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Project Description

Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Drug Safety Evaluation Services

Drug safety evaluation begins with in vitro studies, which examine the drug's interaction with biological systems at the cellular and molecular level. This is followed by in vivo studies using animal models to assess the potential toxicity of the drug. At Protheragen, we are committed to delivering exceptional drug safety evaluation services that meet the unique needs of rare cancer drug development.

Introduction to Drug Safety Evaluation

Drug safety evaluation is a critical component of the pharmaceutical development process, ensuring that medications are safe for human use before they reach the market. This scientific discipline involves a series of assessments to determine the safety profile of a drug, which includes understanding its potential adverse effects and establishing a safe dosage range. The evaluation encompasses a broad spectrum of studies, from in vitro tests to in vivo animal models, and eventually to clinical trials in human subjects.

Contrasts between past and present patient-derived cancer models.

Fig.1 Use of in vitro assays for kidney toxicity de-risking including cell type used. (Troth S. P, et al., 2019)

Drug Safety Evaluation in Rare Cancer

Rare cancer drugs often target novel molecular pathways or employ innovative delivery mechanisms, which necessitates a comprehensive assessment of their safety profile. Thorough preclinical studies, including general toxicology, genetic toxicology, and specialized evaluations (e.g., immunotoxicity, reproductive toxicity), are essential to identify potential adverse effects and establish safe dosing regimens.

By diligently evaluating the safety of rare cancer drug candidates, researchers can optimize their development, mitigate risks, and ultimately improve the likelihood of successful clinical trials and regulatory approvals. This step-by-step approach strengthens the integrity and credibility of the drug development process, promoting trust and confidence in the medical community and the public.

Our Services

To support the development of safe and effective rare cancer therapies, our company offers a comprehensive suite of drug safety evaluation services tailored to the unique needs of this field. Our state-of-the-art facilities and experienced scientific team collaborate closely with clients to design and execute specialized studies that address the challenges inherent to rare cancer drug development.

General Toxicology Assessments

We conduct a range of single-dose and repeat-dose toxicology studies across various animal species to thoroughly evaluate the systemic toxicity of rare cancer drug candidates. These studies assess the impact on major organ systems, including the cardiovascular, respiratory, and central nervous systems, providing crucial insights into a compound's safety profile.

Genetic Toxicology Evaluations

Recognizing the importance of assessing the genotoxic potential of rare cancer drugs, our team performs a battery of in vitro and in vivo assays to detect DNA damage, chromosomal aberrations, and mutagenicity. These studies help ensure the genetic safety of drug candidates and support their progression towards clinical trials.

Specialized Toxicology Assessments

Beyond the standard toxicology evaluations, our company offers a range of specialized studies tailored to the unique needs of rare cancer drug development. This includes assessments of immunotoxicity, reproductive and developmental toxicity, and ocular toxicity, among others. These targeted evaluations help to identify potential safety liabilities and guide the optimization of rare cancer therapeutics.

Toxicokinetic Analyses

Understanding the absorption, distribution, metabolism, and excretion (ADME) properties of rare cancer drugs is crucial for establishing safe dosing regimens and predicting potential toxicities. Our team conducts in-depth pharmacokinetic and toxicokinetic studies, leveraging advanced analytical techniques to provide comprehensive data on the fate of these compounds in the body.

Our team of seasoned scientists, toxicologists, and pharmacokineticists possess deep expertise in the field of rare cancer research. They stay abreast of the latest scientific advancements and regulatory guidelines, enabling them to provide tailored solutions that address the complex challenges faced by our clients. If you are interested in our services, please feel free to contact us for more details and quotation information of related services.

Reference

Troth, Sean P., et al. "Kidney safety assessment: current practices in drug development." Seminars in nephrology. Vol. 39. No. 2. WB Saunders, 2019.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.