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...
Saved in:
Main Author: | Novia, Jessica |
---|---|
Format: | Theses |
Language: | Indonesia |
Online Access: | https://digilib.itb.ac.id/gdl/view/81105 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Institution: | Institut Teknologi Bandung |
Language: | Indonesia |
Similar Items
-
Comparison of rivaroxaban concentrations between Asians and Caucasians and their correlation with PT/INR
by: Ng HOT, et al.
Published: (2020) -
Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers
by: Rojanasthien N., et al.
Published: (2014) -
Pharmacokinetics and bioequivalence study of the two 20-MG quinapril hydrochloride tablet formulations in healthy Thai male volunteers
by: Noppamas Rojanasthien, et al.
Published: (2018) -
Quality by design (QbD)-based crystallization process development for the polymorphic drug tolbutamide
by: Thirunahari, S., et al.
Published: (2014) -
IMPLEMENTATION QUALITY BY DESIGN (QBD) CONCEPT IN SOLID ORAL MODIFIED RELEASE GENERIC PRODUCT DEVELOPMENT
by: Prima Pinastika A., Francisca