DMPK Services

Pharmaron’s DMPK CRO services deliver comprehensive support for projects from early discovery to late-stage development, including:

Fee-for-service projects from early drug discovery through to registration
Investigational New Drug (IND), New Drug Application (NDA) and Biologics License Applications (BLA) packages
Integrated drug discovery
Modeling and simulation

Connect with a Scientific Expert

All DMPK services can incorporate strategic advice, input, and discussion of experimental design and data interpretation.

End-to-End Coverage from Discovery to Clinical Testing

Our expert teams have developed state-of-the-art DMPK services and facilities designed to comprehensively address every aspect of in vitro and in vivo testing across various animal species, along with clinical and non-clinical work during clinical development. This robust setup provides clients a streamlined one-stop-shop experience, enabling effective testing with consistent, high-quality data.

DMPK CRO discovery services

Pharmaron supports our clients’ drug discovery needs with high-quality but cost-effective in vitro data and in vivo pharmacokinetic services. Appreciating that these studies are at the heart of drug discovery decision-making, we offer these ADME studies with a delivery time of as little as 5 days. Our DMPK CRO division in the US provides the convenience of ordering standard services through our E-store. Discovery projects can also be conducted in an integrated, multi-disciplinary setup involving our computational chemistry, medicinal chemistry, and biology teams.

Regulatory DMPK services

Our extensive range of ADME studies includes Biopharmaceutics Classification System (BCS) studies, regulatory in vitro studies, metabolite profiling, and structural elucidation. Studies using radiolabeled test material to fully define the DMPK properties of a compound across different species are offered to complete the package.

Our regulatory affairs team brings extensive experience in project design and communication with regulatory bodies to maximize the success of IND, NDA, and BLA filings with authorities, including the FDA, NMPA, or EMA.

DMPK Services across Modalities

In addition to ADME studies for small-molecule compounds, support is available across all modalities, including protein degraders, peptides, antibody-drug conjugates (ADCs), and biologics, such as antibodies, fusion proteins, and multi-specific molecules. To enable work with these cutting-edge technologies, all ADME studies are supported by state-of-the-art bioanalytical departments within the DMPK CRO, ensuring industry-leading turnaround times and compliance with required legislation.

Modeling and Simulation

Our expertise also extends to integrating experimental data to predict human dose and pharmacokinetics. This includes the application of physiologically based pharmacokinetic (PBPK) modeling and simulation to aid molecule selection and guide clinical potential and trial design.

Pharmaron’s DMPK CRO Services Cover all Needs from Discovery to Clinical Phase

Discovery in vitro ADMET

Discovery in vivo PK

Regulatory in vitro ADMET

Regulatory in vivo PK

Radiolabeled Metabolism and Biodistribution

Integrated DMPK Solutions and Project Strategies

Integrated DMPK solutions and project strategies give our clients access to the expertise of our scientists, enabling efficient management of multiple DMPK components to accelerate drug discovery and development.

Explore the advantages of our integrated approach to DMPK, including:

Integrated in vitro and in vivo ADME
Integrated formulation and PK services
DMPK consultancy
Human PK and dose prediction, as well as preclinical species modeling via PBPK

Additionally, our integrated drug discovery services provide a collaborative approach driven by a multidisciplinary team of experienced drug hunters specializing in chemistry, DMPK, and biology.

20 Years of Successful ADME Studies

Pharmaron’s extensive experience and expertise in all aspects of DMPK science, including working with many different modalities, delivers high-quality data and interpretation for our customers.

PK studies in rodents and large animals performed last year.

DMPK packages delivered for filings to FDA, NMPA, and EMA.

of in vitro and in vivo projects are delivered within 5 days.

A scientists loads a droplet generator to prepare samples for digital PCR for biodistribution and shedding studies of cell and gene therapeutic products.

Supporting a Large Range of Modalities

Our team of expert scientists is equipped to handle DMPK projects across diverse modalities through specialized personnel, optimized assay techniques, and advanced bioanalytical equipment tailored to each modality’s unique requirements.

Cell and gene therapeutics: Biodistribution and viral shedding
Biologics: PK studies

Find more modality-specific resources:

Webinar: DMPK Assessment of ADCs
Webinar: DMPK Challenges and Strategies for Developing Protein Degrader Compounds
Webinar: Brain Penetration of Biologics
Webinar: Key ADME Insights for Oligonucleotide Drugs

A scientist programs an apricot automatic liquid handler to perform automated ADME studies

Accelerated Timelines through Optimized Work Processes

Our research facilities in China, the US, and the UK excel in the timely delivery of results through a highly optimized setup:

In-house bioanalysis makes sample shipping unnecessary
In-house colonies for selected animal species enable immediate study initiations.
A high grade of automation facilitates fast and reproducible results
Our smart compound management system, together with our chemistry labs and efficacy testing,g enables 1-week test cycles, including in vitro and in vivo data
A single-dose PK study (non-GLP) will be delivered within 5 days after the purchase order