A business case assessment for a novel mAb product identified for the treatment of severe asthma. Clinical Development and marketability.

Using the target product profile write the following strategies and justify the strategy adopted. Darren Wogman MSc

Clinical pharmacology support studies routinely required for IMP registration. SmPCs, ABA, FDI, ADME, QT, Renal, Hepatic, PopPK, DDI, BE

PK/PD Data Analysis - Macrolide Antibiotic. Original Dataset not included. Appendices not included.

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