Posts

Showing posts with the label Regulatory Affairs

Transforming Drug Discovery with AI: Navigating Regulatory Guidelines

Image
Evolution of AI in Drug Discovery Artificial Intelligence (AI) is catalyzing a transformation in drug discovery and development. It offers innovative solutions that expedite processes and enhance efficiency. However, the adoption of AI in this critical sector also necessitates adherence to stringent regulatory guidelines set forth by bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In this article, we explore the pivotal role of regulatory bodies in guiding AI integration in the pharmaceutical industry while delving into some AI tools used in drug development and discovery. AI in Drug Discovery: A Regulatory Perspective Data Integrity and Quality Assurance : Regulatory agencies emphasize the importance of accurate, high-quality data in AI-driven drug discovery. AI tools like AtomNet specialize in small molecule drug discovery by utilizing deep learning-driven approaches. Ensuring data integrity is a priority, and FDA and EMA provide guid...

Navigating the Investigational New Drug Application (IND) Process: A Comprehensive Guide

Image
What is IND Application? An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. It describes  the purpose and overall clinical development plan for the drug or biological product The term also includes biological products that are used in vitro for diagnostic purposes. An IND application is a request for authorization from the FDA to administer an investigational drug or biological product to humans.     Contents of IND application: An IND application form (FDA Form 1571) and statement of investigator (FDA Form 1572),  specify following Contents: CMC information:  Chemistry, manufacturing, and quality control for the active moiety of the drug — for a biological product, this information includes the physicochemical characteristics, such as structure (if known), identity, purity, potency, and stability; a description of drug c...

Top 5 alternative careers for pharmacists

Image
The pharmacy degree is a science degree. Achieving a Masters in Pharmacy is a major achievement. There are many skills and a valuable resource of knowledge that pharmacists have gained over their many years of study and training which can be put to excellent use in other areas of work. Here are five career areas/areas of work, but the list isn’t exhaustive a nd many of you will have other suggestions. 1. Academia Many pharmacists go on to become lecturers in universities. Having experience of studying pharmacy, working within pharmacy or science or gaining real life work experience are major lifelines in delivering a strong quality of teaching and ensuring vital support to pharmacy students. It’s also very rewarding being able to share your experiences and knowledge with your audience in the lecture theatre. Pharmacists with strong public speaking skills will also find lecturing a great way to put their communication skills to good use. There are also many more opportunities...