International Stability Testing (inbunden)
Fler böcker inom
Format
Inbunden (Hardback)
Språk
Engelska
Antal sidor
352
Utgivningsdatum
1998-08-01
Förlag
CRC Press Inc
Medarbetare
Mazzo, David J. (red.)
Illustratör/Fotograf
illustrations
Illustrationer
illustrations
Dimensioner
266 x 179 x 24 mm
Vikt
804 g
Antal komponenter
1
Komponenter
,
ISBN
9781574910780

Du kanske gillar

International Stability Testing (inbunden)

International Stability Testing

av David J Mazzo
Inbunden Engelska, 1998-08-01
1849
Bevaka
Spara som favorit
Tillfälligt slut – klicka "Bevaka" för att få ett mejl så fort boken går att köpa igen.
Finns även som
Visa alla 2 format & utgåvor
In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.
Visa hela texten

Kundrecensioner

Har du läst boken? Sätt ditt betyg »

Fler böcker av David J Mazzo

  • Analytical Profiles of Drug Substances and Excipients

    Analytical Profiles of Drug Substances and Excipients

    Klaus Florey, Harry G Brittain, David J Mazzo, Timothy J Wozniak, Gerald S Brenner

    Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degrad...

    669
    Ladda ned
    Laddas ned direkt

Innehållsförteckning

ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.