Comprehensive support for your program at any stage
Our DMPK department provides comprehensive support for both early-stage and advanced discovery programs. We offer a wide range of standard in vitro assays and in vivo studies, and work closely with our clients to understand their specific needs, molding our approach around the project’s goals.
Our DMPK expertise allows for seamless integration of medicinal chemistry and pharmacology outputs. By generating comprehensive data and interpreting it through our knowledge of the chemistry space and with the added context of the animal’s physiology, we enable informed decision-making around compound design and selection.
We are known across the industry for providing an exceptional caliber of integrated project support. Client after client has chosen us not just for quick and precise execution of standard DMPK assays and studies, but also for the robustness of our feedback. We go beyond simply providing data; our team excels in guiding clients through the drug discovery process, offering valuable insights and solutions to their DMPK challenges. With our custom reporting of results, deep scientific expertise, fast turnaround time, and ability to provide integrated support, we are the ideal partner to help understand your drug’s properties.
Client
Testimonial
"The level of engagement, commitment, and dedication to the program that the entire team at Paraza has shown is impressive. The success to date is a reflection of that hard work, and we sincerely appreciate it."
Compliance
To facilitate hand-off of your preclinical data to the FDA or other regulatory bodies, our DMPK studies are conducted according to industry norms and FDA guidance documents. Additionally, in our commitment to animal welfare and ethical practices, we partner exclusively with laboratory animal facilities which are accredited by the CCAC and therefore held to high standards which are recognized internationally by organizations such as AAALAC International.
Tailored in vitro assays and in vivo studies
In close collaboration with our partners, we design and develop tailored in vitro assays and in vivo studies in various areas, including tolerability, multidose studies and surgical animal models. Whether we are working on standalone or integrated projects, our DMPK team serves as a dependable guide, simplifying your project’s journey through drug discovery and development, while adeptly navigating the complexities of pharmacokinetics.
In Vitro ADME
- Variety of in vitro assays suitable for both early-stage drug discovery and advanced compound profiling
- Cell permeability assays
- Metabolic stability assessments in microsomes, cytosol, hepatocytes, plasma, blood, and other matrices
- Protein binding measurement by equilibrium dialysis
- Solubility studies at various pHs, including biorelevant buffers
- Specialized procedures such as nuclear receptor assays, transporter studies, and cell viability assays are also available
Pharmacokinetics (PK) and In Vivo Studies
- Standardized and tailored study designs conducted in rodents and higher species within CCAC accredited facilities
- Single/multiple ascending dose, maximum tolerated dose and acute tolerability studies
- Rat surgical models for drug elimination pathway characterization
- Excretion studies in rodent and non-rodent species
- Formulation development for pre-clinical in vivo studies
Bioanalytical Solutions
- Quick turnaround for both small-molecule and large-molecule projects
- Bioanalysis of routine in vitro ADME assays and in vivo PK/PD samples from various tissues and biofluids
- In vitro and in vivo metabolite profiling in a variety of media and identification of metabolites using cold material
- Protein characterization and proteomics
- Broad range of more specialized capabilities including custom bioanalytical method development, small biomarker analysis, compound derivatization, and more
State-of-the art instrumentation
- QuantStudio qPCR system
- ABS2 Automated Blood Samplers
- Triple quadrupole LC‐MS/MS systems
- High‐resolution Q‐Exactive LC‐MS/MS systems
- UHPLC-DAD system
- Automated liquid handler (Beckman) for sample preparation
- OMNI Bead Ruptor Elite tissue homogenizer