LSIM Safety Institute conducts pharmacokinetic (ADME) studies under the management system certified with GLP or in compliance with GLP. We have an extensive menu of in vivo and in vitro pharmacokinetic studies and drug-drug interaction (DDI) studies for safety evaluation of pharmaceuticals and agricultural chemicals, etc.
Radioisotope (RI)-labeled compounds used in ADME studies are able to be synthesized at Curachem Inc. through advanced radiochemical techniques and technology while our experienced medicinal chemists supervise and support overall operations. We are also able to conduct studies using non-labeled compounds for evaluation of pharmacokinetics utilizing analysis technique such as LC/MS/MS and bioassay.
Furthermore, we have started to offer technical guidance (knowledge service) on ADME experiments (administration of RI labeling compounds, blood sampling, QWBA, and tissue, urine, feces, and bile collection etc.).
We continue to satisfy the diverse needs in various aspects of our clients’ research and development projects while keeping an eye on the latest technologies, various guidelines, and regulation trends. Please contact us with any inquiries or requests.
-RI-labeled compounds can be synthesized fast, at low cost and high quality at Curachem with advanced radiochemical technology.
-Our experienced medicinal chemists through overall supervision of the process ensure smooth operations.
2.16Pharmacokinetic Study Using Humanized Animals
-High-quality 125I-labeled antibodies and 14C-labeled antibody drug conjugates (ADCs) can be provided fast at low cost.
-We have a wealth of experience in ADME studies using cynomolgus monkeys. Additionally, various kinds of tumor-beaning model mice can be prepared upon request.
-We conduct bioanalysis studies such as immunoassay and measurement of ADCs (ELISA, ECL, and SPR).
-Evaluation of antibody functions such as ADCC and CDC activities is also available at LSIM.
Based on the structure of the drug or information provided, we develop a bioanalytical method which mainly utilizes LC/MS/MS instruments. We also investigate processing methods of bioanalytical samples such as plasma, blood, urine and tissue as well as analysis conditions of instruments.
Validations of bioanalytical methods are conducted in accordance with domestic and international guidelines.
Bioanalysis is conducted in compliance with GLP using validated analysis methods.
Toxicokinetic studies are conducted under the same GLP conditions as safety studies at the same facility. Multi-site studies are also available. We have a wealth of experience with various species of animals.
A diverse range of studies including pharmacokinetic studies using animals, bioavailability studies, bioequivalence studies, and DDI studies are available. Pharmacokinetic measurement of clinical samples is also available at LSIM. Please contact us with any inquiries or requests.
-LC/MS/MS: 25 units
|Model (Manufacturer)||Owned number|
|Triple Quad 5500 (SCIEX)||3|
|QTRAP 5500 (SCIEX)||2|
We provide information for clients concerning development of pharmaceuticals, agrichemicals, and chemical substances etc.
Please note and understand that we cannot respond to requests from competitors or free e-mail addresses.
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