Bioanalytical Method Validation and related areas.
Validation of Analytical Procedures: Methodology (1996) Step 4, Consensus Guideline (obtained from EMEA)
Guidelines for the Design and Evaluation of Oral Prolonged Release Dosage Forms (1988) (pdf file)
Japanease Orange Book English Version
NIHS Nanomedicine regulatory science research
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Last edition: Jul. 12, 2012