From drug discovery, through to preclinical and clinical studies, understanding drug exposure and behaviour are imperative to dose selection, and accelerating drugs to clinic and commercialization. Bioanalysis is an integral part of the drug development process, particularly in early development where it is used to support preclinical and FIH studies to determine metabolic fate and pharmacokinetics of the drug.
Through the use of robust bioanalytical techniques, biological samples can be processed and analyzed to identify and quantify compounds of interest, such as small molecules and their metabolites, as well as peptides, proteins, nucleic acids and other analytes. Bioanalysis can be utilized as both a stand-alone service or part of a fully integrated development program, as it plays a pivotal part in providing important bioanalytical data that aids in the formulation design.
Delivering rapid bioanalytical data is critical when trying to rapidly get medicines to patients faster. At Quotient, we utilize a integrated approach, by combining bioanalysis with toxicokinetics and pharmacokinetics (TK/PK) reporting and human ADME, to streamline the drug development process and to ensure that critical decision-making data is rapidly processed, robust and reliable.
Join Quotient’s Vice President of Bioanalysis, Dr Stuart McDouggal, as he discusses how best to leverage bioanalysis within drug development programs to accelerate timelines & enhance the likelihood of clinical & commercial success.
This webinar will provide an in-depth look at key strategies, including:
- Lifecycle and evolution of bioanalytical assay during a drug development program
- Quality and compliance; understanding the regulatory requirements at each stage of development
- Science & knowledge; the value that experienced method developers can add to a program to enhance sensitivity, selectivity & speed of assay
- Experience & accountability; bioanalytical program managers leading trained and highly motivated bioanalysts to deliver on-time analysis and data of the highest quality
- Future direction / new frontiers for bioanalysis
