References

Drug Discovery

• • The journey of a medicine from lab to shelf
  • Why are drugs so expensive?
  • 10-step life cycle management for medicines
  • Edwards, L., Fox, A., & Stonier, P. (Eds.). (2010). Principles and Practice of Pharmaceutical Medicine (3rd ed.). Oxford: Wiley-Blackwell. doi: 10.1002/9781444325263
  • van Nooten, F., Holmstrom, S., Green, J., Wiklund, I., Odeyemi, I.A.O., & Wilcox T. K. (2012). Health economics and outcomes research within drug development: Challenges and opportunities for reimbursement and market access within biopharma research. Drug Discovery Today, 17(11/12), 615-622. doi: 10.1016/j.drudis.2012.01.021

Australia Clinical Trial Notification

• • How medicines are approved for use in Australia
  • Australian Department of Health, Therapeutic Goods Administration
    • Who we are and what we do
    • TGA basics
    • TGA regulatory framework
    • Advisory Committee on Medicines (ACM)
    • ACM meeting statements
    • Prescription medicines registration process
    • Australian Public Assessment Reports for prescription medicines (AusPARs)
  • Australian Health Practitioner Regulation Agency
  • Guide to Accessing Medicines in Australia

Clinical Trial Phases I-III

• • Phase I and first-in-human Clinical Trials and FDA’s CGMP Requirements
  • What are the Clinical Trial Phases?
  • Clinical trial phases
  • Optimal Two-Stage Designs for Phase II Clinical Trials
  • Phase II Clinical Trial Design
  • Step 3: Clinical Research
  • What happens in phase III

Australia TGA/PBAC Approval

• • About the PBS
  • Purpose
  • Pharmaceutical Benefits Advisory Committee (PBAC) Membership
  • TGA and PBAC Parallel Process and Requirements
  • Procedures for consideration of submissions
  • Management of parallel process submissions
  • What is Medicare?
  • Enrolling in Medicare
  • What the TGA regulates
  • Australia – Pharmaceutical Global Health Technology Assessment Road Map

Phase IV Clinical Trials

• • Phases of a Clinical Trial
  • Phases of clinical trials
  • What Are the Phases of Clinical Trials?
  • Zhang, X., Zhang, Y., Ye, X., Guo, X., Zhang, T., & He, J. (2016). Overview of phase IV clinical trials for postmarket drug safety surveillance: A status report from the ClinicalTrials.gov registry. BMJ Open, 6(11), e010643. doi: 10.1136/bmjopen-2015-010643
  • Gale, E. (2012). Post-marketing studies of new insulins: sales or science? BMJ, 344, e3974. doi: 10.1136/bmj.e3974
  • Suvarna, V. (2010). Phase IV of drug development. Perspectives in Clinical Research, 1(2), 57–60. PMID: 21829783

Other

• • FDA drug development approval process
  • FDA drug and device approvals
  • FDA investigational drugs
  • UK authorisation for clinical-trials-for-medicines
  • Clinical research regulations, global comparisons