LIGNES DIRECTRICES

Pharma Stability

Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
Pharma Stability

VICH GL58 (Quality - Stability) - November 2019 - for implementation at step 7 in the regions by November 2020

Télécharger GL58-st7corr-2.pdf


Statistical evaluation of stability data
Pharma Stability

VICH GL51 (Phramaceuticals - Quality: Stability Data) - February 2013 - Implemented in February 2014

Télécharger GL51-st7.pdf


Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
Pharma Stability

VICH GL45 (Pharmaceuticals - Quality) - April 2010 - Implemented in April 2011

Télécharger GL45-st7.pdf


Stability Testing: Photostability Testing of New Drug Substances and Products
Pharma Stability

VICH GL5 (Quality - Stability) - Implemented in May 2000

Télécharger gl05_st7.pdf


Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)
Pharma Stability

VICH GL3(R)  (Quality - Stability) – Implemented in January 2008

Télécharger GL03_ST7R.pdf


Stability Testing: Requirements for New Dosage Forms
Pharma Stability

VICH GL4 Annex to the VICH guidelines on Stability Testing for New Drugs and Products (Quality - Stability) - Implemented in May 2000

Télécharger gl04_st7.pdf


Stability Testing for Medicated Premixes
Pharma Stability

VICH GL8 (Quality - Stability premixes) November 1999 - Implemented in June 2001

Télécharger GL08_ST7.pdf


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