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Regulasi BE TGA_guidance-15-biopharmaceutic-studies

REGULASI BE_FDA_Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-—-General-Considerations.pdf

PER KBPOM_NO.HK.00.05.3.1818 TH 2005_Tentang PEDOMAN UJI BIOEKIV_2005 (3).pdf

CFR - Code of Federal Regulations Title 21

Production, Capacity and Material Planning.pdf

Overview of the capacity planning process for production data