Pharmacokinetics and safety profiling are essential components of drug development, providing critical data on the absorption, distribution, metabolism, excretion (ADME) properties, and safety of pharmaceutical compounds. These analyses help identify optimal drug candidates, predict potential adverse effects, and determine safe dosing levels. At BOC Sciences, we employ state-of-the-art technologies and extensive research expertise to deliver comprehensive pharmacokinetics and safety profiling services. Our robust platforms and validated models ensure accurate, reliable, and reproducible results, supporting drug discovery and development across a wide range of therapeutic areas. By integrating innovation and stringent quality control, BOC Sciences continues to be a reliable partner in advancing the development of safe and effective treatments.
While pharmacokinetics and safety profiling stand as essential steps in drug development researchers encounter multiple difficulties during this stage. The issue of individual variability arises because differences in how people absorb, metabolize, and excrete drugs create inconsistent data and increase complexity. Different experimental conditions can produce varying results from pharmacokinetic studies due to multiple parameters like half-life and plasma drug concentrations which complicate data analysis. Extended monitoring necessary for safety profiling requires precise experimental designs to determine how compounds affect organs and systems throughout time. The growth in drug candidate numbers creates substantial difficulty in performing high-throughput screening to effectively conduct both pharmacokinetic and safety evaluations of various compounds. The differences between in vitro test results and in vivo responses make it hard to confirm the relevance of experimental findings. The prediction of long-term toxicity continues to pose difficulties since safety profiling needs to detect immediate toxic effects and anticipate possible long-term adverse outcomes through precise and thorough experimental techniques.
Leverage cutting-edge technologies for efficient pharmacokinetics and safety profiling, ensuring accurate and reproducible results across multiple drug candidates.
A dedicated team of pharmacology and toxicology experts ensures professional experimental design, robust data analysis, and comprehensive insights.
Offer a variety of reliable animal models to simulate real biological responses, enhancing the accuracy of pharmacokinetic and safety assessments.
Utilize advanced statistical and bioinformatics tools to interpret complex data, ensuring high precision and reliability in the findings.
Implement stringent quality control measures throughout the testing process, ensuring reproducibility and accuracy in all experimental results.
Provide pharmacokinetics and safety profiling services for a broad range of drug types, including small molecules, biologics, and large molecule therapeutics.
BOC Sciences delivers comprehensive pharmacokinetics testing services that help advance your drug discovery and development initiatives. Our testing methods provide important information about a drug's ADME properties. These tests represent some important services we provide.
Our laboratory performs experiments to measure how much time is needed for a drug's blood concentration to decrease by fifty percent. Testing shows how long drugs maintain effectiveness in the body and helps determine the correct dosing schedule.
Through plasma concentration tracking over time we observe a drug's distribution across the body. Medical professionals need this analysis to understand the drug's metabolic process and its distribution sites within the body.
The volume of distribution test measures how widely a drug distributes across body tissues relative to its plasma concentration. The evaluation examines how effectively a drug reaches its target tissues and organs.
Clearance testing assesses the rate at which a compound is eliminated from the body, providing critical insights into drug elimination kinetics. This parameter supports the development of appropriate dosing strategies by informing decisions related to exposure levels, duration of action, and compound optimization for safety and performance.
The excretion tests we perform analyze the removal process of drugs and their metabolites through renal and biliary pathways. The study of drug elimination is essential for understanding how the drug behaves over extended periods and affects elimination organs.
The measurement of the highest plasma drug concentration following administration defines Cmax. The potency assessment of this test determines the best dosing intervals for the drug.
Our Tmax (time to maximum concentration) test measures the time it takes for a drug to reach its maximum concentration in the bloodstream. It is a key factor in understanding the rate of drug absorption and its onset of action.
We calculate the AUC (area under the curve), which represents the total drug exposure over time. This essential measure helps assess bioavailability and provides an overall understanding of the drug's pharmacokinetic profile.
At BOC Sciences, we offer a broad range of safety profiling tests to support your drug discovery and development efforts. Our services are designed to assess the toxicity, safety, and potential risks of pharmaceutical compounds. Below are some of the key safety tests we provide:
Our acute toxicity test evaluates the toxic effects of a single dose of a drug, determining its lethal dose and the immediate toxic effects on the organism.
The subacute and subchronic toxicity tests assess the potential health effects of repeated drug administration over a prolonged period, identifying any cumulative toxic effects.
This test involves long-term drug exposure to evaluate the potential effects of prolonged use on organs and bodily systems, identifying any long-term health risks.
Our genotoxicity test assesses whether a drug induces DNA damage, leading to gene mutations, chromosomal abnormalities, or cancer, providing insights into its genetic safety.
This test evaluates the potential impact of drugs on reproductive health, including effects on fertility, embryonic development, and fetal health.
Our immunotoxicity test examines the impact of drugs on the immune system, checking for potential suppression or overstimulation of immune responses.
Through this analysis, we assess the metabolites of a drug to determine if any toxic compounds are formed during metabolism, helping to predict any adverse effects.
The cardiovascular toxicity test examines the effects of a drug on the heart and blood vessels, detecting potential arrhythmias, blood pressure changes, or other cardiovascular risks.
Our hepatotoxicity test evaluates the potential for drug-induced liver damage, including liver function impairment, fatty liver, or other hepatic disorders.
The nephrotoxicity test assesses the drug's potential to cause kidney damage or dysfunction, helping to ensure renal safety during drug development.
We offer neurotoxicity testing to evaluate the effects of drugs on the nervous system, including potential nerve damage, cognitive impairment, and other neurological effects.
