200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

It is important for non-statisticians to become familiar with biostatistics

Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application […]

Statins ‘should be given to children with heart risks before the age of 10’

Statins should be given to thousands of children by the age of 10 under radical new NHS guidance. GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected. Estimates suggest up to 260,000 people – including 50,000 children – are […]

Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial. The results were part of a recent update that Vertex Pharmaceuticals provided on Orkambi and three of its other CF therapies, Kalydeco (ivacaftor), tezacaftor (VX-661) and VX-371. Vertex […]

The use of Applied Statistics for FDA Process Validation

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA […]

Medicaid platinum, silver for the rest

Insurance Commissioner Roger Sevigny … Findings of report are “not conclusive.” CONCORD — The path New Hampshire has taken toward expanding Medicaid is pushing prices up for everyone else who buys health insurance on the Obamacare exchange at healthcare.gov, according to an analysis recently completed for the Insurance Department. The average medical costs for the […]

Data visualization can have a great effect on statistical presentations

It is said that a picture is worth a thousand words. This adage may appear figurative and allegorical when applied to the realm of statistics, but there is no denying the fact that a visual approach to statistics enlivens the subject like no other. A dash of pictorial work and some coloring at the right […]

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

Understanding the practical application of statistics?

The application of statistical methods is specified all through 21 CFR and guidance documents

Article on “Statistical Sampling Plans for Medical Devices”

One of the important aspects of design control of medical devices is statistical sampling plans for medical devices. To gain an understanding of the idea of statistical sampling plans for medical devices, one needs to understand the process of medical device design controls. Statistical sampling plans for medical devices needs to be seen in this […]