Founded in 1995, QPS is a GLP/GCP-compliant contract research organization (CRO) supporting discovery, preclinical and clinical drug development. We provide quality services to pharmaceutical and biotechnology clients worldwide. Our linearly integrated core competencies include: - Neuropharmacology - DMPK - Toxicology - Bioanalysis - Translational medicine - Early Stage Clinical Research - Phase II – IV Clinical Research - Program Management Our regional laboratories and testing facilities are located at our headquarters in Newark, DE, USA; Springfield, MO, USA; Miami, FL, USA; Groningen, The Netherlands; Graz, Austria; Hyderabad, India and Taipei, Taiwan.
Whether your focus is on small molecules, proteins, antibodies, vaccines or oligonucleotides, QPS provides you with a full range of bioanalytical solutions to support the entire spectrum from early discovery, to IND-enabling ADME, to clinical studies.
Our dedicated, skilled and experienced staff ensures that PK drug quantitation studies meet sponsor's requirements and timelines. In addition to timely, high quality data at competitive prices, QPS provides you with direct access to our technical staff, regularly scheduled updates in a format that works for you and prompt, courteous answers to your inquiries.
QPS maintains four advanced bioanalytical facilities in the USA, Netherlands, Taiwan and India, offering strategic solutions to companies with sites or trials overseas and/or wishing to complete off-shore studies in Asia and/or India. Benefit from our worldwide resources through which a portfolio of assay principles is offered to cover your entire global demand in bioanalysis for your clinical studies.
QPS is at the forefront of a wide range of ligand binding assays for a variety of discovery research and drug development studies. Our scientists have extensive experience in the development and validation, under GLP guidelines, of immunoassays and various technology platforms. Our in-depth technical expertise enables us to offer our clients project-based and cost-effective immunoassay services, including:
LC-MS/MS is the method of choice for small molecule drug quantitation because, by definition, any molecules that can be ionized and detected can be quantitated using LC-MS/MS. Although most of the LC-MS/MS methods developed and validated by QPS are for traditional small molecule drugs, we have also developed and validated LC-MS/MS assays for large multiple-charged molecules such as polypeptides and oligonucleotides.
QPS has significant experience with various chemical structures in multiple therapeutic areas. With the increasing emphasis on "active" isomers and "active" metabolites, over 80% of our NCE studies are in the "N-in-1" format and about 15% of our new assays are chiral studies.
QPS currently has 30 LC-MS/MS instruments between QPS Delaware and QPS Taiwan operations. QPS Delaware has 19 API 4000 triple quadrupoles mass spectrometers, as well as UPLC, LC/UV and LC/fluorescent instruments dedicated to regulated studies. Seven other LC-MS/MS instruments, including six API 4000 triple quadrupoles and linear ion trap, are dedicated to discovery, non-regulated and metabolite identification studies. QPS Taiwan has four API 4000 triple quadrupoles for bioanalysis studies.
Studies determining Absorption, Distribution, Metabolism and Excretion (ADME) patterns in laboratory animals and humans are an integral part of the Drug Metabolism and Pharmacokinetics (DMPK) services provided by QPS. These studies are employed at the discovery, candidate selection, Investigational New Drug (IND) enabling and New Drug Application (NDA) stages of a development program.
Many New Chemical Entities (NCEs) can be rapidly screened using the discovery Pharmacokinetics (PK) approach, resulting in more efficient identification of candidates with the most desired ADME properties. By optimizing the lead structures during the candidate selection process, QPS helps to select drug candidates with the best chance of success. Completion of the preclinical DMPK and clinical PK studies will provide an ADME data package that will fully support regulatory IND and NDA submission.
In addition to conducting animal PK studies, QPS performs a comprehensive series of biotransformation and Quantitative Whole-Body Autoradiography (QWBA) studies.
QWBA offers unique insights for investigators by answering key questions related to tissue pharmacokinetics and metabolism, pathology, toxicology, drug delivery and disposition. QWBA studies provide the tissue distribution and pharmacokinetics data required for new drug registration and for predicting human exposure to radioactivity during clinical radiolabeled mass balance studies.
Plasma protein binding in rodent, non-rodent and human
QPS provides drug interaction studies to determine the potential of a substance to alter cytochrome P450 activity. Studies conducted to assess inhibition and induction potential to support discovery and development of new drug candidates are:
In vitro inhibition of CYP in human liver microsomes (determine IC50)
In vitro reaction phenotyping using both recombinant CYPs or UGTs or other enzyme systems and human liver microsomes and chemical inhibitors using non-labeled and radio-labeled test articles
In vitro metabolic stability in hepatic subcellular fractions to determine intrinsic clearance.
Clinical Trials, Consulting, and Management Services
Biomolecular Interaction Analysis Services
Liquid Chromatography Coupled Mass Spectrometry Methods Services
Biochemistry & Molecular Biology Services
QPS, LLC has not received any reviews.
QPS, LLC has not received any endorsements.