Investigator Brochure. Delineate relevant details on Lipitor, its formulation and stability information and generate the CMC section
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Investigator Brochure. Delineate relevant details on Lipitor, its formulation and stability information and generate the CMC section of an IB. The template for the IB is provided below.
You need to generate a CMC section 3 in IB namely (template given below - end of this document):
3. Physical, Chemical and Pharmaceutical Properties and Formulation
3.1 Pharmaceutical Presentation
3.2 Physical and Chemical Properties of the Drug Substance
3.3 Formulation Including Excipients
3.4 Storage and Handling
You will have to provide the above CMC IB section for:
- The Drug/formulation information on Lipitor
- Create your own hypothetical parental formulation (propose your own excipients and storage conditions) for Lipitor
- Note: the active ingredient (drug substance) would stay the same. So some sections will be the same for all three formulations.
- Stick to a 3 page limit.
Related Book For
Fundamentals of Financial Accounting
ISBN: 978-0078025914
5th edition
Authors: Fred Phillips, Robert Libby, Patricia Libby
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