Pharmacokinetic studies – PK Studies are key activities of early drug development. Our Pharmacokinetic services (PK services) can be exploratory, or can be more extensive. Understanding the pharmacokinetic properties (PK) of a test article is an essential component of drug discovery and development programs.
GVK BIO conducts regular PK studies and can also customize it based the requirements of the clients.Pharmacokinetic PK Studies and toxicokinetic analyses are key activities of early drug development. Thoroughly understanding the DMPK of a potential clinical candidate can have a huge impact on the success of a drug discovery program.
PK and TK studies provide useful and required information that informs no effect levels (NOEL), human equivalent doses (HED), and pharmacokinetic/pharmacodynamic (PK/PD) drivers. Carrying out PK studies enables the determination of PK parameters such as AUC, clearance, volume of distribution, half-life, Cmax, and Cmin.
GVK BIO offers a comprehensive solution for non-GLP PK studies that includes quick turnaround PK screening for lead optimization or formulation evaluation, and full PK programs that encompass the in-life portion, bioanalysis and PK modeling. Studies can be conducted in rodents and nonrodents, including ferrets, dogs, mini pigs, and nonhuman primates (NHPs).
Bioanalysis is performed for determination of small molecules in blood, plasma, serum, CSF, or tissues. Our state of the art bioanalytical capabilities include LC-MS/MS – AB SCIEX 5500 and robotic sample prep systems. Biologic drugs may be determined using ELISA or qPCR assays.
In vitro Metabolism
Characterize your compound’s ADME properties and potential drug interactions with an in vitro assessment from our metabolism team. You get expert study design and data interpretation giving you specific insight to help in the development of your non-clinical and clinical strategy.
Drug-transporter interaction models
Select the best candidate and meet the latest expectations of regulatory agencies by assessing drug transporters key to drug disposition. Our widely published scientists coupled with expert analytical capabilities walk you down a path that helps you reach your drug development milestones with confidence.
Understand your compound’s absorption potential by assessing membrane permeability with our Caco-2 in vitro absorption team. Caco-2 cell monolayers are an excellent model for assessing oral permeability and the investigation of absorption mechanisms involving P-gp and BCRP.
Plasma Protein Binding and Blood Cell Partitioning
Assess your compound’s distribution within animals or humans. Determine in vitro and ex vivo protein binding and blood cell partitioning with our team who utilizes equilibrium dialysis, ultrafiltration and blood cell partitioning techniques.
Drug-drug interaction models
Get an early read on the drug-drug interaction potential of your candidate while minimizing the use of animals with our in vitro andex vivo metabolism assays. Our team routinely performs CYP450 induction, inhibition & identification, cross species comparison, and metabolite identification & profiling.
Determine the chemical reaction metabolizing your drug and identify the associated CYP enzyme to better predict and understand the potential for drug-drug interactions.
Establish the percentage of your compound’s metabolism over time using microsomes and/or hepatocytes. As your partner we will compare and assess your compound’s metabolic rate and metabolites generated across species to help you project human PK values.
In vivo Radiolabeled ADME
Combine your compound’s critical safety assessment with our unrivaled capability to design and conduct radioactive studies. Our team utilizes multiple isotopes while executing mass balance, placental transfer and quantitative whole-body autoradiography studies with specialized routes of administration.
Metabolite Identification and Profiling
Integrate your compound’s metabolite analysis across nonclinical and clinical study designs to improve your strategic methodology. With hundreds of metabolite identification assessments per year, our team of experts utilize the latest technology providing critical data to help you make informed decision faster.
Nonclinical PK Screening
Predict the metabolism and PK of your drug candidate in humans with flexible study designs incorporating in-life and/or analytical support. Our fast study starts, established in-house colonies and efficient study execution provide you a cost effective solution.
Rapid PK Screening
The iterative nature of in vivo PK screening requires rapid cycle times with changing priorities. We have built a team of experienced scientists with facilities and processes designed specifically to meet these challenging requirements.
From standard screening to more complex studies, our team of experienced team can also assist in designing the best strategy and protocols customized to suit any drug discovery program. Rapid study initiations facilitated by our maintenance supply of rodents and colonies of non-rodent species along with standardized protocols and fully integrated LC-MS/MS bioanalysis of PK samples, including small volume samples, result in better data faster
GVK BIO ensures safe and efficacious dosage regimens through the application of pharmacokinetic / pharmacodynamic principles and the determination of drug serum concentrations. The iterative nature of in vivo PK services requires rapid cycle times with changing priorities. We have built a team of experienced scientists with facilities and processes designed specifically to meet these challenging requirements.
Our Pharmacokinetic Services team conducts typical pharmacokinetic study which involves administering a fixed amount of the drug (the dose) to the subject (various animals) and at various times post dose, samples of an easily accessible tissue (usually blood/plasma) are drawn and collected for analysis of the drug
From standard screening to more complex PK studies, our team of experienced study directors can also assist in designing the best strategy and protocols customized to suit any drug discovery program.
In Vivo PK Studies
- Rank-ordering compounds/formulations
- Bioavailability and bioequivalence
- Dose proportionality (ascending dose)
- Dose linearity (multiple dose)
- Drug-drug interactions
- Special populations
- Tissue distribution (non-radioactive and radioactive)
- Blood brain barrier
- Anti-drug antibodies
- Non-compartmental and compartmental pharmacokinetics
- Pharmacodynamic and pharmacokinetic/pharmacodynamics modeling
- Input into study design, including preclinical-to-clinical considerations (allometric scaling and human equivalent dose projections)
Administration Routes and Collection
- Single agents, cassette dosing, single dose and repeat dose
- Dosing by PO, IV, IP, SC, etc.
- Serial sampling in all species
- Tissue, urine and CSF collection
- Bile collections by bile duct cannulation (BDC)
- Fully integrated bioanalysis services
- Bile duct cannulation
- Vascular access ports
- Portal vein cannulation
- Intestinal access ports
Pharmacokinetic Studies and Services will include:
- Evaluating compounds in various formulations, both solution as well as suspension dosing in various species.
- Studying correlative aspects between the in vitro and in vivo metabolism of analogs to increase throughput and help lower cost.
- Dose escalation studies in rats or dogs with the potential for follow up in the 7- and 28-day tox studies in rats/dogs that would help plan for Phase I and in some cases Phase II clinical trials.
- Cassette (n-in-1) PK for early discovery compound screening and decision prioritization
- Drug distribution in tissue/organ and body fluid and determination of blood and brain ratio for brain penetration
- Metabolic kinetics with active metabolites
In order to provide a significant enhancement in speed and efficiency it becomes highly beneficial at GVK BIO to conduct both the in vivo PK quantification and identification of the major metabolites on a single instrument platform. provides our customers fast turnaround and close management of PK screening projects.
That was the comprehensive list of our Pharmacokinetic Services. Feel free to contact us regarding any query. Our PK Services team will get in touch with you as soon as possible.