Quality is of paramount importance in the pharmaceutical industry. Any deviation from quality standards can lead to serious consequences, including product recalls, regulatory action, and harm to patients. Corrective and Preventive Action (CAPA) is a term used in the industry to describe a systematic approach to identifying and addressing quality issues. In this article, we …
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The pharmaceutical industry is constantly working to develop new therapies and treatments to improve patient outcomes. Developing a new drug can take years and millions of dollars, and not all drugs make it through the approval process. However, for drugs that show significant promise, the FDA offers a designation called Breakthrough Therapy Designation (BPD), which …
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The pharmaceutical industry is one of the most regulated industries in the world, and for good reason. The safety and efficacy of pharmaceutical products are critical to public health, and any errors or deviations in the manufacturing process could have significant consequences. To ensure consistency and quality in pharmaceutical manufacturing, the industry relies on various …
In the field of healthcare, decision-making can be challenging and complex, especially when it comes to evaluating the cost-effectiveness of new medical treatments. One tool that has been developed to aid in such evaluations is the Quality-Adjusted Life Year, commonly known as QALY. QALY is a widely used metric that helps decision-makers to balance the …
In the pharmaceutical industry, ensuring the quality and consistency of drug products is critical to ensuring patient safety and efficacy. One important document that plays a vital role in maintaining quality control is the Batch Manufacturing Record (BMR). Let’s dive deeper into what the BMR is and its importance in the pharmaceutical manufacturing process. A …
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Health Economics and Outcomes Research (HEOR) is a field of study that focuses on evaluating the value of medical interventions, including pharmaceuticals, medical devices, and other healthcare technologies. It involves analyzing the clinical, economic, and humanistic outcomes of these interventions to determine their effectiveness and cost-effectiveness. HEOR studies typically involve collecting and analyzing a variety …
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