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Your search keyword '"Winkle H"' showing total 3 results
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3 results on '"Winkle H"'

1. The FDA Regulatory Methods Validation Program for New and Abbreviated New Drug Applications

Author

Layloff, T., Nasr, M., Baldwin, R., Caphart, M., Drew, H., Hanig, J., Hoiberg, C., Koepke, S., Lunn, G., MacGregor, J.T., Mille, Y., Murphy, E., Ng, L., Rajagopalan, R., Sheinin, E., Smela, M., Welschenbach, M., Winkle, H., and Williams, R.

Subjects
United States. Food and Drug Administration -- Planning, Planning, Company business planning, Pharmaceutical research -- Planning, Drugs -- Planning
Abstract

This article describes the FDA methods validation program for proposed regulatory methods submitted through the new and abbreviated new drug application processes. The program is conducted by the Center for [...]

Published
2000

2. Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report.

Author

Chen ML, Shah VP, Ganes D, Midha KK, Caro J, Nambiar P, Rocci ML Jr, Thombre AG, Abrahamsson B, Conner D, Davit B, Fackler P, Farrell C, Gupta S, Katz R, Mehta M, Preskorn SH, Sanderink G, Stavchansky S, Temple R, Wang Y, Winkle H, and Yu L

Subjects
Pharmaceutical Preparations, Therapeutic Equivalency
Abstract

Modified release products are complex dosage forms designed to release drug in a controlled manner to achieve desired efficacy and safety. Inappropriate control of drug release from such products may result in reduced efficacy or increased toxicity. This workshop provided an opportunity for pharmaceutical scientists from academia, industry, and regulatory agencies to discuss current industry practices and regulatory expectations for demonstrating pharmaceutical equivalence and bioequivalence of MR products, further facilitating the establishment of regulatory standards for ensuring therapeutic equivalence of these products.

Published
2010
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3. Quality by design for biopharmaceuticals.

Author

Rathore AS and Winkle H

Subjects
Biological Products chemical synthesis, Biotechnology methods, Biotechnology trends, Chemistry, Pharmaceutical methods, Drug Design, Humans, Quality Control, United States, United States Food and Drug Administration, Biological Products pharmacology, Biopharmaceutics
Published
2009
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