DOSAGE CALCULATIONS
Dose = 1.75 mg/kg × 106.4 kg × 4 hours = 744.8 mg 5. 1250 mg/m2 po bid × 2 weeks, 1 week off then repeat for 3 cycles. BSA…
Pharmacovigilance Medical Writing for Marketed Products
5.1 Introduction Once a medicinal product has been approved for marketing, the marketing authorization holder (MAH) has an obligation to periodically submit a number of pharmacovigilance reports to relevant regulatory…
Pharmacovigilance Medical Writing for Marketing Authorization
3.1 Introduction The process of pre-authorization clinical development is considered complete when the sponsor has collated sufficient evidence of efficacy and safety for the investigated medicinal product. Thereafter, it is…
Pharmacovigilance Medical Writing in Risk Evaluation and Management
4.1 Introduction The pharmacovigilance documents associated with risk evaluation and management are often required components of Marketing Authorization Application (MAA) and New Drug Application (NDA) submissions, and thus could have…
The ad-hoc Safety Review and Response to Questions Document
6.1 Introduction In addition to the multiplicity of mandated periodic pharmacovigilance documents required for investigational and authorized medicinal products, documents submitted at the time of application for marketing authorization, and…
Pharmacovigilance Medical Writing for Clinical Trials
2.1 Introduction When a company or academic institution is granted permission to test a yet to be authorized medicinal product on human subjects (or an authorized medicinal product in a…
The Rest of the World
7.1 Introduction For obvious reasons, the main preoccupation of this volume has been to focus on pharmacovigilance medical writing as it is practiced in the EU and US. It would…
Pharmacovigilance Medical Writing – An Overview Across the Drug Development Process
In the first instance, the clinical development phase is associated with annual submissions of the Development Safety Update Report (DSUR) in the European Union (EU) and the Investigational New Drug…
Use of Vasopressors and Inotropes in the Pharmacotherapy of Shock
Use of Vasopressors and Inotropes in the Pharmacotherapy of Shock Robert Maclaren and Joseph F. Dasta KEY CONCEPTS Continuous hemodynamic monitoring with an arterial catheter or a central…
Colorectal Cancer
KEY CONCEPTS Advancing age, inherited and acquired genetic susceptibilities, lifestyle choices, inflammatory bowel disease, type 2 diabetes mellitus, and environmental factors are associated with colorectal cancer risk. Regular…
