RT Journal Article SR Electronic T1 Pre-Approval Inspections/Investigations JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 56 OP 66 VO 45 IS 1 A1 Food and Drug Administration YR 1991 UL http://journal.pda.org/content/45/1/56.abstract AB