期刊论文 Common deficiencies in ANDAs for dermatologic drug products复制

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RK Chang, S Rosencrance, A Raw, B Cai, P Simamora
2016
pharmtech.com
Approval of generic drugs can be slowed down by deficiencies in abbreviated new drug applications (ANDAs). Srinivasan et al.(1-4) published a series of articles on common deficiencies in ANDAs that provide clarification, intention, and criticality of common deficiencies found in the Chemistry, Manufacture, and Controls (CMC) section of ANDAs. Liu et al.(5) also published an article on common deficiencies with “Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by Food and Drug …