References
- Skelly J. P. G. A., Van Burskirk Savello D. R., Amidon G. L., Arbit H. M., Dighe S., Fawzi M. B., Gonzalez M. A., Malick A. W., Malinowski H., Nedich R., Peck G. E., Peace D. M., Shah V., Shangraw R. F., Schwartz J. B., Truelove J. Workshop Report, Scale-up of immediate release oral solid dosage forms. Pharm. Res. 1993; 10(2)313–316
- Amidon G. L., Lennernas H., Shah V. P., Crison J. R. A theoretical basis for a biopharmaceutical drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 1995; 12(3)413–420
- Scale-up and post approval changes (SUPAC-IR) guidance. Fed. Regist. 1995; 60(230)61638–61643
- Augsburger L. L., Shangraw R. F., Lesko L. J., Williams R. L. An approach toward establishing a scientific foundation for interpreting regulations and workshop on scale-up and post approval changes. Pharm. Res. 1994; 11(10)S–143
- Windholz M. The Merck Index11 th ed. Merck and Co., Inc., Rahway, NJ 1989
- Walle T., Conradi E. C., Walle U. K., Fagan T. C., Gaffney T. E. 4-hydroxypropranolol and its glucuronide after single and long-term doses of propranolol. Clin. Pharmacol. Ther. 1980; 27(1)22–31
- Rekhi G. S., Ashraf M., Augsburger L. L., Schwartz P., Lesko L. J. Identification of critical formulation and processing variables for propranolol hydrochloride tablets. Pharm. Res. 1994; 11(9)S–163
- Physician's Desk Reference48th ed. Medical Economics Data Production Co., Montvale, NJ 1994
- United States Pharmacopeia22nd ed. The United States Pharmacopeial Convention, Rockville, MD 1990
- Guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design. FDA, Office of Generic Drugs (OGD). Division of Bio-equivalence, Rockville, MD 1992
- Peck G. E., Baley G. J., McCurdy V. E., Banker G. S. Tablet formulation and design. Pharmaceutical Dosage Forms: Tablets, H. A. Leiberman, L. Lach-Man, J. B. Schwartz. Marcel Dekker, Inc., New York 1989; Vol 1: 109
- Mehta A. M., Augsburger L. L. A preliminary study of the effect of slug hardness on drug dissolution from hard gelatin capsules filled on an automatic capsule-filling machine. Int. J. Pharm. 1981; 7(4)327–334
- Shangraw R. F. Compressed tablets by direct compression. Pharmaceutical Dosage Forms: Tablets, H. A. Leiberman, L. Lachman, J. B. Schwartz. Marcel Dekker, Inc., New York 1989; Vol 1: 214–217
- Singh Rekhi G., Eddington N. D., Fossler M. J., Schwartz P., Lesko L. J., Augsburger L. L. Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolot tartrate immediate release tablet formulations. Pharm. Dev. Technol. 1997; 2(1)11–24
- Eddington N. D., Rekhi G. S., Demarest D. A., Jr, Leslie J. L., Kharidia J., Shah V. P., Lesko L. J., Augsburger L. L. The influence of scale-up on the in-vivo bioavailability of propranolol hydrochloride tablets. Pharm. Res. 1996; 12(9)S–416