Drug Metabolism and Pharmacokinetics (DMPK)
Adgyl Lifesciences provides integrated DMPK services, including in vitro ADMET and in vivo PK studies, to support programs from hit-to-lead, lead optimisation and preclinical development. Our experienced team designs and executes fit-for-purpose ADMET assays alongside comprehensive PK evaluations in both rodent and non-rodent models, ensuring alignment with client-specific project needs.
Our in vitro capabilities cover key ADMET parameters, including physicochemical characterisation, permeability, metabolism and metabolite profiling, drug-drug interaction liability evaluations, protein binding, and cytotoxicity enabling early risk identification and informed candidate selection. We support ADME studies in both screening and development phases, with rapid turnaround times - on average 5 days for discovery-stage studies.
For in vivo studies, PK and radiolabelled DMPK investigations are performed in rodent and non-rodent species to evaluate bioavailability, tissue distribution, mass balance, excretion, and brain penetration. Our expertise includes a wide range of cannulation techniques (jugular, femoral, carotid, portal vein, and bile duct) and diverse dosing routes (intravenous, oral, intramuscular, subcutaneous, intranasal, endotracheal, dermal, and intradermal). In addition, we provide toxicokinetic analysis using validated Phoenix WinNonlin 8.0, ensuring high-quality data to support IND-enabling programs.
In Vitro ADMET Capabilities Include:
-
Kinetic and Thermodynamic solubility in:
- Aqueous buffers at different pH
- Biorelevant media (SGF, FaSSIF, and FeSSIF)
-
Lipophilicity (log D and log P):
- Octanol-water / phosphate buffer partitioning
- Aqueous buffers at different pH
- Biorelevant media (SGF, FaSSIF and FeSSIF)
- Plasma and blood
- Dose formulation
- Intrinsic permeability-PAMPA
- Mono and bi-directional transport: Caco-2 and MDCK cells
- In presence and absence of efflux drug transport inhibitors (P-gp, and BCRP)
-
Metabolic stability / intrinsic clearance in:
- Liver and other tissue microsomes
- S9 fractions
- Hepatocytes
-
Metabolite identification in sub cellular fractions, hepatocytes and in vivo samples:
- Cross species metabolite profiling to determine relevant tox species
- Direct glucuronidation in liver microsomes using Uridine Diphosphate Glucuronic Acid (UDPGA)
- Reactive metabolite identification using Glutathione (GSH) trapping assay
- CYP inhibition (single point, IC50) using human liver microsomes (HLM)
- Time dependent CYP inhibition in HLM (IC50 shift, Ki and Kinact)
- CYP reaction phenotyping (purified rCYPs/human liver microsomes)
-
CYP induction in plateable human hepatocytes:
- 1A2, 2B6 and 3A4 enzyme activity
- mRNA analysis
- cytotoxicity
- Plasma protein binding
- Microsomal/tissue homogenate protein binding
- Brain tissue binding
- Blood-to-plasma concentration ratio (RBC partitioning)
- HepG2 cell line
- Hepatocytes
In Vivo PK Capabilities Include:
(rodent and non-rodent species)
- Absolute and relative bioavailability assessment
- Cassette and discrete dosing
- Brain penetration in vivo
- 14C-labeled DMPK Studies in rodents:
- --- Mass Balance / Excretion balance
- --- Tissue distribution
- --- Ocular PK study in rabbits
- --- Biliary excretion study
- --- Metabolite profiling
- PK/ PD studies
- Toxicokinetics:
- --- Allometric scaling: FIH dose projections and human PK predictions
- Validated WinNonlin Phoenix software for data analysis
- Pre-formulation/ Formulation Development for PK studies:
- --- Development of formulations for low-solubility compounds using pH, co-solvents, or complexation approaches (for IV, PO, SC etc.,)
- --- Formulation development using excipients suitable for repeated dose studies
- --- Solubility assessment by HPLC or LC MS/MS
- --- Bioavailability optimisation via salt forms, lipid-based formulations, prodrugs, or micronisation
- --- Analytical method development and validation to support dose confirmation analysis.
- Absolute and relative bioavailability assessment
- Cassette and discrete dosing
- Brain penetration in vivo
-
14C-labeled DMPK Studies in rodents:
- Mass Balance / Excretion balance
- Tissue distribution
- Ocular PK study in rabbits
- Biliary excretion study
- Metabolite profiling
- PK/ PD studies
-
Toxicokinetics:
- Allometric scaling: FIH dose projections and human PK predictions
- Validated WinNonlin Phoenix software for data analysis
-
Pre-formulation/ Formulation Development for PK studies:
- Development of formulations for low-solubility compounds using pH, co-solvents, or complexation approaches (for IV, PO, SC etc.,)
- Formulation development using excipients suitable for repeated-dose studies
- Solubility assessment by HPLC or LC-MS/MS
- Bioavailability optimisation via salt forms, lipid-based formulations, prodrugs, or micronisation
- Analytical method development and validation to support dose confirmation analysis.
SCIENTIFIC PARTNERSHIP
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your DMPK studies.
what people ask
Frequently Asked Questions
What DMPK services do you offer?
Integrated in vitro ADMET and in vivo PK studies to support lead optimisation and preclinical development.
Do you perform studies for discovery-stage programs?
Yes—we actively support discovery-stage projects with rapid, fit-for-purpose ADMET screening (typical TAT ~5 days) to enable early risk assessment and informed candidate selection.
What is your turnaround time for in vitro studies?
Typically, ~5 days for discovery-stage screening studies.
What species do you work with?
Rodent and non-rodent species, including specialised models.
How do your studies add value?
They enable early decision-making, risk mitigation, and acceleration toward IND readiness.
