Drug Metabolism & Pharmacokinetics
Regulatory Services
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Bioanalytical method development for various in-vivo and in-vitro DMPK studiesDRF/BA/001 (Non-GLP)
This assay quantifies analyte of interest in different matrix samples of in-vivo and in-vitro studies using suitable chromatography techniques like HPLC, LCMS, GC.
Model
Using suitable chromatography techniques like HPLC, LCMS, GCEnd Point
Robust bioanalytical method developed to estimate analyte concentration in in-vitro and in-vivo samples precisely and accurately.Relevance
To quantify analyte of interest in different matrix samples of in-vivo and in-vitro studies.
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Pharmacokinetics studyDRF/BA/002
This assay evaluates the pharmacokinetic parameters of analyte required to know drug absorption, distribution, metabolism and excretion profile.
Animal Model
RodentEnd Point
Pharmacokinetic parameters like AUC, Cmax, Tmax, Vd, Cl etc.Relevance
To evaluate the pharmacokinetic parameters of analyte required to know drug absorption,distribution,metabolism and excretion profile.
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Bioavailability studyDRF/BA/003 (Non-GLP)
This assay identifies the bioavailability of drug/analyte using suitable animal model.
Animal Model
Rodents/RabbitEnd Point
% Bioavailability will be evaluatedRelevance
To identify the bioavailability of drug/analyte
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Biodistribution studyDRF/BA/004 (Non-GLP)
This assay identifies the biodistribution of drug/analyte in different tissues using suitable animal model.
Animal Model
Rodents/RabbitEnd Point
Drug distribution in different tissue will be evaluatedRelevance
To identify the biodistribution of drug/analyte in different tissues
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In-Vivo metabolism and excretion studiesDRF/BA/005 (Non-GLP)
This assay identifies the drug metabolite formation or clearance of analyte using suitable animal model.
Animal Model
RodentsEnd Point
Drug metabolic identified and drug clearance will be evaluatedRelevance
To identify the drug metabolite and drug clearance
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In-Vivo drug-drug interaction studiesDRF/BA/006 (Non-GLP)
This assay identifies drug to drug interaction when taken simultaneously using suitable animal model.
Animal Model
RodentsEnd Point
Drug inhibition and drug induction potentialRelevance
To identify drug to drug interaction when taken simultaneously
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Permeability studiesDRF/BA/007 (Non-GLP)
This assay identifies drug permeability through cell based and non-cell based models.
Cell Model
CaCo-2 cells, MDCK, PAMPA (non-cell based)End Point
Drug permeability properties.Relevance
To identify in-vitro drug permeability
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Cytochrome P450 Inhibition/Interaction studiesDRF/BA/008 (Non-GLP)
This assay identifies drug to drug interaction when taken simultaneously using suitable chromatography techniques like HPLC, LCMS, GC.
Model
Using suitable chromatography techniques like HPLC, LCMS, GC, CYP Inhibition kitsEnd Point
Drug inhibition potential will be evaluated.Relevance
To identify drug to drug interaction when taken simultaneously
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Plasma protein binding studiesDRF/BA/009 (Non-GLP)
This assay identifies binding of drug to plasma protein using ultracentrifugation, ultrafiltration or rapid equilibrium dialysis method and suitable chromatography techniques like HPLC, LCMS, GC.
Model
Using Ultracentrifugation, Ultrafiltration or Rapid equilibrium dialysis method and suitable chromatography techniques like HPLC, LCMS, GCEnd Point
Drug plasma protein binding will be evaluated, bound and unbound fraction of drug will be evaluated.Relevance
To identify binding of drug to plasma protein
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Dermal permeabilityDRF/BA/010 (Non-GLP)
This assay identifies drug permeability through animal skin model or or artificial membranes using franz diffusion cell and suitable chromatography techniques like HPLC, LCMS, GC.
Animal Model
Animal skin model or Artificial membraneEnd Point
Drug permeability potential will be evaluated.Relevance
To identify drug permeability potential through animal skin
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Bioanalytical method validationDRF/BA/011
This assay validates analytical methods for accurate analyte measurement.
Model
Using suitable chromatography techniques like HPLC, LCMS, GCEnd Point
Selectivity, Specificity, Matrix effect, Calibration curve and range, Accuracy and precision, Carry-over, Dilution integrity, StabilityRelevance
Confirms that the method used for the analysis is reliable, reproducible and fit for its intended purpose
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ToxicokineticsDRF/BA/012
This assay determines systemic exposure of compound during toxicology assessment using suitable animal model.
Animal Model
Rodents/RatEnd Point
Quantification of analyte/(s) in biological matrixRelevance
Determine systemic exposure of compound during toxicology assessment.