Ebook SOLID DOSAGE DRUG DEVELOPMENT AND MANUFACTURING ini berisi tentang hal-hal yang berhungan dengan produksi sediaan padat. Berikut daftar isinya:
EXCIPIENTS
4 Excipient Quality and Selection
Irwin B. Silverstein
EXCIPIENT DATABASES
16 Unifying Excipient Databases
Agnes Shanley
NON-GELATIN CAPSULES
20 Establishing a New Performance
Standard for HPMC Capsules
Agnes Shanley
PROCESS SIMULATION
22 Modeling and Simulation
Move Downstream
Agnes Shanley
TABLET COMPRESSION
26 Optimizing Tablet Compression
Frederick J. Murray
CONTINUOUS MANUFACTURING
34 Filling the Analysis Gap in
the Move to Continuous Processing
Jamie Clayton
ELEMENTAL IMPURITIES
40 Meeting USP Guidelines for
Elemental Impurity Analysis with
X-ray Fluorescence Spectrometry
Andrew Fussell
GENERIC DRUGS
46 Regulatory Considerations for Controlling
Intermediates in Type-II Drug Master Files for
the Manufacture of Generic Drug Substances
Kandasamy Subburaj, Brian T. Connell, Srinivasa Murthy, Humcha
Hariprakasha, Deborah F. Johnson, Huyi Zhang, and David J. Skanchy
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M. Fithrul Mubarok, S.Farm.,Apt
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