Introduction to the GaBI Journal
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 1
Abstract
I am proud and pleased to be able to write the introduction to this first issue of the Generics and Biosimilars Initiative Journal (GaBI Journal).
Authors and Affiliations
Philip D Walson
Health professionals in the risk communication process on counterfeit medicines
Communication is a key component in the fight against counterfeit medicines affecting the lives of patients. Two types of risk communication should be distinguished: pro-active and reactive. Reactive communication can be...
Maximizing quality in the manufacture of biologicals
Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks can be managed mo...
Biologicals and biosimilars: a review of the science and its implications
Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory requirements fo...
How matrix models can support generic medicine prescribing
This paper describes the design of currently available matrix models and assesses the experience with these models to date. Matrix models provide a valuable tool to facilitate transparent and interactive evidence-based m...
Why bioequivalence and unconditional interchangeability of generic drugs are not the same
The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and individual phys...