Analytics for Pharma and Biotech Traders. Better intelligence tools for regulatory,. Financial, and clinical trial catalysts. Discover Trading Opportunities at Every Stage of the Drug Development Pipeline. Streamline Your Research with Intuitive Analytics.
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FDA Tracker – Analytics for Pharma and Biotech Traders | fdatracker.com Reviews
https://fdatracker.com
Analytics for Pharma and Biotech Traders. Better intelligence tools for regulatory,. Financial, and clinical trial catalysts. Discover Trading Opportunities at Every Stage of the Drug Development Pipeline. Streamline Your Research with Intuitive Analytics.
fdatracker.com
Adcom Explorer – FDA Tracker
https://www.fdatracker.com/adcom-explorer
Analytics for Pharma and Biotech Traders. Profile and Predict FDA Advisory Committee Votes. Sign up or log in to access Adcom Explorer! Construct a draft meeting roster and examine detailed individual voting records since January 1, 2008. Votes are supported by links to meeting minutes and transcripts. Use our proprietary “influence measure” to weight each person’s predicted vote based on how often his votes have agreed with past panel decisions. Delve Into Past Meetings.
Trial Tracker – FDA Tracker
https://www.fdatracker.com/trial-tracker
Analytics for Pharma and Biotech Traders. Screen Companies with Upcoming Clinical Trial Catalysts. Sign up or log in to access Trial Tracker! Screen catalysts by stock symbol, market cap, disease, completion date, and phase. Interactive chart displays trial pipelines by company and phase. Show the number of trials by phase and company. Tally the conditions being targeted, overall and by company. Unlocks all of the selection criteria to help you screen the full range of clinical trial catalysts.
FDA Calendar – FDA Tracker
https://www.fdatracker.com/fda-calendar
Analytics for Pharma and Biotech Traders. This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. Sign up or log in to access our Enhanced FDA Calendar!
Burn Rate – FDA Tracker
https://www.fdatracker.com/burn-rate
Analytics for Pharma and Biotech Traders. Estimate Cash Runways and Predict Dilution Events. Sign up or log in to access Burn Rate! Screen companies based on market cap and working capital runway length. Determine if a company needs money to reach a clinical or regulatory milestone. View working capital and cash burn rates for all companies in the healthcare sector.
Patent Tracker – FDA Tracker
https://www.fdatracker.com/patent-tracker
Analytics for Pharma and Biotech Traders. Survey the U.S. Drug Patent Landscape. Sign up or log in to access Patent Tracker! Explore the FDA Orange Book. View all exclusivity expirations, patent expirations, and pediatric extensions with links to Drugs@FDA and Google Patents. Display a timeline of patent expiration dates by company, drug, disease, or mechanism of action. List all drugs that have gone generic for a given company, drug class, or disease area.
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On Biostatistics and Clinical Trials: August 2014
http://onbiostatistics.blogspot.com/2014_08_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Friday, August 29, 2014. Subgroup Analysis in Clinical Trials - Revisited. I had previously written an article about the sub-group analysis. EMA is again ahead of FDA in issuing its regulatory guidelines on this topic. Following an expert workshop on subgroup analysis. EMA issued its draft guideline titled “ Guideline on the investigation of subgroups in confirmatory clinical trials. Sometimes it is no...
On Biostatistics and Clinical Trials: September 2014
http://onbiostatistics.blogspot.com/2014_09_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Saturday, September 13, 2014. N of 1 Clinical Trial Design and its Use in Rare Disease Studies. In the beginning (February) of this year, I attended a workshop titled “Clinical Trial Design for Alpha-1 Deficiency: A Model for Rare Diseases”. During the meeting, the N of 1 design was mentioned as one of the study methods to address the challenges in clinical trials in rare disease areas. The order of ex...
On Biostatistics and Clinical Trials: July 2015
http://onbiostatistics.blogspot.com/2015_07_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Tuesday, July 28, 2015. Clinical Research Toolkit by NIH and NCI. NIH (National Institute of Health). Has been the force in conducting the landmark clinical trials and conducting the clinical trials in the disease areas that pharmaceutical companies are either not interested in or cannot afford to conduct the trials. NCI (National Cancer Institute). Various clinical research toolkits are available on N...
On Biostatistics and Clinical Trials: March 2015
http://onbiostatistics.blogspot.com/2015_03_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Monday, March 16, 2015. Commonly Used Clinical Trial Terms in English and Their Chinese Translations; List of Regulatory Guidance for Clinical Trials in China. Some of the translations are different between the mainland China and the Taiwan. 吸收、分布、代谢、清除. Area Under Curve (AUC). Candidate Product (Proposed Product). Company Core Data Sheet (CCDS). Common Technical Document (ICH-CTD). Free Survival ,DFS.
On Biostatistics and Clinical Trials: October 2014
http://onbiostatistics.blogspot.com/2014_10_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Saturday, October 18, 2014. The fixed margin method or the two confidence interval method for obtaining the non-inferiority margin. As indicated in FDA’s guidance " Non-Inferiority Clinical Trials. There are essentially two approaches to derive the non-inferiority margin:. Or the two confidence interval method). And the other called the synthesis method. 8220;in the fixed margin method, the margin M.
