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Extractables and Leachables

Autor Jenke
en Limba Engleză Hardback – 4 noi 2014
This book specifically addresses the safety aspects of compatibility for drugs and their delivery devices and containers. The author deals with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact.
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Specificații

ISBN-13: 9780470281765
ISBN-10: 0470281766
Pagini: 400
Dimensiuni: 163 x 240 x 25 mm
Greutate: 0.67 kg
Editura: Wiley
Locul publicării:Hoboken, United States

Public țintă

Pharmaceutical scientists, analytical scientists, quality control/regulatory affairs, toxicologists, container manufacturing specialists in drug and device companies

Notă biografică

Dennis Jenke is Principal Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. He works with a team of analytical chemistry professionals in areas including the assessment of material/product compatibility, specifically with respect to leachables/extractables and product ingredient binding. He has published extensively in the areas of analytical chemistry, environmental science, and material/solution compatibility; serves as an expert reviewer for numerous pharmaceutical and analytical journals; is a frequently invited speaker in the general areas of analytical chemistry and material/solution compatibility; and is currently an active participant in ongoing collaborative activities designed to establish harmonized best demonstrated practices for extractables/leachables assessment.