In vitro Absorption, Distribution, Metabolism and Elimination (ADME) and in vivo Pharmacokinetic (PK) evaluation to ascertain drug like characteristics of compounds is now been increasingly realized as standards that can determine a drugs failure or success rate in the subsequent processes. GVK BIO conducts pharmacokinetic screening studies including half-life, biodistribution, bioavailability and safety evaluation. LC-MS/MS based bio-analytical methods are developed to identify and quantify test articles and metabolites in blood, urine and other biological fluids/ tissues.
ADME profiling is provided on the following two platforms:
 In vitro ADME
In vitro ADME studies helps in optimization of pharmacokinetic characteristics of a drug candidate, identify the metabolic pathways and provide valuable inputs for the design of in vivo studies. We offer both standardized as well as customized assays as per Sponsor’s requiremen for ADME parameters.
- Physicochemical studies
- pKa
- LogD/ LogP
- Solubility (Thermodynamic/ Kinetic)
- Chemical stability at different pH
- Absorption/ Distribution Assays
- PAMPA
- Caco2 or MDCK (Unidirectional/ Bidirectional)
- Pgp efflux
- Protein binding (ultrafiltration and equilibrium dialysis)
- Metabolic stability
- Microsomal Stability (rat, human, etc.,)
- Hepatocyte Stability
- Metabolite identification
- Biological stability (plasma, serum, blood, simulating fluid)
- CYP450 Assays
- CYP inhibition (CYP 1A2 , CYP 2C9, CYP 2C19, CYP 2D6, CYP 3A4)
- Mechanism based inhibition
- Half life determination/IC50 determination
- CYP pathway identification
- CYP450 /metabolite identification
- Bioanalysis:
UV/ Fluorescence/ LC-MS/MS
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In vivo PK
We provide a full range of preclinical pharmacokinetics and DMPK services in small animals to prioritize and select drug candidates. GVK BIO has expertise in performing surgical techniques in laboratory animals.
- In-Life Studies:
- Single/ Multiple Dose Pharmacokinetics (Rats, Mice, Guinea pigs, Rabbits)
- Cannulation (jugular, carotid and femoral and bile)
- Various Routes of Administration (PO, IV, IP, SC, IM, Topical, IT, Ocular , Infusion etc)
- Toxicokinetics
- Tissue Distribution studies
- In vivo Blood Brain Barrier Studies
- PK/PD relationship studies
- Pharmacokinetic Analysis of Non-clinical Studies (WinNonlin)
- Bioanalysis:
GVK BIO has experience, competency and technology in solving complex analytical problems relating to method development, validation and sample analysis. We provide fast and efficient method development for quantitative measurement of compounds in biological fluids by chromatographic and mass spectrometric techniques.
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