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To bring a new drug to market is a complex and highly regulated process.
Before a medicine becomes ready to use for the patients, it undergoes an extensive research, testing, and regulatory evaluation process.
This is to ensure the safety, efficacy, and quality of the drug.
In this context, one of the most important milestones in this journey is the New Drug Application (NDA) submission.
High cholesterol is one of the major risk factors contributing to heart attacks, strokes, and other cardiovascular complications. Hence, cardiovascular diseases remain the leading cause of death worldwide. Over the past four decades, statin drugs have become one of the most successful classes of medicines for reducing cholesterol levels and preventing cardiovascular disease.
This article explores statin drugs, their benefits, types, and real-world applications. Additionally, we will focus on the important role played by pharmaceutical impurity synthesis and reference standard manufacturers in supporting ongoing statin research.
In this blog we will learn about blood glucose regulators, also known as blood sugar regulators. In general, they are the chemical substances or hormones that are responsible for the maintenance of sugar levels in the blood.
Safe regulation of glucose/sugar in the blood is one of the most important biological processes in the human body. Every second, our body carefully balances blood sugar levels to provide energy to cells; at the same time, it protects the organs from damage caused by excessive glucose.
In the situation where this balance is disrupted, it can lead to serious health conditions such as diabetes, obesity, metabolic syndrome, cardiovascular disease, and nerve damage.
Thus, in these scenarios, blood glucose regulators become critically important.
In the pharmaceutical industry, a number of organizations work collaboratively in the search and development of safe medicines.
Large organizations work on the big picture to solve the problems; however, the smaller organizations work on technical precision and flexibility.
The small organizations play a crucial role in the pharmaceutical developments. They provide technical support in chemical synthesis and analytical method developments.
Specifically the small organisations are helpful for
Thus, the small organizations provide their indirect contributions to global healthcare innovations.
What are forced degradation studies?
Here in the following video a step-by-step explanation is given. This provides a brief overview of forced degradation studies, their impact, and their importance in the regulatory submissions of the drug products. This is helpful for the graduate students and industry professionals who want to pursue a career in the field of pharmaceuticals.
This video answers following questions:
What are API impurities?
What are the forced degradation studies?
What is the need for forced degradation studies for the new drug product?
What are the analytical tools required for these studies?
What is the impact of forced degradation studies?