Regulatory Strategy for Novel Vaccine
Develop a regulatory strategy for this novel vaccine[..[Critically discuss the potential regulatory incentives as well as obligations
Feedback for 'Three core components of the EU drug safety system'
Explain and critically evaluate how the three core components of the EU drug safety system operate
Only clinical research that is ethical is acceptable to support medical marketing . How do we know that clinical research is ethical?
A business case assessment for a novel mAb product identified for the treatment of severe asthma. Clinical Development and marketability.
What are the differences between embryonic stem cells and tissue stems cells? Discuss the efficacy and safety. Darren Wogman MSc
Critique of Hamdy FC et al. 10-year outcomes after monitoring, surgery or radiotherapy for localised prostate cancer. N Engl J Med 2016; 375
Clinical Trial Dataset Analysis - A phase 2a efficacy, safety and tolerability study on treating patients with schizophrenia
Using the target product profile write the following strategies and justify the strategy adopted. Darren Wogman MSc
A target product profile (TPP) for ATL-104. Use in Oral Mucositis (OM). Darren Wogman MSc
Clinical pharmacology support studies routinely required for IMP registration. SmPCs, ABA, FDI, ADME, QT, Renal, Hepatic, PopPK, DDI, BE
The pharmacological evidence required to justify clinical development of a drug candidate for depression | Darren Wogman
Novel Drug Formulation for a combination antihypertensive in those with swallowing difficulties. ACEI 20mg + Thiazide diuretic 25mg
Research piece written by Darren Wogman. The differences between pharmaceutical medicine, drug development and clinical development.