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{{Infobox drug}} articles that have Physiological parameters input: <!-- Physiology --> | source_tissues = | target_tissues = | receptors = | agonists = | antagonists = | precursor = | biosynthesis = Note: |metabolism= will only show in the Physiologic data section when other input is present. Same for metabolism input under the pharmacokinetic ...
Physiological Reviews is a journal published quarterly by the American Physiological Society which has been published since 1921. [1]: 75 [2] [3] The editor in chief of the journal is Sadis Matalon (University of Alabama at Birmingham). [4] [5] The journal's first managing editor, who served to his death in 1946, was Dr. Donald R. Hooker.
Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. [1] RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). [2]
The 2018 issue has a list of about 180 such databases and updates to previously described databases. [2] Omics Discovery Index can be used to browse and search several biological databases. Furthermore, the NIAID Data Ecosystem Discovery Portal developed by the National Institute of Allergy and Infectious Diseases (NIAID) enables searching ...
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
The EUND pathway was developed to allow a mechanism for authorization of these drugs based on non-clinical and limited clinical information. A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1): [2] (a) the new drug is intended for
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New Drug Application – a submission to the FDA by a pharmaceutical company for review and approval of a new drug Abbreviated New Drug Application – a submission to the FDA review and approval of a generic drug; FDA Fast Track Development Program – a designation given to an NDA by the FDA that accelerates review and approval of new drugs