Nonclinical Services

Pharmacokinetic Studies

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.

Services Available

• 1.Pharmacokinetic Studies

  • 1.1ADME Studies (Absorption, Distribution, Metabolism, Excretion)
  • 1.2Placental/Fetal Transfer, Milk Secretion
  • 1.3Pharmacokinetic Study Using Humanized Animals
  • 1.4Plasma Protein Binding
  • 1.5Blood Cell Distribution
  • 1.6Drug-metabolizing Enzyme Inhibition
  • 1.7Drug-metabolizing Enzyme and Isoform Identification
  • 1.8In Vitro Human CYP Induction
  • 1.9In Vitro Skin Permeability
  • 1.10Metabolite Profiling in Biological Samples

• 2.Other Service

  • 2.1Knowledge Service

    We provide technical guidance on ADME experiments (administration of RI labeling compounds, blood sampling, QWBA, and tissue, urine, feces, and bile collection etc.).

  • 2.2Partnership 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)

Toxicokinetic / Pharmacokinetic Studies

• 1.Development of Bioanalytical Method

  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.

• 2.Bioanalytical Method Validation

  Validations of bioanalytical methods are conducted in accordance with domestic and international guidelines.

• 3.Bioanalysis of Biological Samples

  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.

• 4.Nonclinical Pharmacokinetic Studies

  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.

• 5.Clinical Pharmacokinetic Studies