On Biostatistics and Clinical Trials: Sample Size and Power Calculation Using SAS Proc Power and twosamplesurvival Statement
http://onbiostatistics.blogspot.com/2015/06/sample-size-and-power-calculation-using.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Sunday, June 14, 2015. Sample Size and Power Calculation Using SAS Proc Power and twosamplesurvival Statement. For sample size and power calculations, several commercially available software can be used. The commonly used ones are. The syntax and descriptions for Twosamplesurvival statement. In PROC POWER can be found on SAS website. It can be used to calculate:. Notice that only one. By Bauer, Lavery,...
On Biostatistics and Clinical Trials: April 2015
http://onbiostatistics.blogspot.com/2015_04_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Sunday, April 19, 2015. Hockey stick effect, yo-yo effect, honeymoon effect, halo effect, Hawthorne effect, John Henry effect, and Pygmalion effect. In clinical trials, people need to pay attention to the various effects in designing the clinical trials. A while ago, I mentioned the. Other these kinds of effects were described below. In a FDA ADCOM meeting minutes. Honeymoon effect is used to describe ...
On Biostatistics and Clinical Trials: Missing Data Mechanisms/Assumptions and the Corresponding Imputation Methods
http://onbiostatistics.blogspot.com/2015/08/missing-data-assumptions-and.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Saturday, August 01, 2015. Missing Data Mechanisms/Assumptions and the Corresponding Imputation Methods. Missing data is one of the classical issues in clinical trials and biostatistics. Since the National Research Council's report on missing data. Missing Data Assumptions and the Corresponding Imputation Methods. Missing Complete at Random. Missing at Random – ignorability assumption. Not MCAR or MAR.
On Biostatistics and Clinical Trials: February 2015
http://onbiostatistics.blogspot.com/2015_02_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Saturday, February 14, 2015. Data Transport Across Different Platforms: Creating and Reading the SAS transport files (.xpt, .cpt, .dat). Since there are different computer platforms (Windows - PC, Unix,. I discussed that for FDA submission, the SAS transport file must be generated using xport engine (i.e, using PROC COPY). Creating .xpt file using PROC COPY. We can also use SAS data step to read the &#...
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Finance Director At My Side Blog
Finance Director At My Side Blog. Just another WordPress weblog. February 4th, 2013. Welcome to WordPress. This is your first post. Edit or delete it, then start blogging! Posted in Uncategorized 1 Comment. Finance Director At My Side Blog is proudly powered by WordPress.
FDA Tracker – Analytics for Pharma and Biotech Traders
Analytics for Pharma and Biotech Traders. Better intelligence tools for regulatory,. Financial, and clinical trial catalysts. Discover Trading Opportunities at Every Stage of the Drug Development Pipeline. Streamline Your Research with Intuitive Analytics.
Noblitt & Rueland Home Page: FDA & ISO Medical Device Consulting & Training
FDA and International Consulting and Training Services. Disneyland Resort Course Listings. So Cal - Tourist Info. July 9-13, 2018. Medical Device Training to be held at Disneyland Resort! Expert Consultants ready to assist with your compliance needs! Medical Device Regulatory Submissions cleared quickly! Over 25 years of hands-on experience allows us to help our clients navigate the regulatory and compliance issues faced on a daily basis as well as occasional unwanted surprises encountered. Will be taugh...
www.fdatraining.net
Noblitt & Rueland Home Page: FDA & ISO Medical Device Consulting & Training
FDA and International Consulting and Training Services. Disneyland Resort Course Listings. So Cal - Tourist Info. July 9-13, 2018. Medical Device Training to be held at Disneyland Resort! Expert Consultants ready to assist with your compliance needs! Medical Device Regulatory Submissions cleared quickly! Over 25 years of hands-on experience allows us to help our clients navigate the regulatory and compliance issues faced on a daily basis as well as occasional unwanted surprises encountered. Will be taugh...
FDA Transparency Blog
FDA Basics Webinar December 11th: 20 Years Later Returning to FDA to Regulate Tobacco. September 17, 2013. You may know that Mitch Zeller became the Center for Tobacco Products’ (CTP) Director in March 2013. What you may not know is that he has been working on FDA issues for 30 years! Consider this your invitation to learn even more about CTP’s new director, via a special FDA Basics webinar. On December 11, 2013. The FDA’s Center for Tobacco Products will host the webinar. Turn up your speakers for audio.
fdatransparencyblog.wordpress.com
FDA Transparency Blog
FDA Basics Webinar December 11th: 20 Years Later Returning to FDA to Regulate Tobacco. September 17, 2013. You may know that Mitch Zeller became the Center for Tobacco Products’ (CTP) Director in March 2013. What you may not know is that he has been working on FDA issues for 30 years! Consider this your invitation to learn even more about CTP’s new director, via a special FDA Basics webinar. On December 11, 2013. The FDA’s Center for Tobacco Products will host the webinar. Turn up your speakers for audio.
