新药申报临床一般需要有合适的制剂,临床上需要做大量的制剂比较研究,以确证合适的制剂。临床前动物实验可以动态评价制剂在动物体内崩解、吸收、分布、代谢和排泄过程,桥接体外溶出和体内暴露量的关系。
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The SPF and general animal rooms, with more than 600 square meters, can perform experiments on mice, rats, dogs, monkeys, rabbits, small pigs, and many other genera.
Oral gavage, sublingual administration, injection, topical application, whole blood collection, excreta collection, tissue collection, eye tissue collection, cerebrospinal fluid collection, bile duct intubation, etc.
A strict quality management system is in place to ensure the reliability of data and validity of research.
There are more than 400 sets of various instruments such as 16 sets of LC-MS/MS systems, 2 sets of MSD, analytical balances of 1 part in a million and 1 part in 100,000, respiratory anesthesia machines, IVC systems, various incubators, tissue homogenizers, centrifuges and so on.
In vitro metabolic studies, including metabolic studies based on liver microsomes, hepatocytes, liver S9, CYP enzymes, etc;
Analysis of biological samples for PK, tissue distribution and excretion experiments, development and validation of analytical methods, parameter calculations, etc.
The laboratory follows GLP (Good Laboratory Practice) and ISO standards to ensure data reliability and accuracy.
More than 100 bead cell banks have been established.
In vitro cell proliferation inhibition, Caco-2 permeability, and hepatocyte-related experimental studies can be performed.
The laboratory has a cell bank of more than 100 beads. The laboratory strictly follows the experimental practice to ensure the accuracy and reproducibility of the data.
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