Pharmacokinetics (PK) and In Vivo Studies

Comprehensive in vivo support for your program at any stage

Our team of PK experts and in vivo scientists offer standardized and tailored study designs in rodents and higher species. Non-GLP studies are conducted in CCAC accredited facilities. All PK data analyses are performed using Phoenix WinNonlin software.

Client
Testimonial

"I would like to thank you again for two years of a great collaboration between our two teams. Your dedication, hard work and expertise were instrumental to the success of our program, and we only have fond memories of our interactions. You certainly contributed to our success, and we look forward to the compound moving forward."

Pharmacokinetic studies in various species

Our refined sampling techniques and high-sensitivity analytical instruments allow us to collect minimal blood/fluid volumes per time point, per animal. A complete PK profile can be obtained from individual mice (serial microsampling) and from individual rats and guinea pigs. Moreover, several different matrices can be collected during a PK experiment to study the compound’s distribution profile and excretion pathways.  Our PK experts are available at every step to assist you in the design and execution of your in vivo study.

Available Species

  • Mouse 
  • Rats 
  • Guinea pigs
  • Beagle dogs (through partner)
  • Cynomolgus monkeys (through partner)

Routes Of Administration

  • Oral
  • Intravenous (bolus injection or continuous infusion)
  • Intramuscular
  • Subcutaneous (injection or osmotic pump) 
  • Intraperitoneal (injection or osmotic pump)
  • Intranasal
  • Intra-cannula
  • Additional routes of administration available upon request

Rat Surgical Models

  • Bile-Duct Cannulated (BDC) rats: 
  • Vascular cannulation in rats:
    • Carotid artery (rats and guinea pigs)
    • Jugular vein (rats and guinea pigs)
    • Mesenteric vein cannulated rats
  • Additional surgical models can be established upon request

Excretion studies in rodent and non-rodent species

Rodents can be housed in metabolic cages for urine and/or feces collection upon drug administration, permitting quantification of excretion in those matrices. Housing of non-rodent species in metabolic cages can also be performed on special demand.

Single/Multiple Ascending Dose (SAD/MAD), Maximum Tolerated Dose (MTD) and acute tolerability studies

These non-GLP studies are designed to assess the PK profile of your compound at various doses, evaluate the compound’s acute tolerability, and ultimately, optimize dosing regimens and formulation development. SAD studies provide valuable information for determining the optimal dosing regimen and supporting the delivery of high drug concentrations, while MAD studies are a vital precursor to multiday pre-clinical in vivo efficacy studies. Both can be combined with gross pathology observations and blood chemistry/hematology analysis to yield a comprehensive understanding of your compound’s pharmacokinetics, tolerability, and potential toxicities associated with repeated and increasing drug administrations.

Formulation development for pre-clinical in vivo studies

Our in vivo PK team has expertise in pre-clinical formulation development to support the profiling of your compounds across multiple species and routes of administration. Leveraging our knowledge of the various excipients, comprehension of the physicochemical properties of molecules, and understanding of excipient tolerability for the species and route of administration, we can propose judicious compositions that can enhance the delivery of the test material.

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If you want to learn more about the Paraza difference, contact us to discuss your specific needs.