[图书][B] Guidelines for stopping mass drug administration and verifying elimination of human onchocerciasis: criteria and procedures

World Health Organization - 2016 - apps.who.int
1 Executive Summary This document provides a summary of the evidence to support the task
of the WHO guideline panel in updating the guideline “Verification of elimination of human …

… and optimization of topical therapeutic products: sponsored by the American Association of Pharmaceutical Scientists (AAPS) and US Food and Drug Administration  …

VP Shah, CR Behl, GL Flynn, WI Higuchi… - International journal of …, 1992 - Elsevier
procedure runs the risk of extracting drug which otherwise would be retained in the skin layers.
A validated wash procedure needs to be developed for use in drugDrug Administration. …

[HTML][HTML] Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration

I Kirsch, BJ Deacon, TB Huedo-Medina… - PLoS …, 2008 - journals.plos.org
… We compared drug–placebo differences in improvement to criteria for clinical efficacy, and
we used meta-regression procedures [11] to identify the relation of severity to improvement. …

Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc …

D Murrey, M Janssen, R Delamarter, J Goldstein… - The Spine Journal, 2009 - Elsevier
… This was not surprising given the similarity in technique and treatment course between the
study and control procedures. In addition to success criteria required for FDA clearance, our …

Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final rule

Food and Drug Administration, HHS - Federal register, 2002 - pubmed.ncbi.nlm.nih.gov
… and Drug Administration (FDA) is issuing a final rule establishing additional criteria and
procedures by … may become eligible for consideration in the OTC drug monograph system. The …

A prospective, randomized, multicenter food and drug administration investigational device exemptions study of lumbar total disc replacement with the CHARITE™ …

S Blumenthal, PC McAfee, RD Guyer, SH Hochschuler… - 2005 - journals.lww.com
… One of the inclusion criteria for the study was a positive response to a provocative … undergo
a surgical procedure attributable solely to the results of the discogram. These criteria did in …

… analysis: Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the …

GA Shabir - Journal of chromatography A, 2003 - Elsevier
… with US Food and Drug Administration (FDA) regulations. For … necessary tests and acceptance
criteria for a given method. … procedure as will be used in the final method procedure (ie, …

… on Harmonisation; guidance on Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances …

Food and Drug Administration, HHS - Federal register, 2000 - pubmed.ncbi.nlm.nih.gov
… concerning the selection of test procedures and the setting and justification of acceptance
criteria for new chemical drug substances and new drug products produced from them. The …

… : an ad hoc task force report of the Patient‐Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001

C Acquadro, R Berzon, D Dubois, NK Leidy… - Value in …, 2003 - Wiley Online Library
… For PROs to be incorporated as evaluation criteria in the drug approval process and as … ,
the adjustment procedure for multiple testing, and a scientific procedure to handle missing data. …

[HTML][HTML] Criteria to stop mass drug administration for lymphatic filariasis have been achieved throughout Plateau and Nasarawa states, Nigeria

A Eigege, DS Evans, GS Noland, E Davies… - The American Journal …, 2017 - ncbi.nlm.nih.gov
… (TAS) to determine whether mass drug administration (MDA) for LF could … Annual mass drug
administration (MDA) at sufficient … Ten of the 30 LGAs met the criterion for stopping LF MDA (…