IN VITRO CORRELATION STUDY AND PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK) MODELING SIMULATION OF RIVAROXABAN 20 MG FILM-COATED TABLET THROUGH QUALITY BY DESIGN (QBD) METHOD
Bioequivalency (BE) study is a mandatory requirement by regulatory agencies to assess the similarity in the “rate and extent of drug absorption” between innovator and test product, particularly for obligatory BE molecules. This has led to the wide use of Quality by Design (QbD) method in generic pro...
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Format: | Theses |
Language: | Indonesia |
Online Access: | https://digilib.itb.ac.id/gdl/view/81105 |
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Institution: | Institut Teknologi Bandung |
Language: | Indonesia |