What is Six Sigma?

Six Sigma is a performance improve-ment methodology that seeks to identify the key sources of variation in a process(critical factors) that cause defects to occur. By mapping processes, measuring their output, and analyzing its many input variables, Six Sigma determines how to optimize the output from a process by controlling the inputs. Six Sigma projects move through a disciplined framework (known as 'DMAIC')

Define the problem – in terms of performance, consequences and gaps from what is desired 

Measure the process – first to ensure the data is reliable, then to decide how well the process performs 

Analyze the variables – using statistical tests of significance, to find those variables that have the greatest impact on process yield

Improve the process – through small scale experiments and hypothesis tests to compare the impact, before and after

Control the process – to sustain gains and ensure process does not regress to previous levels

Modified Release Drug Product

The term modified-release drug product is used to describe products that alter the timing and/or the rate of release of the drug substance. A modified-release dosage form is defined

as one for which the drug-release characteristics of time course and/or location are chosen to accomplish therapeutic or convenience objectives not offered by conventional dosage forms such as solutions, ointments, or promptly dissolving dosage forms as presently recognized.

Several types of modified-release drug products are recognized:


1. Extended-release drug products. A dosage form that allows at least a twofold reduction in dosage frequency as compared to that drug presented as an immediate-release (conventional) dosage form. Examples of extended-release dosage forms include controlled-release, sustained-release, and long-acting drug products.

How Are Drugs Designed?

Drug design is the process of finding new drugs based on the understanding of the disease and the structure and function of a biological target molecule involved in the disease. Once these are known, chemical compounds  are  synthesized  with  structures that allow them to bind to and alter the behavior of the target. The structures of  these  compounds  are  progressively refined,  often  using  computer-modeling, to fit even better with the target. In addition to being able to bind to the target, a drug must be able to pass through barriers our body puts in its path. It must be able to adequately withstand the body’s protective mechanisms that reject or decompose it. Ultimately, the body should be able to eliminate and remove the drug. This systematic approach to new drug discovery is called rational drug design.

In  the  past,  most  drugs  were  discovered through a search of natural sources such as plants and microorganisms, or by the synthesis of an extensive number of compounds of varying structures. These synthetic  or  natural  compounds  were then tested for various kinds of biological activities  in  the laboratory.  This  type  of trial-and-error  approach,  called random screening, resulted in the discovery and development  of  many  important  drugs. It still has a place in drug discovery and is  often  used  by pharmaceutical  companies  to  identify lead  compounds.  These lead  compounds  are  then  synthetically modified  to  give  new  compounds  with improved properties.

Most drugs are small organic molecules produced through chemical synthesis, but biopharmaceutical drugs (also known as biologics)  produced  through  biological processes are becoming increasingly more common. [Source: Introduction to Pharmaceutical Sciences]

Pharmaceutical Cartoon: Reason behind pharma pricing!