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Book Cover
E-book
Author Rapra, iSmithers

Title Extractables & Leachables for Pharmaceutical Products 2010 : 14-15 September, 2010, London
Published Shrewsbury : ISmithers Rapra Pub., 2010

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Description 1 online resource (196 pages)
Contents First four pages Extractable; Paper 01 -- Forrest; Paper 02 -- Hawkins; Paper 03 -- Nicholas; Paper 04 -- Worsoe; Paper 05 -- Markovic; Paper 06 -- Egert; Papers 7-11 -- Multi Authors; Paper 12 -- Hodgson; Paper 13 -- Martin; Paper 14 -- Stults; Paper 15 -- Feilden; Paper 16 -- Creasey; Paper 17 -- Senholt; Paper 18 -- Jenke; Paper 19 -- Toynbee; Paper 20 -- Claessens; Paper 21 -- Janssen; Paper 22 -- Wong
Summary Impurities originating from any part of the manufacturing or storage of drug products can potentially result in expensive product recalls and damage to a company's reputation - not to mention the serious threat posed to patient safety. Nowadays extractables and leachables assessment of all materials - and especially elastomeric and plastic components - forms an integral part of the submission for approval of a new drug system or medical device. With regulatory authorities such as the FDA and the MHRA demanding assurance that a product's integrity has been scrutinised - the pharmaceutical indus
Notes Print version record
Subject Drugs -- Dosage forms -- Congresses
Leachate -- Health aspects -- Congresses
Drug stability -- Congresses
Drug delivery systems -- Safety measures -- Congresses
Pharmaceutical technology -- Quality control -- Congresses
Pharmaceutical industry -- Quality control -- Congresses
Pharmaceutical policy -- Congresses
MEDICAL -- Pharmacology.
Drug stability
Drugs -- Dosage forms
Pharmaceutical industry -- Quality control
Pharmaceutical policy
Pharmaceutical technology -- Quality control
Genre/Form Conference papers and proceedings
Form Electronic book
ISBN 9781847356123
1847356125