revealed need to create solutions that minimize the risk of medicinal product quality deviations, guaranteeing the release of effective and safe MP with the planned quality. The aim of these study is to form solutions for optimization of generic medicinal products pharmaceutical development process. For the study, according to the proposed algorithm, a generic drug in a liquid for inhalation dosage form was developed. The pharmaceutical development of MP according to created model contributes to reducing the financial and time costs of the developer company related to repeated research of PD, eliminating inconsistencies in the reproducibility and control of the technological process, maintaining the goals of the company's PQS in terms of the development and circulation of medicinal products, guaranteeing efficiency, safety and quality of the developed generic medicinal products.
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