QPS

QPS stands forA global CRO providing comprehensive support ranging from pharmacology, DMPK, and toxicology to bioanalysisSince its founding in 1995, it has expanded its services from drug discovery research to clinical development, and it conducts non-clinical studies at its own research facilities.

Characteristics of QPS preclinical contract testing services

Support the evaluation of candidate compounds from pharmacological tests

In QPS,Pharmacological efficacy studies using disease modelsincluding [X], we support a wide range of evaluations from early drug discovery to the development stage. In particular, we utilize in-house developed and validated disease models across multiple therapeutic areas, including the central nervous system. We design test systems to evaluate the effects of candidate substances, such as low-molecular-weight compounds and biologics. Another key feature is our ability to structure non-clinical evaluations as a single research program through collaboration with our DMPK and toxicology departments.

DMPK, toxicity, and bioanalysis compliant with GLP

QPS isCRO compliant with GLP/GCPWe are conducting non-clinical studies with regulatory submissions in mind. DMPK capabilities include ADME evaluation, studies using radiolabeled compounds, QWBA, MARG, plasma protein binding, and DDI evaluation. In toxicology, in addition to standard toxicity studies using multiple animal species, we also provide histopathological evaluation and toxicological pathology consulting.

Supporting development that takes into account the regulatory requirements of each country

QPS has research and clinical facilities in the US, Europe, Asia, and other regions,Nonclinical development assuming international regulatory submissionsIt also supports. In bioanalysis, we conduct studies taking into consideration GLP-related regulations and guidance from the FDA, OECD, NMPA, PMDA, and others. Furthermore, we have a proven track record of supporting responses to inquiries from regulatory authorities. Our strength lies in our ability to build development plans that combine not only single studies, but also pharmacology, DMPK, toxicology, and bioanalysis.

An example of a disease model owned by QPS

At QPS Pharmacology,Validated models in various disease areas, including the central nervous systemwe possess. We not only evaluate drug efficacy using models, but also construct study designs tailored to the development stage and mechanism of action of candidate compounds. We also handle comprehensive non-clinical research combined with DMPK and toxicity evaluations.

Examples of non-clinical studies by QPS

Assist with the IND application for medications to treat opioid use disorder

Regarding the treatment for opioid use disorder, QPSThe series of nonclinical studies required for the IND applicationWe have published a case study on the execution of the following: pharmacokinetic and pilot studies were conducted to design toxicity studies, followed by GLP toxicity studies using rodent and non-rodent species. Four GLP toxicity studies, spanning up to 10 months in total, were completed to support the Phase I clinical trial application.

QPS corporate information