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Guidance On The Storage Stability Data

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General guidance on hold‑time studies

General guidance on hold‑time studies

www.who.int

Storage arrangements should not have deleterious effects on the subsequent processing, stability, safety, efficacy or quality of starting materials, intermediate products and bulk products prior to final packing. Maximum ... data. Studies may extend beyond the chosen maximum but it is not necessary to

  General, Data, Time, Guidance, Stability, Studies, Storage, Hold, General guidance on hold time studies

Annex 10 - ICH

Annex 10 - ICH

database.ich.org

The guidance on Stability testing of active pharmaceutical ingredients and finished pharmaceutical products was published as Annex 2 in the World Health Organization (WHO) Technical Report Series, No. 953, 2009 (1). The aim of these regulatory guidelines is to outline the core stability data

  Data, Guidance, Stability, Stability data

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