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Commercial bioanalytical laboratories may typically create and validate scientifically rigorous methods fast, then seamlessly integrate those methods into sample runs within weeks or even days after the original project inquiry, depending on the type of project and substance.
FREMONT, CA: Given today's time constraints and the high cost of discovery and development in biopharmaceutical research, supporting services such as bioanalysis are more crucial than ever to ensure speed and success. Simply put, bioanalysis is the quantitative measurement of an active drug in a biological matrix; it is necessary for the evaluation of a medicinal entity throughout the drug development cycle. The focus is on research in the early stages of discovery, lead optimization, and nonclinical development: developing and improving analysis methods that will accurately and efficiently assess the drug level in various species and biological matrices.
As research progresses from nonclinical to clinical trials, the bioanalytical assistance required changes as well. The problems of sample transport and handling from complicated, multi-site, often multi-country trials, as well as significant data management needs, necessitate logistical expertise in addition to scientific skill in the later stages of research (Phases II-IV).
Bioanalytical sciences like feasibility and technique development help critical pharmaceutical evaluations, such as toxico- and pharmacokinetics, bioavailability, drug-drug interaction investigations, and other systematic assessments. Lead times must be carefully handled in nonclinical and clinical product development due to the enormous volume of work involved. Many pharmaceutical and biotechnology companies now outsource at least some of their bioanalytical requirements. Bioanalytical services outsourcing can be done strategically or tactically, depending on business, financial, and technological reasons.
Outsourcing as a strategy aids in the management of the ebb and flow of projects entering or exiting product development owing to toxicity, economics, or shifting priorities. It could help amortize the strengths of a specific outsourcing partner by providing additional scientific and operational expertise that can aid in making go/no-go choices. Commercial bioanalytical laboratories may typically create and validate scientifically rigorous methods fast, then seamlessly integrate those methods into sample runs within weeks or even days after the original project inquiry, depending on the type of project and substance.
Depending on the laboratory's capabilities, projects beginning for established, validated assays may begin right away. Sponsors benefit from bioanalytical outsourcing because it gives them more flexibility, global access, and lower people and capital infrastructure costs while extending scope and capabilities that may not be available internally.
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