Solid Oral Delivery Systems | Agenda

DRAFT

Day 1

How do processes and systems improve quality?
  • Quality systems
  • FDA review and inspections
  • FDA guidance on Process Analytical Technology (PAT)
  • The role of polymorphs
Topics Presenters
Introduction & overview Dr. Ajaz Hussain, NIPTE
Course mission & the importance of Pharmacokinetics (PK) Dr. Kenneth Morris, Long Island University
Introduction to solid state chemistry Dr. Stephen Byrn, Purdue University
Preformulation & solid state chemistry Dr. Stephen Byrn, Purdue University
Dr. Kenneth Morris, Long Island University
Case Study: Selecting the Best Form for Development Dr. Stephen Byrn, Purdue University
Perspective on solid state chemistry Dr. Ziyang Su, FDA (invited)

Day 2

What is the impact of formulations and chemistry on quality medicines?
  • Formulations and formulation design practices
  • FDA review and inspections
  • Excipient chemistry
  • Design of Experiments and other approaches
Topics Presenters
Introduction to solid dosage forms and excipients Dr. Stephen Hoag, University of Maryland
Case study: Formulation Design Dr. Stephen Byrn, Purdue University
Dr. Stephen Hoag, University of Maryland
Measurement system suitability and capability in the context of process validation (FDA Guidance 2011) Dr. Alex Viehmann, FDA (invited)
Manufacturing of drug product Dr. Stephen Hoag, University of Maryland
Case study: Process Induced Stability Problems Dr. Stephen Byrn, Purdue University
Perspective on pharmaceutical manufacturing
and drug quality
FDA (invited)

Day 3

What role do testing and evaluation play in quality medicines?
  • Evaluation of pharmaceutical drug products
  • Dissolution testing — pros and cons
  • pharmacokinetics and how pharmacokinetic study procedures
  • Other properties tested to monitor quality
Topics Presenters
Introduction to dissolution and factors influencing dissolution Dr. James Polli, University of Maryland
Case study: Dissolution Design Dr. James Polli, University of Maryland
Dr. Kenneth Morris, Long Island University
Perspective on dissolution testing and drug quality Dr. Cindy Buhse, FDA (invited)
Drug product quality in the 21st century Dr. Ajaz S Hussain, NIPTE
Pharmacokinetics Dr. James Polli, University of Maryland
Perspective on pharmacokinetics Dr. Kimberly Raines, FDA (invited)