A business case assessment for a novel mAb product
A business case assessment for a novel mAb product identified for the treatment of severe asthma. Clinical Development and marketability.
Darren Wogman MSc
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Critique of Hamdy FC et al. N Engl J Med 2016; 375:1415-1424
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
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
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
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.
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
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
The pharmacological evidence required to justify clinical development of a drug candidate for depression | Darren Wogman