Pharmacokinetic/Pharmacodynamic (PK/PD) is a scientific technique used in drug development to establish a relationship between the drug dose, the subsequent pharmacokinetics or drug concentration-time profile in systemic circulation, and the observed drug effects or pharmacodynamic observation. This technique is an integral part of translational medicine and clinical pharmacology that aims to predict a drug's behavior in the human body and how it can impact the human body. The PK aspect refers to the absorption, distribution, metabolism, and excretion (ADME) of a drug, detailing how the body affects a drug's concentration over time. Meanwhile, PD broadly addresses how the drug influences biological pathways in the body leading to therapeutic or adverse effects. Understanding PK/PD is crucial in determining dosage, frequency, and duration of a drug regimen that would maximize therapeutic effects while minimizing any side effects. Our company is a leading provider of PK/PD services, with many years of experience in the industry. We use our scientific expertise to provide integrated PK/PD analytical services, which ensure effective drug development strategies and superior clinical outcomes.
Our PK/PD Services
At our company, based on ICH guidelines, we provide PK/PD research services from preclinical to clinical by using industry standard software (Phoenix WinNonlin). We leverage robust PK/PD modeling and simulations to craft custom anti-infective, immunological, oncology, and many other small molecule drugs or macromolecular drugs development strategies. Our team of experts can generate mathematical models to predict concentration time-course profiles in systemic and target-site compartments as well as effect-response curves.
Our PK/PD services include but are not limited to the following:
- PK/PD study design.
- PK/PD modeling and simulation (including population approach, disease-based modeling and PBPK).
- PK/PD data analysis and reporting of PK and PD outcomes.
- PK/PD data interpretation.
- Linear or non-linear pharmacokinetics mixed modeling techniques.
- Non-compartmental and compartmental PK analysis.
- All of statistical analyses such as bioavailability, bioequivalence, dose proportionality, drug interaction studies, special populations and others.
Clients benefit from our PK/PD services in the following areas:
- In pre-clinical phases, the PK/PD service can be used to select multiple candidate compounds, predict the clinical efficacy value EC50, provide guidance for the dose range and sampling protocol setting of early clinical trials, evaluate the safety margin of compounds according to the target efficacy concentration, and conduct potential DDI risk assessment.
- During the clinical stage (for Phase 3 study), PK/PD service can be used primarily to validate optimized population PK/PD models, build or validate dose-exposure-response associations in target populations, and evaluate dose-adjustment regiments for specific populations.
Our Advantages
Our PK/PD service is characterized by its attention to reliability, experience, accuracy and compliance.
Reliability: We have a highly skilled multi-disciplinary team with extensive knowledge and expertise in PK/PD analysis.
Experience: At our company, top-notch PK/PD services from industry professionals with many years of experience to meet your requirements.
Accuracy: We employ advanced analysis and modeling techniques, ensuring accurate and reliable results.
Compliance: Plus, our thorough understanding of regulatory requirements guarantees your studies will meet global drug-approval standards.
These strengths, combined with advanced techniques, position us as an industry leader in PK/PD analysis services.
WE ARE
PROFESSIONAL
Our company, therefore, stands out in the pharmaceutical industry not just for our scientific acumen, but for our commitment to delivering superior PK/PD analysis to drive clients' drug development projects. By choosing us, you choose unparalleled scientific expertise and a dedication to excellence that can facilitate your journey from drug conception to clinical application. If you are interested in our services or have any questions or needs, please feel free to contact us. We will be happy to provide you with support and services.
Related Services
It should be noted that our service is only used for research, not for clinical use.
