Shanghai Medicilon Inc.

  Bioavailability is defined as the rate and the absorption of drug that reaches the biological system in an active form, capable of exerting the desired pharmacological effect, including its onset, intensity and duration of its action. The Need for Bioavailability Studies Bioavailability studies provide and estimate of the fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the bioavailability for a solution, suspension, or intravenous dosage form that is completely available Bioavailability studies provide other useful information that is important to establish dosage regimen and to support drug labeling, such as distribution and elimination characteristics of the drug Bioavailability studies provide information regarding the performance of the formulation Bioavailability Study Protocol The aim of bioavailability study is to find out the dosage form influence on the biological performance of the drug, sensitivity to detect differen

  Medicilon’s   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 etc. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Available PK Studies Include : Method development and validation (GLP,Non-GLP) 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 In Vivo ADME Services

  In vitro metabolism studies can exclude the interference of the body factors for the overall experiment to provide a reliable theoretical basis for the low metabolic rate in vivo, toxic and lack of sensitive detection means of drugs, in vitro metabolism research is a good means of research. At present, in vitro models of drug metabolism include microsomal models, gene recombination enzyme models, hepatocyte models, hepatobiliary perfusion models, Liver tissue sections and so on. Metabolic stability is a key drug property, which is important for both drug administration regiment design as well as toxicity. Species comparison in metabolic stability allows the determination of which animal species is the most appropriate model for the estimation of human metabolic stability of the test article. The use of liver microsomes allows the evaluation of metabolic stability as results of phase I oxidation. The use of hepatocytes allows the evaluation of both phase I oxidation and phase II conju

  Cytotoxicity Assays   are widely used by researchers and by the pharmaceutical industry to investigate the   toxicity   of compounds on cellular systems.   Cytotoxicity assays   provide a rapid, sensitive and validated approach to quantify harmful-dose ranges of compounds and to analyze the biological effects of toxicity on living cellular systems. Additionally,   cytotoxicity testing   can be used for quality control purposes for lot release testing of raw materials or of manufactured drug products. Medicilon can offer multiple readouts for quantifying the  cytotoxicity of compounds , including colorimetric, fluorescent and luminescent assays that can be multiplexed with apoptosis or viability measurements. Our wide range of testing platforms includes the MultiTox-Glo Multiplex Cytotoxicity Assay and the ApoGlow, MTT, XTT, MTS, and LDH assays. Available Cytotoxicity Assay: Agarose Overlay MEM Elution Direct Contact Cytotoxicity Indirect Contact Agar Diffusion Test MTT Assay (quantit

DMPK     or Drug Metabolism and  Pharmacokinetics   is a major part of studies related to drugs often referred to as   ADME   (Absorption, Distribution, Metabolism and Elimination). It is concerned with the study of aspects of absorption, distribution, metabolism and elimination of drug compounds which are administered through any route of administration. Drug Metabolish and Pharmacokinetics are specific to  drug discovery ; drug properties such as route of administration, dose level, dose regimen and  formulation , drug-drug interactions and specific populations are all tightly related to  DMPK  and are therefore measured by our experts. Our  DMPK  Department is dedicated to the understanding of the absorption, distribution, metabolism and excretion of drug candidates. Medicilon’s Pharmacokinetics Services Medicilon’s  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