The interchangeability of drugs from line items of pharmaceutical compliance and clinical efficiency and safety

Abstract

Questions of replacement of original medicines with generic are discussed. The sintesation of identical medicine is a complex challenge from the technological point of view. It is caused by distinctions in production of substances, influence of the variable pharmaceutical factors giving change of the size of particles, a different amorphous forms, a deviation of structure and quantitative content of impurity. Auxiliary substantion characteristics of a production process of ready dosage forms matter. Data on pharmacokinetic equivalence of each generic to original are necessary. For carrying out pharmacotherapy original medicine which receive as a result of the researches executed under the regulated protocol needs data on comparative therapeutic efficiency and shipping the generic of drugs.

Keywords

• оригинальное лекарство
• дженерик
• эквивалентность
• взаимозаменяемость
• эффективность
• безопасность
• original medicine
• generic
• equivalence
• interchangeability
• efficiency
• safety