Address: 1 Broadway, Cambridge, MA02142 (America)
Tel: +1(626)986-9880
Address: Allia Future Business Centre Kings Hedges Road Cambridge CB4 2HY, UK
Tel: 0044 7790 816 954
Email: marketing@medicilon.com
Address: No.585 Chuanda Road, Pudong New Area, Shanghai (Headquarters)
Postcode: 201299
Tel: +86 (21) 5859-1500 (main line)
Fax: +86 (21) 5859-6369
Date: Saturday, June 3rd, 2023
Location: Boston Marriott Cambridge
Date: June 5-8, 2023
Location: Boston, MA
Booth: 2275-J
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Email:marketing@medicilon.com
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Tel: +86 (21) 5859-1500
Determinand | Description | Typical analysis method |
---|---|---|
Conjugated Antibody | Antibody conjugated to at least one drug | LBA |
Total Antibody | Fully conjugated, partially conjugated and unconjugated antibodies | LBA |
Small Molecules | Free or diluted drug micromolecules and their metabolites | LC-MS/MS |
ADA | Antibodies that can specifically bind ADC molecules and their partial structures | LBA |
The Caco-2 cell line is a human colon adenocarcinoma epithelial cell that can differentiate itself into a monolayer similar to a mature human small intestinal epithelial cell.
(1) Complete absorption (passive absorption is better), bioavailability > 50% and small variation;
(2) AUC is proportional to dose, and PK/PD correlation is clear;
(3) Quickly reach the target organ and do not accumulate outside the target organ;
(4) PPB<90%, not affected by concentration and time;
(5) Plasma clearance CL<30%Qn, cleared through various routes;
(6) Age, race, gender, disease state, etc. have little effect on CL;
(7) metabolite quantity is low and no reactive metabolites are produced;
(8) Does not inhibit or induce major drug metabolizing enzymes and transporters, and is not affected by food;
(9) T1/2>6hr in human body, which can reduce the dosing frequency and improve the compliance.
(1) The liver is the main organ of drug metabolism, but not the only way of drug elimination. There is also renal elimination, etc.
(2) The drug is unstable in the blood, and the clearance of the drug does not have a hepatic effect.
(3) In some cases, when the drug concentration in red blood cells is much higher than that in plasma, the calculation of proper clearance cannot be approximated by the drug concentration in plasma.
(4) In individual cases, metabolism or uptake by the lungs occupies a significant role.
(1) Dose deviation due to administration error.
(2) Nonlinear pharmacokinetics (Nonlinear PK).
(3) High bioavailability and individual variability in the DMPK properties of the drug, with IV and PO, given to different groups of animals.
(4) Overestimation of PO AUC or underestimation of IV AUC due to unreasonable sampling points.
(5) IV samples were left for extended periods, and compounds were unstable in plasma.
(6) When administered as a racemate, the faster-clearing enantiomer is converted to the slower-clearing enantiomer in the GI tract.