International Stability Testing (e-bok)
Fler böcker inom
Format
E-bok
Filformat
EPUB med Adobe-kryptering
Om Adobe-kryptering
Nedladdning
Kan laddas ned under 24 månader, dock max 3 gånger.
Språk
Engelska
Antal sidor
352
Utgivningsdatum
2020-08-26
Förlag
CRC Press
ISBN
9781000161663

Du kanske gillar

International Stability Testing (e-bok)

International Stability Testing E-bok

av David J Mazzo
E-bok (EPUB - DRM), Engelska, 2020-08-26
617
Ladda ned
Spara som favorit
Laddas ned direkt
Läs i vår app för iPhone och iPad
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