All Blog Posts Tagged 'development' (24)

Lyophilization is the clinical term for freeze-drying. In the simplest terms, it can be described as a technical process in which the moisture level of many materials is reduced, most times frozen, for the purpose of creating a new product or an ingredient.

When an injectable drug is freeze-dried -this is the process of lyophilization -its compounds are stabilized. This reconstitution process is…

Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.

Some of the major differences between device and drug clinical research include:

Requirement for a study:

One of the important differences between device and…

The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.

The aim of doing so is to substantiate the suitability of…

The basic reason for which analytical methods and procedures need to be validated is to ensure that analytical data have consistency, accuracy and reliability. This becomes possible when laboratories employ proper scientific methods and procedures and validate analytical methods and procedures. This is the only means to ensure that the analytical data are reliable, consistent and accurate.

The aim of doing so is to substantiate the suitability of…

A perfect hire is a boon to any organization. At the other extreme, a bad hire can bring the inverse result to the organization: It can not only impede productivity; it can even result in drawing the organization into legal issues associated with wrong hiring. Problem employees create employee problems, which is why HR professionals need to be aware of what steps to take and what scenarios to avoid if…

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH…

The constant pressure on health services is an age old cliche, we need to constantly look at ways of improving the method of delivery with the growing demand of patients. We believe that everyone in the world should have access to safe, fast, affordable healthcare. Yet our healthcare services are falling short. Technology that connects patients with high quality care is part of the solution and we think we’re uniquely positioned to build it.

This correlates with the latest…