Abstract
Bioanalysis spans nearly a century of practice enabling the widespread use of pharmacokinetics and pharmacodynamics to improve the rational use of existing drugs and the development of new drugs. While few universities and colleges offer formal programs in bioanalysis, there are several scientific degree programs that are good entry points into the field. The successful bioanalytical laboratory requires a high degree of scientific talent in addition to professionals capable of tackling operational and sample logistics, project and data management, quality control and quality assurance, metrology, instrument maintenance, information technology, and technical writing. These positions and others afford attractive career opportunities for those contemplating the field. Technology is developing at an amazing rate in the bioanalysis field and it is an exciting time to be engaged in this scientific discipline. Given this rapid pace of change, keeping current with the scientific literature, as well as active participation in professional organizations, focus groups, and scientific conferences and meetings germane to the field is crucial.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
Wagner JG. History of pharmacokinetics. Pharmacol Ther. 1981;12:537–62.
Hill H. Development of bioanalysis: a short history. Bioanalysis. 2009;1:3–7.
Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, et al. Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Pharm Res. 1992;9:588–92. doi:10.1023/A:1015829422034.
Shah VP, Midha KK, Findlay JW, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A. Bioanalytical method validation—a revisit with a decade of progress. Pharm Res. 2000;17:1551–7. doi:10.1023/A:1007669411738.
USA Food and Drug Administration. Guidance for industry: bioanalytical method validation. MD, USA: Rockville; 2001.
Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21:1249–73.
DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20:1885–900.
Smolec J, DeSilva B, Smith W, Weiner R, Kelly M, Lee B, et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm Res. 2005;22(1):425–1431.
Japan, MHLW, Guideline on Bioanalytical Method Validation in Pharmaceutical Development. 2013.
Japan, MHLW, Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development. 2014.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Lowes, S., Rocci, M.L. (2017). Introduction. In: Rocci Jr., M., Lowes, S. (eds) Regulated Bioanalysis: Fundamentals and Practice. AAPS Advances in the Pharmaceutical Sciences Series, vol 26. Springer, Cham. https://doi.org/10.1007/978-3-319-54802-9_1
Download citation
DOI: https://doi.org/10.1007/978-3-319-54802-9_1
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-54800-5
Online ISBN: 978-3-319-54802-9
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)