Search Results - "Uppoor, RS"
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Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications
Published in The AAPS journal (07-10-2005)“…The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling and simulation of data pertaining to…”
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The Use of Imaging in the Early Development of Neuropharmacological Drugs: A Survey of Approved NDAs
Published in Clinical pharmacology and therapeutics (01-07-2008)“…The aim of the study was to evaluate the use of imaging in the development of neuropharmacological drugs. All New Drug Applications (NDAs) approved from 1995…”
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In vitro metabolic interaction studies: Experience of the Food and Drug Administration
Published in Clinical pharmacology and therapeutics (01-07-1999)“…A total of 194 new molecular entities approved by the Food and Drug Administration between 1992 and 1997 were surveyed to determine the role of in vitro…”
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Evaluation of "external" predictability of an in vitro-in vivo correlation for an extended-release formulation containing metoprolol tartrate
Published in Journal of pharmaceutical sciences (01-10-2000)“…The purpose of this study was to examine the external predictability of an in vitro-in vivo correlation (IVIVC) for a metoprolol hydrophilic matrix…”
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In vivo drug-drug interaction studies- A survey of all new molecular entities approved from 1987 to 1997
Published in Clinical pharmacology and therapeutics (01-09-2000)“…Ninety‐eight new molecular entities applications approved between 1987 to 1991 (period I) and 193 applications for new molecular entities between 1992 to 1997…”
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