The FDA has just recently released a guidance document including a Q&A on the use and evaluation of internal standards specifically for bioanalysis. As this is a critical attribute of bioanalytical methods, this is therefore a very important guidance from the agency. Here at Lovelace we have been working with a number of industry experts on the proper evaluation and use of internal standards during the method development, method validation, and sample analysis life cycle of a bioanalytical method.
Contact Lovelace Biomedical to learn more about how work and adhere to these methods and industry standards. We can find the answer to your bioanalytical needs.
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