Biopharmaceutics, pharmacokinetics, formulations.

Biopharmaceutics, IVIVC, bioequivalence studies, PBPK simulation

Specialize in biopharmaceutics, pharmacokinetics, pharmacometrics PK/PD, PBPK, IVIVC, statistics: Work in R&D group Focus on physical properties of the API such as solubility, PKa, log P to predict solubility profile within physiological pH range.  Investigate PK/PD, facilitate for preparing a normal and special formulation especially solid extended release dosage form, solid orally disintegration tablets.-  Analyze clinical data, give suggestion for modifications for trial formulations to meet clinical requirements. Prediction of bioavailability, probability to pass bioequivalence test of compounds that follow linear and non linear pharmacokinetics. Cooperate with analytical group for dissolution test. Analyze disolution test results, applying IVIVC correlation (convolution and deconvolution). Support regulatory group for NDA, ANDA submision. Investigate biological aspect and pharmacokinetic, pharmacodynamic behaviors. Drug metabolism profiles of the target compound, distribution, metabolism of compound in blood and specific tissues. Drug transporter through intestinal tract, first pass effect of compound. Determine in vitro in vivo correlation, run simulation using commercial software to specify dissolution profiles, plasma concentration of test drug from trial formulations.  Predict clinical results, calculate sample size, procedures, experimental design for bioequivalence studies, efficacy study and other clinical studies.

PK study, bioequivalence, biopharmaceutics, IVIVC

Participated in editing Vietnamese Pharmacopedia, worked in QC lab. Validated analytical methods.