International Stability Testing (eBook, PDF)

Redaktion: Mazzo, David J.

• Format: PDF

Produktbeschreibung

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 requiremen

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Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 352
• Erscheinungstermin: 26. August 2020
• Englisch
• ISBN-13: 9781000122961
• Artikelnr.: 59808289

Autorenporträt

David J. Mazzo

Inhaltsangabe

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.