Our acute dermal toxicity test evaluates the effects of drugs absorbed through the skin, determining any immediate toxic responses or irritations caused by dermal exposure.
We offer reliable in vitro and in vivo models to support researchers in pharmacokinetics and safety profiling studies. Our models are specifically designed to simulate drug absorption, distribution, metabolism, excretion, and toxicity with high accuracy, enabling comprehensive evaluation of drug candidates. Utilizing advanced testing platforms, we assist researchers in assessing compound behavior and identifying potential safety risks, delivering critical data to guide compound optimization and streamline development workflows. We support, but are not limited to, the following platforms to deliver these testing services:
| Cell Culture Models | Blood-Brain Barrier Models |
| Tissue Culture Models | Enzyme Inhibition Assays |
| Organoid Models | Permeability Assays |
| Non-human Primate Models | Preclinical PK Studies |
| Canine and Rabbit Models | Toxicological Models |
| Transgenic Animal Models | Behavioral Models |
We offer a range of advanced testing and analytical instruments to support pharmacokinetics and safety profiling studies. These instruments are designed to help researchers assess drug behavior and safety, ensuring reliable results to inform drug development decisions and enhance the efficiency of research processes.
| HPLC | Dialysis System |
| MS | Blood-Brain Barrier Model System |
| LC-MS | Cell Culture Incubator |
| Liquid Scintillation Counter | Fluorescence Spectrophotometer |
| Cell Counter | Animal Monitoring Systems |
Project Scoping & Requirement Clarification
Engage in in-depth communication with the client to clarify the background of the project, the physicochemical properties of the drug candidates, target indications, and the specific pharmacokinetic or toxicological data requirements. This ensures the workflow is fully aligned with the client's research priorities.
Customized Protocol Development
Develop a tailored experimental strategy based on the research objectives. This includes selecting appropriate PK modeling methods, ADME profiling assays, and toxicity evaluation approaches, as well as defining dose ranges, study endpoints, and relevant controls.
Preclinical System Setup
Establish and validate in vitro systems (e.g., liver microsomes, efflux transporter assays) or in vivo models (e.g., rodent pharmacokinetic studies), equipped with standardized analytical platforms such as LC-MS/MS, plasma protein binding assays, and Caco-2 permeability tests.
Execution of PK/Tox Studies
Conduct comprehensive pharmacokinetic and toxicological studies, including blood concentration–time curve analysis, bioavailability assessment, dose dependency studies, and acute or sub-chronic toxicity evaluations under GLP or research-grade conditions.
Quantitative Data Analysis & Interpretation
Collect and statistically analyze experimental data, perform compartmental or non-compartmental modeling, calculate key PK parameters (e.g., AUC, Cmax, T1/2, CL), and integrate toxicity findings. Deliver visualized data outputs and mechanistic insights to support scientific interpretation.
Reporting & Scientific Recommendations
Deliver a detailed scientific report including experimental protocols, pharmacokinetic profiles, toxicological observations, graphical summaries, and actionable recommendations to guide further development or regulatory strategy.
Providing PK and safety profiling testing for cancer therapeutics, evaluating the ADME characteristics and potential toxicity of drugs, supporting the drug development process for oncology treatments.
Offering PK and safety testing for drugs targeting neurodegenerative diseases (such as Alzheimer's and Parkinson's), analyzing the drug's metabolic pathways in the central nervous system and its potential neurotoxic effects.
Specializing in pharmacokinetics and safety assessment of cardiovascular drugs, testing their effects on the heart and vascular system, including blood pressure changes and arrhythmias.
Providing PK and safety testing for drugs targeting diabetes and other metabolic disorders, evaluating the drug's metabolism and its impact on metabolic systems.
Assessing drugs for autoimmune diseases (such as rheumatoid arthritis and systemic lupus erythematosus) with a focus on immune system effects and potential immunotoxicity.
Offering PK and safety testing for antibiotics and antiviral drugs, analyzing the drug's effect on pathogens and its potential toxic effects, supporting the development of infection-fighting therapeutics.
Providing pharmacokinetics and safety assessment for pain management drugs (such as analgesics and anesthetics), ensuring the drug effectively alleviates pain without causing harm to the patient's physiological systems.
Evaluating pharmacokinetics and safety of gene therapies and biologics (such as vaccines and monoclonal antibodies), analyzing cellular absorption, gene transfer efficacy, and potential immune reactions.
What are pharmacokinetics testing services?
Pharmacokinetic testing can evaluate key parameters of drugs such as bioavailability, exposure level, half-life and clearance rate, thereby providing a scientific basis for the development of new drugs.
Why is safety profiling crucial in drug development?
Safety profiling identifies potential risks, such as toxicity and adverse effects, during drug development. It involves testing for organ toxicity and long-term safety, ensuring the drug's overall suitability and minimizing harmful side effects.
What models are used in PK and safety testing?
PK and safety testing use both in vitro and in vivo models, including cell cultures, animal models, and disease-specific systems. These models replicate how drugs behave in the human body, providing accurate insights into drug performance and risks.
How does BOC Sciences ensure precise PK and safety testing?
BOC Sciences utilizes cutting-edge testing platforms, advanced equipment, and well-established models to provide accurate PK and safety data. Our tailored services ensure that drug candidates are tested for optimal performance and safety.
Can BOC Sciences offer customized PK and safety testing services?
Yes, BOC Sciences provides customized PK and safety testing solutions based on the specific needs of drug candidates. We design testing protocols to match your unique research objectives, ensuring accurate and reliable results.
