Overview

Pharmacokinetic (PK) and Immunogenicity (ADA Assay) are critical components in the drug development lifecycle. FDA, NMPA, and other regulatory agencies require proof of the effectiveness and safety of the drugs in animal models before drugs enter clinical research. Therefore, it is essential to study the pharmacokinetics of drugs and to conduct immunogenicity risk assessment during the IND stage and Phase I clinical trials.

GenScript provides PK and ADA assay kits for preclinical and clinical analysis of drugs, as well as raw materials for method development and establishment of PK and ADA Assay. GenScript's products and services will help you better study the drug metabolism, evaluate drug distribution and metabolism in vivo, and detect the risk of immune reactions caused by drugs.

As your drug development partner, GenScript can provide early guidance for clinical research by developing and establishing reliable non-clinical analytical assessment methods to enhance drug safety and efficacy. GenScript is dedicated to offering high-quality, dependable reagent products and method development support to assist you in achieving success in the drug development process.

Features

Minimize risk

Minimize risk


Minimize the risk of replacing raw materials

Save time

Save time


Save the time for raw materials selection and method development

More professional

More professional


Develop the kit products according to FDA and NMPA regulations

Easier to Operate

Easier to Operate


Easy to operate and reduce operating errors

Figure 1. Development process of antibody drug

Kits Development and Validation

GenScript PK/ADA kits are developed and validated according to FDA and NMPA regulations, and accuracy of kits is evaluated according to the guidance document CLSI EP05-A3 to ensure its accuracy and reliability. GenScript PK/ADA kits can satisfy the needs of PK and ADA research during preclinical and clinical research.

Applications

Product List

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