NCE DP
BCS Class Ⅳ drugs
Sampling Peff Papp Similarity to the original study original research drug -5.818 1.52 100.0%(standard of reference) Products of Manufacturer A -5.791 1.62 **106.6%** qualified batch of Manufacturer B -5.767 1.71 ...
Ciprofloxacin
Experimental conditions Controlexperiment Samples 1 Samples 2 Bionic Membrane Raytor Bio-Flux Membrane Raytor Bio-Flux Membrane Raytor Bio-Flux Membrane Supply side pH 6.5 buffer pH 6.5 buffer（20% ethanol） pH 6.5 buffer（20% ethanol） Receiving side pH 7.4 ...
Excipients
Experimental conditions Pure API (control experiment) Reference preparation Text preparation Bionic Membrane Raytor Bio-Flux Membrane Raytor Bio-Flux Membrane Raytor Bio-Flux Membrane Supply side pH 6.5 buffer pH 6.5 buffer pH ...
Prediction of Food effect (FE) of Drugs in the Human Body
Experimental conditions Fasting Conditions Fed conditions Physiological model/spectral conditions pH shift model /Accurate algorithm pH shift model /Accurate algorithm Gastric Physiological conditions Fasted Simulated Gastric Fluid(pH 3.0) Fasted Simulated Gastric Fluid(pH 6.0) ...
BCS Ⅲ Class Drugs
Experimental conditions 0 mmol/L SDS 10 mmol/L SDS 20 mmol/L SDS Bionic membrane Bio-Flux membrane Bio-Flux membrane Bio-Flux membrane Supply side FaSSIF 0 level simulation FaSSIF 0 level simulation FaSSIF ...
Increasing the dosage of a drug
Experimental design The pH-shift model in Raytor NCE DP The pH-shift model in Raytor NCE DP Experimental conditions A team B team Physiological model/Spectral conditions pH shift model/Accurate Algorithm pH ...
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