DMPK
At Sai Life Sciences, as part of our DMPK strategy, we integrate in vitro ADME, in vivo pharmacokinetics, and comprehensive metabolite profiling with mechanistic drug–drug interaction assessments encompassing both CYP-mediated metabolism and transporter pathways. In addition, qualitative PK/PD modelling and translational human dose projections are incorporated to generate a robust, data-driven evidence package that supports IND-enabling submissions. This integrated framework enables confident, evidence-based go/no-go decisions while advancing high-quality candidates toward clinical development.
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18+ years of experience in delivering high-quality DMPK services
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150 global clients currently working with us
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High-throughput ADME screening facility with full integration on automated platforms to support physchem, metabolism and cell permeability assays
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> 2,500 PK studies in 2026
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45,000 square feet dedicated ADME/PK facility, scalable to growing needs
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120+ member scientific team
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Dedicated biotransformation group
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Dedicated team to support New Approach Methodologies including Organ on Chip methods
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Co-located with medicinal chemistry, biology, in vivo pharmacology, and toxicology
Our Capabilities
In Vitro ADME
Comprehensive ADME suites and integrated packages covering physicochemical properties, metabolism, enzyme kinetics, drug–drug interactions, cell permeability, and transporter studies. Our state-of-the-art facilities leverage advanced automation seamlessly integrated into routine workflows. We currently have the capacity to process over 1,400 compounds per month within our Tier I ADME panel, including solubility, LogD, microsomal and hepatocyte clearance (CLint), fraction unbound (fu), plasma stability, and permeability assessments.
In Vivo Pharmacokinetics
Multi-species pharmacokinetic (PK) parameters are evaluated using WinNonlin-based non-compartmental analysis to characterize intravenous and oral PK profiles. This approach enables the determination of key PK parameters, including plasma clearance (CL), volume of distribution at steady state (Vss), bioavailability (F), and half-life (t½), thereby providing comprehensive insights into absorption, distribution, metabolism, and excretion (ADME) characteristics.
Metabolite Identification & Profiling
Advanced LC-HRMS coupled with UV techniques for metabolite characterization, structural elucidation, and pathway analysis.
Translational PK/PD Modeling
Predictive modeling and simulation to estimate human dose, optimize exposure, and inform clinical study design.
Complex In Vitro Models
3D spheroids and organ-on-chip models to enable human-relevant prediction of hepatic clearance and drug-induced liver injury.
Safety Pharmacology
Integrated early safety pharmacology to identify cardiac, mitochondrial, cholestatic, and nuclear receptor–mediated risks. Key capabilities include manual patch clamp, high-content imaging, and Seahorse assays.
Discovery-to-Development Integration
Early input into medicinal chemistry and toxicology programs to support rational design and accelerated candidate nomination.
Our Capabilities
In Vitro ADME
Comprehensive ADME suites and integrated packages covering physicochemical properties, metabolism, enzyme kinetics, drug–drug interactions, cell permeability, and transporter studies. Our state-of-the-art facilities leverage advanced automation seamlessly integrated into routine workflows. We currently have the capacity to process over 1,400 compounds per month within our Tier I ADME panel, including solubility, LogD, microsomal and hepatocyte clearance (CLint), fraction unbound (fu), plasma stability, and permeability assessments.
In Vivo Pharmacokinetics
Multi-species pharmacokinetic (PK) parameters are evaluated using WinNonlin-based non-compartmental analysis to characterize intravenous and oral PK profiles. This approach enables the determination of key PK parameters, including plasma clearance (CL), volume of distribution at steady state (Vss), bioavailability (F), and half-life (t½), thereby providing comprehensive insights into absorption, distribution, metabolism, and excretion (ADME) characteristics.
Metabolite Identification & Profiling
Advanced LC-HRMS coupled with UV techniques for metabolite characterization, structural elucidation, and pathway analysis.
Translational PK/PD Modeling
Predictive modeling and simulation to estimate human dose, optimize exposure, and inform clinical study design.
Complex In Vitro Models
3D spheroids and organ-on-chip models to enable human-relevant prediction of hepatic clearance and drug-induced liver injury.
Safety Pharmacology
Integrated early safety pharmacology to identify cardiac, mitochondrial, cholestatic, and nuclear receptor–mediated risks. Key capabilities include manual patch clamp, high-content imaging, and Seahorse assays.
Discovery-to-Development Integration
Early input into medicinal chemistry and toxicology programs to support rational design and accelerated candidate nomination.
Facilities, Equipment, and Technical Capabilities
Our DMPK laboratories are equipped with high-sensitivity LC-MS/MS systems, HR-MS, UPLC platforms, automated sample preparation systems, and fully integrated in vitro and in vivo ADME/PK suites. This infrastructure supports rapid, reproducible bioanalysis, metabolite profiling, and modeling—ensuring precise, regulatory-compliant outputs from early discovery through development.
Frequently Asked Questions
Yes. We conduct in vitro ADME assays including microsomal stability, hepatocyte clearance, and Caco-2 permeability to assess drug-like properties early in discovery. Integrated workflows and real-time data sharing with chemistry and biology teams support rapid iteration and informed candidate selection.
Our bioanalytical platforms include HR-MS, high-sensitivity LC-MS/MS systems, UPLC, and automated sample preparation technologies. We perform quantitative analysis of drugs and metabolites in biological matrices, supporting in vitro ADME assays, PK profiling, and bioavailability studies. Methods are developed and validated in compliance with regulatory guidelines.
Yes. Our team conducts pharmacokinetics and pharmacodynamics studies using validated and custom-developed disease models, integrating data to build predictive models that guide dose selection and therapeutic strategy. Advanced bioanalytical and modeling tools correlate drug exposure with efficacy and safety outcomes to support IND-enabling studies.
DMPK data are integrated through a real-time collaborative workflow. Early ADME and PK insights on stability, clearance, and permeability are shared directly with chemists and biologists, guiding structure optimization, SAR development, and assay design. Shared digital platforms and program management ensure transparency and alignment.
Yes. We perform in vitro and in vivo Met ID studies supported by HR-MS, LC-MS/MS, and UPLC systems. These studies characterize metabolic pathways, identify major and minor metabolites, and assess potential safety risks, enabling early optimization and reduced attrition.
Yes. Sai Life Sciences offers NAMs-based DMPK assays, including an in-house developed 3D spheroid system. We provide metabolic stability evaluation for small molecules and large molecules such as PROTACs, as well as multiparametric DILI prediction assays using 3D spheroids and organ-on-chip models.