In Vivo PK Studies of Radiopharmaceuticals
At Rdcthera, we specialize in contract research organization services that cater to the special requirements for the development of radiopharmaceuticals. Having deep roots in various fields of radiopharmaceutical research, we enable delivery of full and reliable PK data underpinning radiopharmaceutical development and regulatory approval for efficacy and safety.
In Vivo PK Studies
In vivo pharmacokinetic (PK) studies are a key part of the drug propulsion process and are essential for understanding the behaviour of radiopharmaceuticals in living organisms. These studies provide an important basis for understanding the absorption, distribution, metabolism and excretion (ADME) of radiopharmaceuticals, helping to optimise their therapeutic potential and manage dosing regimens to expand adequacy and avoid unwanted effects. Conducting PK studies also allows the determination of PK parameters such as AUC, clearance, half-life, volume of distribution, Cmax, and Cmin.
Fig.1. Pharmacokinetic Properties of Peptidic Radiopharmaceuticals. (Eder M, et al., 2013)
Our Extensive PK Assessment Services
State-of-the-art, customized PK assessment services as required in radiopharmaceutical development. Our capabilities include:
Precise quantification of radiopharmaceutical concentrations in biological matrices through sophisticated techniques such as LC-MS and PET imaging.
Detailed profiling of absorption, distribution, metabolism, and excretion.
- Bioavailability and Bioequivalence Studies
Studies for comparison of the pharmacokinetic profiles of different formulations or various dosages.
- Pharmacodynamic (PD) Correlation
Integration of PK data with pharmacodynamic outcomes to understand the therapeutic effects of the drug.
Multi-Species In Vivo PK Studies
Rdcthera performs in vivo PK studies in a range of species, going from rodents to rabbits and non-human primates. This spread will help to ensure that the data we generate for our clients are robust and translatable to human studies. Species models are selected with consideration for specific requirements pertaining to the radiopharmaceutical being studied: It gives us valuable insights into its overall pharmacokinetic profile.
Administration Routes
Our PK studies encompass various administration routes, including
- Intravenous
- Intramuscular
- Sublingual
- Intravitreal
- Subcutaneous
- Intraperitoneal
- Nasal
- Oral
- Transdermal
- Cassette Administration
- Intrathecal drug delivery
- Continuous Microblood Collection
Why Choose Rdcthera?
Rdcthera has developed a practice in handling various PK study designs. Our objective is to provide fast turnarounds with quality results at a reasonable cost. In combination with the results from in vitro ADME screening, in vivo PK information allows for the very early identification of compound negatives.
Partner with Rdcthera to access our enormous volume of experience in in vivo PK studies with radiopharmaceuticals. Contact us today to discuss your project needs and learn how we at Rdcthera can help you on your journey of drug development.
Reference
- Eder M, Löhr T, Bauder-Wüst U, et al. (2013). Pharmacokinetic properties of peptidic radiopharmaceuticals: reduced uptake of (EH)3-conjugates in important organs. J Nucl Med. 54(8):1327-1330.
For research use only. Not intended for any clinical use.
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