1. Policy and Procedure Guide #22-90: `Interim Policy on Exception to Batch-size for Non-Antibiotic, Solid Oral Dosage Form Drug Products Supporting Proposed ANDA's' Guidance (FDA, CDER, Office of Generic Drugs (OGD), Rockville, MD, 13 September 1990).
2. Workshop report: scaleup of immediate release oral solid dosage forms;Skelly;Pharm. Res.,1993
3. An approach toward establishing a scientific foundation for interpreting regulations and workshop reports on scale-up and post-approval changes;Augsburger;Pharm. Res.,1994
4. FDA, Guidance for industry—immediate release solid oral dosage forms/scale-up and post approval changes: chemistry, manufacturing, and controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, Guidance effective November 30, 1995.
5. FDA, Guidance for industry—modified release solid oral dosage forms/Scale-up and post approval changes: chemistry, manufacturing, and controls. In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, Guidance effective October 6, 1997.