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Auburn University, AL, United States

DeRuiter J.,Auburn University | Holston P.L.,Health Information Designs | DeRuiter T.J.,Auburn University
U.S. Pharmacist | Year: 2015

New molecular entities (NMEs), as defined by the FDA, are drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in the past year (TABLE 1) detail the basic clinical and pharmacologic profiles for each new drug, as well as its pharmacokinetics, adverse reactions, drug interactions, and dosing data. Note that the information for each NME was obtained primarily from sources published prior to FDA approval; thus, it is essential that practitioners become aware of changes in a drug’s therapeutic profile as reported by their own patients and in the pharmaceutical literature, such as the emergence of additional adverse reactions and boxed warnings. © 2000 - 2015 Jobson Medical Information LLC unless otherwise noted. All rights reserved. Source


DeRuiter J.,Auburn University | Holston P.L.,Health Information Designs
U.S. Pharmacist | Year: 2012

New molecular entities (NMEs), as defined by the FDA, are drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in 2011-2012 (TABLE 1) detail the basic clinical and pharmacologic profiles for each new drug, as well as its pharmacokinetics, adverse reactions, drug interactions, and dosing data. Note that the information for each NME was obtained primarily from sources published prior to FDA approval; thus, it is essential that practitioners become aware of changes in a drug's therapeutic profile as reported by their own patients and in the pharmaceutical literature, such as the emergence of additional adverse reactions and black box warnings. © 2000-2012 Jobson Medical Information LLC unless otherwise noted. Source


DeRuiter J.,Auburn University | Holston P.L.,Health Information Designs
U.S. Pharmacist | Year: 2012

New molecular entities (NMEs), as defined by the FDA, are drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in 2011-2012 (TABLE 1) detail the basic clinical and pharmacologic profiles for each new drug, as well as its pharmacokinetics, adverse reactions, drug interactions, and dosing data. Note that the information for each NME was obtained primarily from sources published prior to FDA approval; thus, it is essential that practitioners become aware of changes in a drug's therapeutic profile as reported by their own patients and in the pharmaceutical literature, such as the emergence of additional adverse reactions and black box warnings. © 2000-2012 Jobson Medical Information LLC unless otherwise noted. All rights reserved. Source


Deruiter J.,Auburn University | Holston P.L.,Health Information Designs | Deruiter T.J.,Auburn University
U.S. Pharmacist | Year: 2014

New molecular entities (NMEs), as defined by the FDA, are new drug products containing as their active ingredient a chemical substance marketed for the first time in the United States. The following descriptions of NMEs approved in 2013–2014 (TABLE 1) detail the basic clinical and pharmacologic profiles of each new drug, as well as key precautions and warnings. Also included is a brief summary of selected pharmacokinetic, adverse-reaction, drug-interaction, and dosing data submitted to the FDA in support of the manufacturer’s New Drug Application. The information for each NME was obtained primarily from sources published prior to FDA approval. Experience clearly demonstrates that many aspects of a new drug’s therapeutic profile are not detected in premarketing studies and emerge after the drug is used in large numbers of patients. For example, “new” adverse reactions for many NMEs often emerge within 2 to 3 years after they first become available. Some of these drugs may eventually acquire at least one black box warning for serious adverse drug reactions or are withdrawn from the market for safety reasons that were not recognized at the time of approval. Hence, while this review offers a starting point for learning about new drugs, it is essential that practitioners be aware of changes in a drug’s therapeutic profile as reported in the pharmaceutical literature and by their own patients. © 2000 - 2014 Jobson Medical Information LLC unless otherwise noted. All rights reserved. Source


Trademark
Health Information Designs | Date: 2009-04-23

Computer system consisting of computer hardware and analytical computer software that performs analysis of healthcare transactions or activities to detect suspicious or high risk activity indicating the potential presence of fraud or abuse by identifying abnormal patterns, profiles or transactions.

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