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Search results with tag "Drug registration"
Demystifying FDA’s 505(b)(2) Drug Registration …
djaglobalpharma.com1 October 2009 Demystifying FDA’s 505(b)(2) Drug Registration Process By Harriette L. Nadler, PhD and Damaris DeGraft-Johnson, RPh, MSc
Guidelines on Drug Registration Applications in Botswana 2014
www.moh.gov.bwAnalytical validation: This is a demonstration with documentary evidence that an analytical procedure leads to the expected results. Anatomic-Therapeutic Chemical Classification(ATC): This is a classification of drugs according to site of action (anatomical), therapeutic indication …
ASEAN GUIDELINE ON SUBMISSION OF …
www.hsa.gov.sg2 GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION 1. INTRODUCTION Process Validation is a means of ensuring that manufacturing processes are capable of consistently