Pharmaceutical Dosage Forms - Introduction, Preparation, Product Quality Testing, Packaging and Storage, Basic Regulatory Requirements and Guidelines (Classroom)

Event

Course Description:
This course will cover the factors to be considered when choosing dosage forms, different types of dosage forms, and their preparation. It will also cover suitable product quality tests to ensure safety, efficacy, strength, quality, and purity. Dosage form stability, packaging, and storage will be explored through case studies, discussions, and assignments. Basic regulatory requirements and guidelines will also be discussed.

By taking this course, you will learn about:

  • Explain and understand types of pharmaceutical dosage forms and routes of administration
  • Understand basic principles of dosage form design
  • Select suitable methods for the preparation of pharmaceutical dosage forms
  • Design the protocol and perform pre-formulation studies
  • Explain the concept of bioavailability and correlate it to various dosage forms
  • Describe formulation techniques to enhance the solubility of poorly soluble drugs
  • Understand the rationale for product quality tests and various instruments used to test different dosage forms per USP GC <1151>
  • Explain the physicochemical properties of pharmaceutical dosage forms
  • Understand the concept of uniformity of dosage for tablets and other drug products
  • Identify the critical quality attributes of different dosage forms
  • Understand various regulatory requirements for packaging and labeling of different dosage forms

Who should participate:

  • Analytical Scientists
  • QA / QC analysts
  • R&D scientists and managers
  • RA specialists
  • CRO
  • CMO
  • Staff with more than six years of experience.