Pharmacokinetic Assay Service

Medicilon pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vivo pharmacokinetics. The pharmaceuticals department provides customers with high quality pharmacokinetic services from all small molecules to macromolecules (proteins and antibodies), including in vitro ADME and in vivo pharmacies and Bioanalysis which involved animal species are non-human primates, dogs, mice, rats, rabbits, guinea pigs and so on. The non-primate platform and the use of isotope protein / antibody experimental platform by the Shanghai municipal government was identified as an important laboratory platform.

Medicilon’s pharmacokinetics mainly studies changes in drug metabolism in vivo, including the process of drug absorption, distribution, metabolism and elimination (ADME) in vivo. The purpose of Medicilon is to provide high-quality data and rapid turnover to support the drug development, preclinical research and clinical research. Our ultimate goal is to provide customers with not only the strong effect and less toxic side effects, but also the pharmacokinetic properties of the drug.

Pharmacokinetic Services include:

• Preclinical pharmacokinetics,

• The use of isotope-labeled pharmacokinetic studies

• New drug clinical pre-pharmacokinetic data.

Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and Bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai Government.

Available Studies Include:

• Excretion Studies;

• Tissue Distribution;

• Plasma Protein Binding Studies;

Bioanalysis:

• Advanced Bioanalytical Method Development;

• Advanced Bioanalytical Method Validation;

• Pharmacokinetics;

Available Studies Include: Method Development and Validation (GLP & Non-GLP)

i) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration); Stability in Vehicles and Plasma; Drug Interaction Studies; in vitro Metabolic Stability; Prediction and Identification of Major Metabolites; Toxicokinetics Analysis; Distribution Studies;
ii) Pharmacokinetics Package for IND Filing: DMPK package for CFDA and FDA IND filing; Chemical Compounds; Traditional Chinese Medicine; Protein; Antibody;
iii) Metabolic Stability Services: CYP Reaction Phenotyping; Microsomal Stability;S9 Stability; Hepatocyte Stability; Plasma Stability; Metabolite Profiling & Identification;
iv) Drug-Drug Interaction Services: Cytochrome P450 and UGT Reaction Phenotyping; Hepatocyte Induction; Cytochrome P450 Inhibition; Time Dependent Inhibition (Single Point);
v) Permeability and Transporter Services: Caco-2 Permeability; P-gp Inhibition; Available Reaction Phenotyping Services Include: Phase I: Cytochrome P450 Enzymes (CYP); Phase II: UDP-glucuronyltransferases (UGT);
vi) Metabolic Stability: Microsomes Stability; Hepatocytes Stability; Plasma Stability;S9 Stability; Protein Binding Services: Plasma Protein Binding; Brain Tissue Binding; Whole Blood Binding; Blood to Plasma Ratio;

Pharmacokinetic research directions: in vivo research, in vitro research.

In vitro study of pharmacokinetics

Mainly include drug metabolic stability in the body, P450 induction and inhibition, metabolic pathway research, metabolic product identification and other research projects, involving animals include rats, mice, rabbits, dogs, monkeys and so on.

in the body, P450 induction and inhibition, metabolic pathway research, metabolic product identification and other research projects, involving animals include rats, mice, rabbits, dogs, monkeys and so on.

Evaluation capacity: Medicilon completes an average of 8 overall outsourcing studies for new drug applications and more than 1,000 individual studies for new drug applications each year. The tested varieties include small molecule drugs, biotechnology drugs and natural product drugs

Software application: WinNolin and WastonLim software are used for data processing and analysis of pharmacokinetic research and laboratory management

Pharmacokinetics in vitro research service

• Determination of plasma protein binding rate

• Plasma stability test

• Microsomal metabolism test

• CYP450 inhibition test

• CYP450 induction experiment

• Metabolism speculation

• Confirmation of metabolites

• Metabolic pathway speculation

• Confirmation of metabolic pathways

• Transmembrane Transport Experiment

• Drug-drug interaction

Pharmacokinetic in vivo studies

Evaluation ability: Medicilon puya completes an average of 8 Package studies for new drug declaration and more than 1,000 individual studies for new drug declaration each year. The tested varieties include small molecule drugs, biotechnology drugs and natural product drugs

Software application: WinNolin and WastonLim software are used for calculation processing and analysis laboratory management of pharmacokinetic data

Pharmacokinetics in vivo research service project:

• Plasma Kinetics Study

• Organizational distribution research

• Excretion study

• Pharmacokinetic