An ISO9001 Certified Supplier of Pre-Clinical Contract Research Service and Analytical Service
Understanding how drugs move through the body is critical to ensuring their safety and efficacy. At Protheragen-ING Lab, we offer comprehensive pharmacokinetic (PK) services to meet the specific needs of pharmaceutical companies, contract research organizations (CROs), and academic institutions. Our state-of-the-art facilities and experienced team ensure that results are accurate and reliable, helping our clients move forward with their drug development programs with confidence.
Importance of pharmacokinetic studies
PK studies provide an in-depth look at how drug compounds are absorbed, distributed, metabolized, and excreted (ADME) by the body over time. Understanding a drug's bioavailability, exposure, half-life, clearance and metabolism may be the difference between clinical success and failure.
By studying the PK of drugs, researchers can gain valuable insights into their behavior, optimize dosing regimens, assess drug-drug interactions, and ensure drug safety and efficacy.
Pharmacokinetic capabilities of the Protheragen-ING Lab
- PK Study Design: Our experts collaborate closely with clients to design customized PK study protocols tailored to their specific drug candidates and research goals. We take into account factors such as route of administration, dosing regimen, sampling schedule, and analytical methods to ensure accurate and meaningful data generation.
- PK Sampling and Analysis: We employ advanced techniques for blood, plasma, and tissue sample collection at predefined time points to capture crucial PK data. Our team utilizes cutting-edge analytical methodologies, such as liquid chromatography-mass spectrometry (LC-MS) and high-performance liquid chromatography (HPLC), to quantify drug concentrations accurately and assess various PK parameters.
- PK Data Analysis and Interpretation: Our skilled scientists utilize sophisticated software and modeling techniques to analyze the obtained PK data. We calculate key parameters such as area under the concentration-time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), and half-life (t1/2). Our comprehensive analysis provides valuable insights into drug absorption, distribution, metabolism, and excretion.
Our pharmacokinetic service options
Protheragen-ING Lab's PK study services include but are not limited to:
| Dose optimization studies | Determine the optimal dosing regimen for a compound by evaluating the PK profile of the compound at different doses. |
| Bioavailability and bioequivalence studies | Determine the optimal dosing regimen for a compound by evaluating the PK profile of the compound at different doses. |
| Drug interaction studies | Investigate the potential for interactions between drugs or between drugs and foods, beverages, or other physiologically active substances. |
| Metabolite profiling | Identifying and characterizing the metabolites produced by drug metabolism, which is critical to understanding drug efficacy and safety. |
| Tissue distribution studies | Examine the distribution of a drug in different tissues and organs to assess its targeting and potential side effects. |
| PK/Pharmacodynamic (PK/PD) modeling | Use mathematical models to predict drug behavior and optimize drug delivery based on PK and pharmacodynamic data. |
Our in vivo pharmacokinetic study methods
- Route of administration: Choose the appropriate route of administration according to the study purpose and drug properties, common routes include oral, intravenous, subcutaneous, intramuscular, etc.
- Labeled drug: Track the dynamic process of the drug in vivo through labeled drugs, such as radioisotopes, stable isotopes, fluorescent dyes, and so on.
- Sample collection: According to the research needs, samples of blood, urine, saliva, etc. are collected within a certain period of time after the administration of drugs in order to obtain the concentration-time data of drugs in the body.
- Drug Concentration Determination: Various analytical techniques, such as HPLC, MS, RIA, etc., are used to determine the concentration of the drug in the sample.
- Data analysis: Through the drug concentration-time data, mathematical models are applied to calculate and analyze PK parameters, such as the elimination half-life of the drug, the volume of distribution of the drug, and the clearance rate.
- PK model: Based on experimental data and theoretical knowledge, a PK model is established to predict the drug concentration of the drug in the body as well as the optimization of the dosing regimen.
- Individual difference study: Considering the differences between individuals, such as gender, age, weight, etc., the analysis of individual differences is carried out in order to determine the individualized drug administration scheme.
- Relevant parameter studies: Through PK studies, relevant parameters of the drug can also be obtained, such as the bioavailability of the drug, the protein binding rate of the drug, and the metabolic rate of the drug.
Protheragen-ING Lab adheres to Good Laboratory Practice (GLP) standards and prioritizes regulatory compliance at every stage of PK studies. We are your trusted PK research partner, enabling you to tackle the complexities of drug development with confidence and efficiency.
For more information about our pharmacokinetic services or to discuss your specific needs, contact us today.