WuXi AppTec is looking forward to this year's American Association of Pharmaceutical Scientists (AAPS) annual meeting—known as "PharmSci 360"—on Oct. 17-20. PharmSci 360 is being held at the Pennsylvania Convention Center located in Philadelphia's Center City...
In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...
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Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can...
Preclinical drug-drug interactions (DDI) studies provide preliminary analysis and predict risk potentials for the investigated compounds when co-administrated with other drugs during future in-human trials. Knowledge pertaining to DDI studies is still rapidly...
Protein quantitation by liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become an increasingly popular field for pharmacokinetics study in the drug discovery phase. Traditional method development using a ligand binding assay usually requires 2-3 months....
Immunogenicity assessment helps drug developers understand the possible immune responses that can occur when humans are exposed to a potential therapeutic protein. Recently, the FDA has updated its guidance for immunogenicity risk assessment for developing and...
In 2019, the U.S. Food and Drug Administration (FDA) revised its guidance for immunogenicity risk assessment (IRA) of biological therapies. IRA is required to help drug developers and regulatory agencies better understand the potential impact an immune response will...