Bioanalytical Method Validation of a Small Molecule in a Surrogate Matrix by LC-MS/MS

Dr. Ryan Chu, the Director of Chemistry at Emery Pharma, will be presenting on the topic of bioanalytical method validation of small molecules using a surrogate matrix using LC-MS/MS. In his presentation, Dr. Chu will discuss the importance of method validation, considerations before starting validation, regulatory guidelines to be followed, and various parameters such as specificity, selectivity, linearity, range, carryover, accuracy, precision, parallelism, recovery, dilution integrity, and stability. His expertise in pharmaceutical sciences, specifically in drug metabolism, makes him well-suited to delve into the details of bioanalytical method validation.
About Emery Pharma:
Emery Pharma is a full-service contract research laboratory, supporting the end-to-end development of small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.
Emery Pharma's premium services include analytical, bioanalytical solutions, microbiology & cell biology services, drug and impurity characterization, and general R&D and cGMP/GLP support.
At Emery Pharma, our focus is to find innovative solutions for our Clients’ toughest challenges and tailoring those solutions to fit each Client’s unique needs. Our experienced scientific team will manage the process: from drug discovery, proof-of-concept, data management, data analysis, to gathering insights. The team excels at solving scientific challenges, and addressing any issues early in the process, so Clients don’t experience unnecessary setbacks.
Emery Pharma’s experienced chemists and biologists deploy state-of-the-art technology. Instrumentation ranges from high-resolution mass spec (Orbitrap), Triple quad LC-MS/MS, GC-MS, Preparative HPLC, and 400 MHz multinuclear NMR.
Contact us: [e-mail]
emerypharma.com/
keyword:
bioanalytical method validation
small molecules
surrogate matrix
LC-MS/MS
method validation
considerations
regulatory guidelines
specificity
selectivity
linearity
range
carryover
accuracy
precision
parallelism
recovery
dilution integrity
stability
pharmaceutical sciences
drug metabolism
Emery Pharma

[@dynamoaltis9584]

Thanks Man! That's an excellent explanation to understand the basics in 22 mins. Please post more.

[@bupe_mukuka]

What does spiking mean?

[@arpit.singh1203]

In simple words, adding something. In Immunogenicity testing, you would spike a known drug concentration for specificity/confirmation analysis.