Pharmaceutical development should include, as a minimum, the following elements: definition of the target quality profile of the drug (QTPP) in relation to quality, safety and efficacy, taking into account, for example, route of administration, dosage form, bioavailability, potency and stability; identification of potential critical quality indicators (CQAs); thus, those characteristics of the drug that affect product quality should be the object of study and control; determination of critical indicators of the quality of the medicinal substance, auxiliary substances, as well as the choice of the type and quantity of auxiliary substances for the production of products of the required quality; choice of method, justification of the appropriate technological process; determination of the control strategy.