Pharmacokinetic (PK) and pharmacodynamic (PD) studies are critical for evaluating and optimizing new drug candidates in early drug discovery and development stages. Conducting PK studies before engaging in costly efficacy trials ensures that drug formulations and dosages provide adequate exposure in test animals and significantly reduce the risk of failure in later stages of drug development. PK/PD studies range from exploratory analyses to those demanding GLP compliance.
High-quality data are essential for classifying lead candidates, assessing bioavailability, or studying tissue distribution. With specialized expertise and a broad range of animal models, our team delivers critical PK/PD insights to advance your drug development program.
In-Depth In Vivo PK Studies
PK studies influence species selection, study design, and guide dosing schedules. Our studies range from short-term single-dose studies of a few hours to long-term repeated dose or depot formulations of up to six months or longer. We meticulously evaluate key PK parameters to understand a drug’s behavior within the body thoroughly:
- Area Under the Curve (AUC): Tracks overall drug exposure over time.
- Clearance: Measures the rate at which the drug is removed from the bloodstream.
- Tissue Distribution: Analyzes how the drug spreads through different body tissues.
- Half-Life: Indicates the time the drug’s plasma concentration halves.
- Maximum Concentration (Cmax): Identifies the peak blood concentration post-dosing.
- Minimum Concentration (Cmin): Determines the lowest concentration during a dosing interval.
These metrics collectively assist in refining dosing protocols and enhancing the therapeutic and safety profiles of the drug.
Advancing Drug Development With In Vivo PD Studies
Building on robust PK insights, our in vivo PD studies further explore the biological effects of drugs on specific targets within the body. We conduct precise assessments of biochemical markers, including hormones and cytokines, enabling you to:
- Monitor the drug’s impact on the body’s stress response, exemplified by our 24-hour stress-free cortisol measurement in minipigs. This model is particularly relevant for developing treatments for neurodegenerative diseases and stress-related conditions.
- Evaluate how vaccines and immunomodulatory drugs affect immune and inflammatory responses.
We can conduct additional drug-specific PD evaluations tailored to each study’s requirements. Such detailed evaluations are crucial for defining a drug’s pharmacodynamic profile, which helps optimize therapeutic strategies.
Animal models, Administration Routes, and Sample Collection
The choice of the right animal model is crucial for the success of PK/PD studies. We employ a range of rodent and non-rodent animal models, with a special focus on the minipig due to its significant similarities to human anatomy and physiology, particularly skin, heart, and gastrointestinal tract development. We offer a variety of administration routes and ensure precise drug delivery and data collection for each study. Our advanced sampling protocols, like microsampling, are crucial for generating reliable time-course data for accurate PK/PD analyses.
PK/PD Support Services
For clients lacking specific in-house capabilities, we offer extensive support in bioanalysis and drug formulation:
- Bioanalysis: Our scientific experts use cutting-edge technologies like LC-MS, ELISA, qPCR, and Immunohistochemistry to provide rapid and sensitive determinations of drug concentrations across various biological matrices.
- Drug formulation: Our scientists can pre-formulate your drug substance to ensure drugability. We develop drug formulations for all types of products and perform technical batch manufacture for preclinical testing.
Why Choose Scantox
- Experience: We have extensive experience with small chemical compounds, peptides, proteins, antibodies, nanoparticles, vaccines, and even implants and sustained-release depots.
- Customized Approach: We tailor each study and protocol to meet each client’s needs, from standard screening to more complex studies.
- Optimized Processes: Our laboratories, protocols, and processes are specifically designed to meet the rigorous demands of PK studies.
FAQs
Pharmacodynamics explores how drugs affect the body and produce responses. Pharmacokinetics examines how the body processes drugs, including absorption, distribution, metabolism, and elimination. Our PK/PD service integrates both aspects, providing detailed data on a drug’s movement and interaction within the body.