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Your search keyword '"Malinowski, H"' showing total 4 results
Start Over Author "Malinowski, H" Journal pharmaceutical research
4 results on '"Malinowski, H"'

1. Workshop III Report: Scaleup of Liquid and Semisolid Disperse Systems1

Author

Buskirk, G. A. Van, Shah, V. P., Adair, D., Arbit, H. M., Dighe, S. V., Fawzi, M., Feldman, T., Flynn, G. L., González, M. A., Gray, V. A., Guy, R. H., Herd, A. K., Hem, S. L., Hoiberg, C., Jerussi, R., Kaplan, A. S., Lesko, L. J., Malinowski, H. J., Meltzer, N. M., Nedich, R. L., Pearce, D. M., Peck, G., Rudman, A., Savello, D., Schwartz, J. B., Schwartz, P., Skelly, J. P., Vanderlaan, R. K., Wang, J. C. T., Weiner, N., Winkel, D. R., and Zatz, J. L.

Published
1994

2. Scaleup of Oral Extended-Release Dosage Forms

Author

Skelly, J. P., Van Buskirk, G. A., Arbit, H. M., Amidon, G. L., Augsburger, L., Barr, W. H., Berge, S., Clevenger, J., Dighe, S., Fawzi, M., Fox, D., Gonzalez, M. A., Gray, V. A., Hoiberg, C., Leeson, L. J., Lesko, L., Malinowski, H., Nixon, P. R., Pearce, D. M., Peck, G., Porter, S., Robinson, J., Savello, D. R., Schwartz, P., Schwartz, J. B., Shah, V. P., Shangraw, R., Theeuwes, F., and Wheatley, T.

Published
1993

3. Scaleup of Immediate Release Oral Solid Dosage Forms

Author

Skelly, J. P., Van Buskirk, G. A., 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., Pearce, D. M., Shah, V., Shangraw, R. F., Schwartz, J. B., and Truelove, J.

Published
1993

4. Bioavailability and bioequivalence: an FDA regulatory overview.

Author

Chen ML, Shah V, Patnaik R, Adams W, Hussain A, Conner D, Mehta M, Malinowski H, Lazor J, Huang SM, Hare D, Lesko L, Sporn D, and Williams R

Subjects
Drug Approval, Drugs, Generic, Drugs, Investigational, United States, United States Food and Drug Administration, Biological Availability, Legislation, Drug, Therapeutic Equivalency
Abstract

Bioavailability and/or bioequivalence studies play a key role in the drug development period for both new drug products and their generic equivalents. For both, these studies are also important in the postapproval period in the presence of certain manufacturing changes. Like many regulatory studies, the assessment of bioavailability and bioequivalence can generally be achieved by considering the following three questions. What is the primary question of the study? What are the tests that can be used to address the question? What degree of confidence is needed for the test outcome? This article reviews the regulatory science of bioavailability and bioequivalence and provides FDA's recommendations for drug sponsors who intend to establish bioavailability and/or demonstrate bioequivalence for their pharmaceutical products during the developmental process or after approval.

Published
2001
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