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ADME/DMPK Studies
Unlock the Full Potential of Your Drug Discovery Program with Medicilon's Expertise
ADME/DMPK (Absorption, Distribution, Metabolism, and Excretion/Drug Metabolism and Pharmacokinetics) studies are vital to ensuring the safety, efficacy, and viability of drug candidates.
Medicilon offers integrated services spanning in vitro and in vivo assays, providing end-to-end support from early discovery through clinical trials.
Why ADME/DMPK Studies Matter
Medicilon’s tailored approach ensures seamless transition through these stages, supporting your IND/NDA submissions with robust, regulatory-compliant data.
STAGE ONE
Early Discovery
Profile discovery to lead candidates for optimal physicochemical properties and target engagement.
STAGE TWO
Preclinical Development
Refine dosing strategies and predict human responses.
STAGE THREE
Clinical Trials
Reduce risks with actionable data on metabolism and excretion.
In Vitro ADME Assays
Enhancing early-stage evaluations
Our in vitro assays prioritize early-stage efficiency, enabling:
Rapid Screening
Lead Optimization
Structural Refinement
Key In Vitro Services
Gain predictive insights into your compound’s pharmacokinetics and toxicity
In vitro ADME data reduce late-stage failures, prioritize promising candidates, and ensure robust early-stage decision-making.
Plasma Protein Binding & Stability
Understand how your drug interacts in biological matrices.
Transporter Studies
Evaluate membrane drug transport mechanisms
(P-gp/BCRP/OATs/OCTs/MATEs/BSEP/MRPs).
Enzyme Interaction Studies
CYP450 inhibition, induction, and phenotyping.
Metabolic Stability
Liver microsomes, S9, hepatocyte studies.
Permeability Testing
Estimate absorption and Blood-Brain Barrier penetration.
Optimize your drug development with Medicilon’s tailored in vitro ADME solutions
Preclinical In Vivo ADME Studies
Real-World Insights
In vivo ADME studies capture complex biological interactions, making them indispensable for:
Bioavailability & Dosing Strategies
Tissue Distribution & Excretion Pathways
Regulatory Filings
Key In Vivo Services
Gain predictive insights into your compound’s PK, distribution, and excretion
By integrating in vivo assessments, we provide accurate, actionable data that bridges the gap between preclinical research and clinical application.
Pharmacokinetic Assessments
- Multi-species and Multi-cycle screening and PK/PD correlations.
- Drug-drug interaction evaluations in vivo.
Surgical Models
- Intravenous cannulation and infusion pumps.
- Bile duct cannulation for detailed pharmacokinetic studies.
Specialized Techniques
- Ultrasound-guided biopsies (e.g., liver and muscle).
- Cassette dosing for high-throughput screening.
Tissue Distribution and Excretion Studies
- Blood-brain barrier permeability and tissue imaging using radiolabeled compounds.
- Metabolite identification and excretion pathway analysis.
Administration Routes
- Diverse methods including intravenous, oral, intraperitoneal, transdermal, and intramuscular.
ADME/DMPK Strengths
Built for precision, backed by expertise
Custom Solutions
Tailored studies to match your project’s unique needs
Expert Teams
Over 20 years of experience delivering reliable data
Global Presence
State-of-the-art facilities in China and the US
Regulatory Compliance
IND/NDA-ready packages aligned with global standards
Partner with Medicilon to accelerate your drug discovery
Case Studies
Proven Results with Medicilon
TOP5300
A Breakthrough in Infertility Treatments
Medicilon evaluated the preclinical ADME/Tox profile of TOP5300, a follicle-stimulating hormone receptor agonist, demonstrating excellent safety and pharmacokinetics.
ARD-2128
Advancing Cancer Therapies
Through detailed PK studies, Medicilon supported the development of ARD-2128, a PROTAC-based AR degrader, showing superior plasma stability and bioavailability.
Frequently Asked Questions
Have questions about ADME/DMPK Studies?
Why are ADME/DMPK studies critical before IND submission?
How do in vitro assays complement in vivo studies
In vitro screens rapidly flag metabolism or transporter liabilities; in vivo PK/PD then validates those findings in whole-animal systems for translational accuracy.
Which ADME assays does Medicilon offer?
ADME studies evaluate absorption, distribution, metabolism, and excretion, ensuring effective therapeutic concentrations while minimizing toxicity. Plasma-protein binding, CYP450 inhibition/induction, metabolic stability (microsomes, hepatocytes, S-9), permeability (Caco-2, PAMPA) and specialty in vivo PK models.
Can Medicilon support PBPK modeling?
Yes. Our DMPK scientists build PBPK models to predict human exposure scenarios and guide first-in-human dose selection.
What role do in vitro assays play in toxicity prediction?
In vitro assays detect toxicity mechanisms early, reducing reliance on animal studies and highlighting safer candidates.
What sets Medicilon’s program apart from other preclincal CROs?
An end-to-end workflow under one roof (chemistry ➜ in vitro ➜ in vivo ➜ bioanalysis), AI-assisted PK/PD analytics, and SEND-formatted data packages for FDA/NMPA/OECD.
Your Trusted Partner in ADME/DMPK Research
From early discovery to IND-enabling studies, Medicilon’s integrated solutions and expert teams are here to support you at every step of drug development.