Regulated Bioanalysis: Fundamentals and Practice / AAPS Advances in the Pharmaceutical Sciences Series Bd.26 (PDF)
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Following an introduction to the topic by the editors, the book then covers "non-scientific" aspects of the topic area including the regulations governing this work, logistical and operational aspects of running a regulated bioanalytical laboratory and appropriate laboratory documentation. Next a description of the typically encountered types of bioanalytical samples, analytes and their attributes is provided. This information then sets the stage for a detailed discussion of the analytical platforms and assay types used in the regulated bioanalysis of small and large molecules. Also provided is a discussion of the different analytical phases of the bioanalytical process (i.e. method development including various strategies, pre-study validation and sample analysis).
Stephen Lowes is Senior Scientific Direct of Bioanalysis and ADME Services at Q2 Solutions. He earned his Ph.D. in analytical chemistry from the Open University, United Kingdom. Dr. Lowes started his industrial career at VG Biotech in the UK that became the LC/MS instrument entity of Waters Corporation. He then joined the CRO group that became Advion and focused his career on regulated bioanalysis with particular emphasis on LC/MS. He has remained very connected on regulatory developments in bioanalysis and is a founding member of the Global Bioanalysis Consortium (GBC) and a past-chair of the AAPS Bioanalytical Focus Group. Dr. Lowes has more than 40 peer reviewed publications on bioanalysis and is a frequent speaker at national and international conferences.
- 2017, 1st ed. 2017, 230 Seiten, Englisch
- Herausgegeben: Mario L. Rocci Jr., Stephen Lowes
- Verlag: Springer-Verlag GmbH
- ISBN-10: 3319548026
- ISBN-13: 9783319548029
- Erscheinungsdatum: 24.04.2017
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- Größe: 3.73 MB
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