What's new, what's different

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Apart from the measures of central tendency, distribution, outliers, and the changing characteristics of data with time, an important characteristic of any data set is its variation or spread. In some data sets, the data values are concentrated closely near the mean; in others, the data values are more widely spread out from the mean.
The range, standard deviation, standard error, and variance are the different measures of variation.
Range: The range is the difference between its maximum and...

Effective communication among healthcare professionals during hand-off reporting is essential to delivering safe and continuous patient care. Common professional interactions include reports to healthcare team members, hand-off, and transfer reports. Nurses routinely report information to other healthcare team members and also urgently contact healthcare providers to report changes in patient status.
Standardized methods of communication have been developed to ensure that information is...

Unusual results are those that have a very low chance of occurring. Unusual results can be identified using probabilities and the range rule of thumb. In problems involving probability, unusual results can be observed in 2 instances – an unusually high number of successes or an unusually low number of successes.
According to the range rule of thumb, any value above or below two standard deviations, 2σ  from the mean, μ  is considered unusual.
Maximum unusual value = μ + 2σ
Minimum unusual value...

The substance of the universe—from a grain of sand to a star—is called matter. Scientists define matter as anything that occupies space and has mass. An object’s mass and its weight are related concepts, but not quite the same. An object’s mass is the amount of matter contained in the object and is the same whether that object is on Earth or in the zero-gravity environment of outer space. An object’s weight, on the other hand, is its mass as affected by the pull of gravity. Where gravity...

An experiment is a planned activity carried out under controlled conditions. The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory or independent variable. The affected variable is called the response or dependent variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The...