Assay sensitivity

Results: 32



#Item
21Medical statistics / Chemical pathology / Assay sensitivity / Pharmaceutical industry / Sensitivity and specificity / ELISA / Positive predictive value / Prevalence / Biomarker / Statistics / Immunologic tests / Biostatistics

Microsoft Word - Biomarker Qualification Stat Secondary Review2.doc

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Source URL: www.fda.gov

Language: English
22Biostatistics / Fungal diseases / Medical statistics / Categorical data / Positive predictive value / Sensitivity and specificity / Voriconazole / Aspergillosis / Assay sensitivity / Statistics / Medicine / Biology

Statistical Review and Evaluation

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Source URL: www.fda.gov

Language: English
23Medical statistics / Evaluation methods / Immunologic tests / Acronyms / Bioinformatics / ELISA / Clinical trial / Sensitivity and specificity / Test method / Statistics / Science / Measurement

Page 1 of 11 Appendix 3B. Review Memorandum Template and Instructions for Assay Only Submissions A. 510(k) Number: Indicate the 510(k) tracking number assigned to the document.

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Source URL: www.fda.gov

Language: English
24Obesity / Immunologic tests / Laboratory techniques / Ghrelin / Neuropeptides / ELISA / Biomarker / Assay / Chemistry / Medicine / Biology

Modification of Commercial Kit Assay Conditions May Be Necessary for Increasing the Sensitivity of Biomarker Quantification: A Case Study Matalin Shine, Deborah Martin and Masood Khan - KCAS, Shawnee, Kansas[removed]USA OB

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Source URL: www.kcasbio.com

Language: English - Date: 2013-05-28 13:26:20
25Molecular biology / Science / Polymerase chain reaction / Biotechnology / Hoffmann-La Roche / COLD-PCR / Biology / Chemistry / Laboratory techniques

Method S2. Assay evaluation on plasmids Mutant and wildtype plasmids were used in the preliminary selection of primer mixtures that provided the greatest sensitivity and specificity. The absolute mutation detection lim

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Source URL: stacks.cdc.gov

Language: English - Date: 2014-10-06 18:38:30
26Scientific method / Pharmacology / Design of experiments / Pharmaceutical industry / Evaluation methods / Assay sensitivity / Placebo-controlled study / Clinical trial / Placebo / Clinical research / Science / Research

Federal Register / Vol. 64, No[removed]Friday, September 24, [removed]Notices 49. Port Gamble S’Klallam Reservation in Kitsap County in Washington ($285,000)

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Source URL: www.fda.gov

Language: English - Date: 1999-09-24 01:39:00
27Design of experiments / Scientific method / Pharmacology / Pharmaceutical industry / Evaluation methods / Clinical trial / Assay sensitivity / Placebo-controlled study / Randomized controlled trial / Clinical research / Research / Science

E10: Choice of Control Groups and Related Issues in Clinical Trials

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Source URL: www.hc-sc.gc.ca

Language: English - Date: 2013-06-24 11:53:03
28Design of experiments / Scientific method / Pharmacology / Pharmaceutical industry / Evaluation methods / Clinical trial / Placebo-controlled study / Placebo / Assay sensitivity / Clinical research / Research / Science

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE

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Source URL: www.ich.org

Language: English - Date: 2012-06-22 05:13:58
29Biochemistry / Cyanide / Biomarker / Serum albumin / Albumin / Albumen / Human serum albumin / Blood proteins / Biology / Medicine

Cyanide Exposure Assay Background: A novel protein biomarker has been designed with improved sensitivity for detecting the presence of cyanide (CN) many days after exposure. Current testing methods measure CN in whole bl

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Source URL: www.healthresearch.org

Language: English - Date: 2012-04-02 10:30:19
30Research / Scientific method / Pharmacology / Pharmaceutical industry / Evaluation methods / Clinical trial / Placebo-controlled study / Assay sensitivity / Placebo / Clinical research / Science / Design of experiments

Guidance for Industry E 10 Choice of Control Group and Related Issues in Clinical Trials U.S. Department of Health and Human Services Food and Drug Administration

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Source URL: www.fda.gov

Language: English
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