Development of generics
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Development of generics

Creation of generic drug equivalent to the selected analog

  • We select the generic drug based on the characteristics of manufacturing, state registration, scale of required preclinical and clinical studies taking into account the minimization of              development costs, and all types of studies.
  • We determine the optimal dosage form
  • We conduct: preclinical, toxicity and pharmacology studies in animals, bioequivalence studies, bioavailability assessment
  • We develop and validate methods of analysis of generic drug for normative documentation and for bioequivalence studies in clinical practice
  • We develop normative documentation (ND, experimental and industrial standing orders)
  • We implement pilot manufacturing for laboratory examination and clinical studies

In the development of innovative drug during formulation research, the pharmacokinetic profile of the future drug is determined.
In the course of development it is possible to create any dosage forms.