In this course we will focus on how active compounds are developed into a formulation suitable for dosing in animal studies and early human clinical trials. Factors such as the route of administration, enhancing the solubility of the drug substance, the crystalline form of the drug substance, drug substance vs. drug product, storage requirements, and how special requirements of the patient population play a role in the design of an ideal formulation will be covered. Finally, some of the differences encountered when formulating a biologic vs. a small molecule will be discussed.
Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.
Welcome, by the end of the course students will be able to: Define the concepts of formulation, drug substance, and drug product. Describe the role of pre-formulation in drug discovery and its impact on route of administration selection. List and explain the importance of physicochemical properties in drug discovery and development. Compare and contrast the pre-formulation considerations for small molecule drugs and biologics.
Novartis is committed to empowering the next generation of healthcare leaders. These courses are designed to help learners contribute to healthcare research and community well-being.
When will I have access to the lectures and assignments?
To access the course materials, assignments and to earn a Certificate, you will need to purchase the Certificate experience when you enroll in a course. You can try a Free Trial instead, or apply for Financial Aid. The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
What will I get if I subscribe to this Specialization?
When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile.
Is financial aid available?
Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.