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.
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.
1.13Pharmacokinetic Study Using Humanized Animals
2.1Contracted Synthesis of RI-labeled Compounds
LSIM Safety Institute provides RI-labeled Compounds used as test substance in ADME Studies and Stable Isotope-labeled Compounds used as internal standard substance in TK/PK Studies at a rapid speed and low cost. In order to synthesize high-quality RI-labeled compounds, our experienced medicinal chemists work closely with our partner company, which synthesize those compounds.
We provide technical guidance on ADME experiments (administration of RI labeling compounds, blood sampling, QWBA, and tissue, urine, feces, and bile collection etc.).
2.3Partnership with Nemoto Science Co.,Ltd.
LSIM Safety Institute and Nemoto Science Co. have signed the mutual master subcontract agreement for ADME Studies. This enables us to propose more various technique and flexible timeline for the studies. (Click here for news & topics)
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.
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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