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PK studies

Pharmacokinetic (PK) studies are an essential part of preclinical research. They provide information on how a drug is absorbed, distributed, metabolized, and excreted in the body. This information is critical for understanding the safety and efficacy of a drug, and for designing clinical trials.

Here are some of the key benefits of PK studies in preclinical research:

  • Identify safety risks. PK studies can help to identify potential safety risks associated with a drug, such as toxicity or drug-drug interactions. This information can be used to inform the design of clinical trials and to mitigate safety risks.
  • Determine optimal dosing. PK studies can help to determine the optimal dosing regimen for a drug, including the dose level, frequency of administration, and route of administration. This information is essential for ensuring that patients receive the correct dose of the drug to achieve the desired therapeutic effect.
  • Predict human PK. PK studies in animals can be used to predict how a drug will behave in humans. This information can be used to design clinical trials and to interpret clinical data.
Biotrial-preclinical-Pk-Analysis

Overall, PK studies play a vital role in preclinical research. They provide essential information on the safety, efficacy, and dosing of new drugs. This information is critical for the successful development of new drugs and for bringing them to market safely and effectively.

Biotrials PK Experience

Our team of highly experienced pharmacokineticists can design and conduct PK studies to meet your specific needs in developing and bringing new drugs to market safely and effectively.

We offer a wide range of PK services, including:

  • Non-compartmental analysis (NCA): This is the most common type of PK analysis and is used to estimate basic PK parameters, such as AUC, Cmax, and Tmax.
  • Compartmental analysis (CA): This type of PK analysis is used to model the distribution and elimination of drugs in the body using mathematical compartments. CA can be used to understand the mechanism of drug action and to predict PK profiles under different dosing conditions.
  • Pharmacokinetic-Pharmacodynamic (PK-PD) analysis: This type of analysis is used to relate drug concentrations to drug effects. PK-PD analysis can be used to optimize dosing regimens and to identify potential safety risks.
  • Population pharmacokinetics: This type of PK analysis is used to model the PK of drugs in a population of patients. Population pharmacokinetics can be used to identify factors that influence drug PK and to develop dosing regimens for specific patient populations.
Biotrial-preclinical-Analysis
Biotrial-preclinical-Analysis

In Vivo Pharmacokinetics

Biotrial is a global leader in vivo pharmacokinetics and tissue distribution research services. We have extensive experience conducting in vivo pharmacokinetics studies in rodents and non-rodents. We offer a variety of in vivo pharmacokinetic services, including:

  • Method of administration: Intravascular/Subcutaneous/Intramuscular/Intraperitoneal/Per Os, etc.
  • Biological samples: Plasma, whole blood, Cerebro Spinal Fluid (CSF), bile, and other fluid biological matrices.
  • Organs: Distribution experiment and Blood Brain Barrier (BBB) transmission experiment of the brain, Cerebro-Spinal Fluid, liver, heart, kidney, etc.
  • Excretion: Feces, urine, bile, etc.

We work closely with our clients to design and execute the most appropriate in vivo pharmacokinetic studies for their specific needs. Our goal is to help our clients develop safe and effective new drugs by supporting them throughout the drug discovery and development process.

We also offer a variety of other services, such as:

  • Study design and protocol development
  • Data analysis and interpretation
  • Report writing
  • Regulatory support

We are committed to providing high-quality, comprehensive, and timely PK services to our sponsors. Our goal is to help sponsors develop safe and effective new drugs by supporting them throughout the drug discovery and development process.

State-of-the-art preclinical facility

Our preclinical facility is AAALAC-accredited, which means that it meets the highest standards of animal welfare and scientific rigor. We have a variety of equipment and facilities to support our PK studies, including:

  • Bioanalytical laboratory
  • Pharmacology laboratory
  • Animal housing facility
  • Data analysis and reporting software

We are constantly investing in new technologies and equipment to ensure that we are offering the most advanced PK services available.

Biotrial-clinical-pharmacy

Supporting activities

  • Advice on synopsis, protocol writing, and statistical analysis plan
  • Interim analysis for preclinical studies
  • Interim analysis for clinical studies (ex: SAD/MAD study, IH/IR)
  • Sample size estimations (BE, DDI studies)
  • Production of TFLs (Tables, Figures, Listings)
  • Writing of PK section for CSR (ICH format) or a dedicated PK report

Resources

Pharmacokinetics and telemetry in minipigs
Evaluation of the sensitivity of the qt assay
IMPROVEMENT OF ANIMAL WELFARE IN A MODEL OF COMBINED PHARMACOKINETICS AND TELEMETRY IN THE MINIPIG : HOW CAN REFINEMENT AND STUDY DESIGN REDUCE THE ANIMAL’S STRESS ?

The minipig is a large species used in pharmacokinetics and cardiovascular models, as it has physiology and cellular receptors similarities with humans.

  • Defining and refining study design to limit the possible impact of stress on study data
  • Technical improvement Welfare improvement VS The minipig is highly sensitive to stress
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A JOINED INITIATIVE TO EVALUATE SENSITIVITY OF THE QT ASSAY WITH THE ICH E14/S7B Q&A BEST PRACTICE RECOMMENDATIONS

In the context of the ongoing ICH E14/S7B Q&A process, it is critical to demonstrate the sensitivity of the in vivo QT assay to detect small QTc prolongation (i.e. ≤10 msec) of investigational drugs and conduct a concentration-QTc analysis to complement the standard “by time point” analysis approach and to mimick the clinical approaches. A collaborative cardiovascular study was designed in telemetered dogs using six QT-positive and one QT-negative reference drugs previously evaluated in healthy volunteers in the QT study conducted by Darpo et al. in 2015. As in the Darpo’s trial, tested doses were chosen in order to reach exposure level inducing an increase of at least 10ms of the QTc interval. The results obtained with four drugs, dolasetron, moxifloxacin, dofetilide and levocetirizine, are presented here. Data for the other drugs are still being analysed.

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