A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.

A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.

On this paper, a particular case for bioequivalence analysis of oral formulations is mentioned. Drug formulations with completely different types of lively moieties (e.g., free base and salt) might yield completely different dissolution traits and, thus, differ in absorption at elevated gastric pH. Nevertheless, routine bioequivalence trials utilizing topics with regular gastric pH (i.e., ~ […]

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Evaluating the bioequivalence of metronidazole tablets and analyzing the effect of in vitro dissolution on in vivo absorption based on PBPK modeling.

Evaluating the bioequivalence of metronidazole tablets and analyzing the effect of in vitro dissolution on in vivo absorption based on PBPK modeling.

Metronidazole, a BCS class I , could possibly be waived primarily based on the BCS rules, thus enabling in vitro dissolution knowledge as a surrogate of BE research. Nevertheless, the impression of dissolution profiles of metronidazole tablets on the in vivo efficiency has by no means been studied systematically. So the purpose of the current research was to […]

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Verification of the Field Productivity and Bioequivalence of a Medicinal Plant ( Polygonum multiflorum) Developed Using an In Vitro Culture Method

Verification of the Field Productivity and Bioequivalence of a Medicinal Plant ( Polygonum multiflorum) Developed Using an In Vitro Culture Method

Polygonum multiflorum Thunb. is a perennial plant that belongs to Polygonaceae. Root tissues are the primary plant elements used as medicinal herbs in Korean oriental medication. The P. multiflorum tuber is well-known for its medicinal properties in Korean oriental medication, and it accommodates a lot of helpful substances (secondary metabolites of emodin, 2,3,5,4′-tetrahydroxystilbene-2-O–β-d-glucoside (TSG), and many others.) which […]

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Prediction of Fasted and Fed Bioequivalence for Immediate Release Drug Products using Physiologically based Biopharmaceutics Modeling (PBBM)

Prediction of Fasted and Fed Bioequivalence for Immediate Release Products using Physiologically based Biopharmaceutics Modeling (PBBM)

Bioequivalence research are an integral a part of scientific pharmacology technique for growth. Physiologically primarily based biopharmaceutics modeling (PBBM) is usually a useful device to evaluate potential bioequivalence dangers and predict the end result of bioequivalence research. On this examine, GastroPlus™ was used for digital bioequivalence (VBE) evaluation of 6 case research which incorporates 4 […]

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