berikut daftar isinya:
DRUG DEVELOPMENT
Outsourcing: Does Focus Pay Off?
Agnes Shanley 4
COMPLETE RESPONSE LETTERS
Avoiding Complete Response Letters
Agnes Shanley 7
QUALITY
Quality Oversight During
Sterile Filling Operations
Philip Hoersch 11
QUALITY AGREEMENTS
Good Quality Agreements
Support Compliance with CGMP
Paula Katz, Tamara Ely, Linda Joy, and Jessica Ritsick 16
PROCESS VALIDATION
Process Validation in
Biologics Development
Susan Haigney 22
CONTRACT BIOMANUFACTURING
Bigger is Better in Samsung’s
Approach to Biomanufacturing
Rita Peters 24
ANALYTICS OUTSOURCING
Choosing an Analytical Partner
in Early Drug Development
Feliza Mirasol 27
ANALYZING BIOLOGICS
Gaining Analytical Insight
in the Development of Biologics
Susan Haigney 30
MARKET INVESTMENT
Contract Services Investment Update
Amber Lowry
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Semoga bermanfaat
Salam
M. Fithrul Mubarok, S.Farm.,Apt
