2019
DOI: 10.30895/1991-2919-2019-9-1-28-33
|View full text |Cite
|
Sign up to set email alerts
|

Regulatory Requirements of the European Medicines Agency for Evaluation of Bioequivalence of Modified-release Medicinal Products

Abstract: There are no specific requirements and recommendations in the Russian Federation for evaluation of bioequivalence of modified-release medicinal products. Until recently, modified-release products were regulated in a similar manner as immediate-release products, which is unacceptable considering the active ingredient release profile and its pharmacokinetics. The modified release characteristics require a more complex approach to the assessment of equivalence of generic medicines as compared with the reference p… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...

Citation Types

0
0
0

Publication Types

Select...

Relationship

0
0

Authors

Journals

citations
Cited by 0 publications
references
References 4 publications
0
0
0
Order By: Relevance

No citations

Set email alert for when this publication receives citations?