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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Handbook of Stability Testing in Pharmaceutical Development - Regulations, Methodologies, and Best Practices (Hardcover, 2009 ed.)
Loot Price: R5,943
Discovery Miles 59 430
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Handbook of Stability Testing in Pharmaceutical Development - Regulations, Methodologies, and Best Practices (Hardcover, 2009 ed.)
Expected to ship within 10 - 15 working days
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In my professional career as a pharmaceutical scientist, I have
been involved with severalaspectsofthe
drugdevelopmentprocessfrompre-INDto commercialization and, somehow,
I usually found myself coming back to a stability-related issue.
The stability area seemed to draw my utmost interest because in my
day-to-day work, my opportunities involved more than one product,
and none of the issues were the
same.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment,
an understandingof regulations, a knowledgeof science, a graspof
compliance, and an appreciation of common practices.
Sinceearly2000,
Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand I
struggled to ?nd good, concise, practical resources, one of which I
could just hand to a new scientist who wishes to gain a greater
understanding of stability sciences. In addition, I encountered the
same questions posted over and over on different stability best
practices discussion forums. As a book lover, I also have a good
collection of technical books. Unfor- nately, most of the stability
related volumes are outdated. Many of these materials are
theoretical and do not contain much practical information. I
understand that the pharmaceutical industry during this period is
quite volatile, and guidelines are
changingrapidlywhileregulatoryagenciesareworkingcloselywiththepharmac-
tical industryto accommodatethese changes;however,
thefundamentalinformation continues to remain quite the same, just
as current Good Manufacturing Practices (cGMP) continue to be the
standard industry practice. Therefore, I hoped to ass- ble a
practical handbook to ?ll this v
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