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Subject Index

abbreviated new drug applications (ANDAs) assessment process, 3, 13–22, 162 basis for submission, 13 case report forms, 16 chemistry, manufacturing and controls/pharmaceutical quality, 14–16 drug master file (DMF), 18–19 filing, 17, 18 financial certification or disclosure statement, 16 format and ...

Publication details


Print publication date
28 Aug 2019
Copyright year
2019
Print ISBN
978-1-78801-433-5
PDF eISBN
978-1-78801-644-5
From the book series:
Drug Discovery