Výsledky vyhledávání - "Thomas H. Hassall"

Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper

Autor: Taryn A. Rogalski-Salter, Jennifer L. Stotka, Cathie Schumaker, David M. Cocchetto, Thomas H. Hassall, John R. Cutt, Linda Carter

Publikováno v: Drug Information Journal. 42:13-21

Advisory Committees to the Food and Drug Administration provide FDA with expert advice on medical and scientific topics relevant to FDA's responsibility to protect and promote the public health. The history and experience with Advisory Committees (si

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::41e2e6a2c9452790e87de8b14834772d
https://doi.org/10.1177/009286150804200104

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Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper

Autor: Donna Peterson, Thomas H. Hassall, Jennifer L. Stotka, Diane Zezza, David M. Cocchetto, Gregory Brophy

Publikováno v: Drug Information Journal. 42:3-8

The process of development, manufacturing, registration, distribution, and postmarketing support of drug and biologic products includes the need for clear, active, and ongoing communication between the sponsor/applicant and the Food and Drug Administ

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2f4da5400bc95fd2c2f6c01f44616ed9
https://doi.org/10.1177/009286150804200102

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A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments

Autor: Thomas H. Hassall, Peter M. Fairfield, Mark Bokelman, Jennifer L. Stotka, Michelle Folz

Publikováno v: Drug Information Journal. 42:23-26

This article outlines the current process for tracking and reporting postmarketing commitments (PMCs) by the US Food and Drug Administration (FDA). In addition, it summarizes a recent Pharmaceutical Research and Manufacturers of America (PhRMA) compa

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e3519ab7d432bed13de474294e34082c
https://doi.org/10.1177/009286150804200105

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Evaluation of Three Types of Control Chart Methods in Unit Dose Error Monitoring

Autor: Charles E. Daniels, Thomas H. Hassall

Publikováno v: American Journal of Health-System Pharmacy. 40:970-975

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::5392f85bfdc9f8c648b20e6b9b0f690a
https://doi.org/10.1093/ajhp/40.6.970

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Effects of Simulated Facility-Design Changes on Outpatient Pharmacy Efficiency

Autor: Thomas H. Hassall, Kenneth N. Barker, Joseph F. Gallelli, Alex C. Lin

Publikováno v: American Journal of Health-System Pharmacy. 45:116-121

The potential effects of using the Baker drug counter or the Systamodule pharmacy fixture, or both, on the efficiency of the current outpatient pharmacy system at the National Institutes of Health were evaluated by computer simulation. It was hypothe

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::62c9786ae661a3b46cb55649b483b12c
https://doi.org/10.1093/ajhp/45.1.116

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Colorimetric Analysis of Norethindrone, Norethindrone Acetate, and Norgestrel in Oral Contraceptives

Autor: Robert V. Smith, Thomas H Hassall, Shuing Carol Liu

Publikováno v: Journal of AOAC INTERNATIONAL. 53:1089-1092

A colorimetric method, based on reaction with blue tetrazolium, has been devised for the analysis of norethindrone, norethindrone acetate, and norgestrel. The technique is selective for these progestins, showing no interference from the estrogens eth

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::af778bb2a8021c087cf4b64b192035ab
https://doi.org/10.1093/jaoac/53.5.1089

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