Pharmacokinetic Studies (PK)
Pharmacokinetic studies are critical in drug development, and a key component of PK PD studies, helping in determining the appropriate dosage, optimizing drug formulations, and assessing the safety and efficacy of drugs. Pharmacokinetic studies concentrate on understanding how the body interacts with substances that are administered, through examining the movement of these substances throughout the body, including their absorption, distribution, metabolism, and elimination (ADME).
PK studies can be utilized in order to make informed decisions, conduct risk assessment, and contribute to successful drug development.
Determining Dosage: Using ADME studies, the appropriate dosage for therapeutic effects can be discovered that minimal side effects.
Formulation optimization: Knowledge of drug pharmacokinetics helps in designing formulations, enhancing delivery, efficacy, and stability.
Safety Assessment: Evaluating how the body processes and eliminates administered substances, enables identification of any potential toxicities, interactions of the drugs, and safety concerns during the course of development.
Efficacy Evaluation: Drug concentration and duration of action in the target tissues is assessed through PK PD studies, refining drug design, and the therapeutic potential of the substance.
Regulatory Compliance: Pharmacokinetic profiles guide regulatory submissions, demonstrates safety, efficacy, and presents the appropriate dosing recommendations to gain approvals.
Pharmacodynamic Studies (PD)
Pharmacodynamic studies determine how drugs and substances exert their effects on biological systems within living organisms, providing an understanding on how the drug modulates target receptors, enzymes, and cellular pathways, analyzing the biographical processes it undergoes. In Vivo PD studies will provide an insight into the mechanism of action, potency, and efficacy of the drug, alongside a wide range of additional support for drug development including:
Dose-response relationship: The effects of a substance at varying doses is analyzed against the desired pharmacological response, evaluating the optimal dose range, in turn determining if the drug achieves the required therapeutic outcome.
Effective dosage range: PK PD studies will aid in identifying the therapeutic range of the drug or substance, contributing to the optimization of dosing regiments, and lowering the risk of adverse effects.
Identifying Biomarkers: Specific biomarkers will be identified, indicating the efficacy and safety of the substance, these biomarkers can be used to monitor responses during clinical trials, streamline the development of drugs, and personalize treatment approaches.
Interactions between substances: The pharmacodynamic interactions between the target drug and other substances can be assessed, allowing the development of drug combination strategies, along with predicting potential adverse effects, and optimizing therapeutic regimens.
Predictive modelling: Development of predictive models that will simulate the drug’s effect in different scenarios, helping forecast drug responses, optimizing dosing strategies, and informing decisions throughout the development process and clinical trial design.
We offer in-house tissue and blood collection, data compiling, and analysis with a quick turnaround in order to support your PK PD studies.
We support our customers throughout all phases of development, and offer a diverse selection of services, including PK PD studies, to help them reach their goals.
- Excretion or elimination
- Elimination half-life
- Hill coefficient