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Bioanalytical Method Development
For Preclinical & Clinical Programs
Selective and sensitive analytical methods are critical to sound quantitative evaluations of drugs and metabolites, and unfortunately can be a source of delays expense and frustration--especially when transferred between laboratories, used for incurred sample analysis or when adapted to new species or matrices.
ABC has developed and validated hundreds of proprietary methods in support of preclinical and clinical development, for more than 25 drug classes and across every biological matrix. Our approach to method development combines proven scientific practice with ingenuity, applying extensive experience in HPLC-UV, LC-MS/MS, as well as ELISA and RIA techniques to deliver methods that will produce reliable, repeatable results at the lower limit of quantification (LLOQ). Over the years, our team of method development experts have successfully resolved many validation challenges when other CROs could not.
When you visit ABC Laboratories, you will find a modern, GLP-compliant facility and Standard Operating Procedures that strictly adhere to current FDA guidance. Our scientists and QA professionals work according to well-defined business processes that promote continuous quality improvement, timely delivery and transparent communication.
ABC Laboratories supports IND-enabling and clinical programs with bioanalytical methods for use in dose formulation analysis and interference testing, non-human pharmacology and toxicology studies, as well as human clinical pharmacology, bioavailability, and bioequivalence studies requiring pharmacokinetic evaluation.
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Active participants in Crystal City meetings and technical discussion groups, our bioanalytical scientists deliver methods that are reliable, repeatable and robust. |
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