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…
Chronic Heart Failure
Chronic Heart Failure Robert B. Parker, Jean M. Nappi, and Larisa H. Cavallari KEY CONCEPTS Heart failure (HF) is a progressive clinical syndrome that can result from any…
Osteoporosis and Other Metabolic Bone Diseases
Osteoporosis and Other Metabolic Bone Diseases Mary Beth O’Connell and Jill S. Borchert KEY CONCEPTS Osteoporosis is a public health epidemic that affects all ages, genders, races, and…
Cancer Treatment and Chemotherapy
KEY CONCEPTS Carcinogenesis is a multistep process that includes initiation, promotion, conversion, and progression. The growth of normal and cancerous cells is genetically controlled by the balance or imbalance…
Hypertension
Hypertension Joseph J. Saseen and Eric J. MacLaughlin KEY CONCEPTS The risk of cardiovascular (CV) morbidity and mortality is directly correlated with blood pressure (BP). Evidence from…
Acid-Base Disorders
Acid–Base Disorders John W. Devlin and Gary R. Matzke KEY CONCEPTS The kidney plays a central role in the regulation of acid–base homeostasis through the excretion or reabsorption…
