Neura.net: Perspectives on CNS Disease Management
Member Login  |  Site Map  |  Disclaimer  |  Contact  |  Bookmark
Advanced Search
Text Size
 |  Sunday, September 05, 2010 
Home
 
 
Home > Neura > Biosimilar/Biogeneric Medications
Biosimilar/Biogeneric Medications
Download the Biosimilar/Biogeneric Medications (Vol. 10, Issue 1) Neura Issue
 

The current issue of Neura features an overview of biosimilar drugs, including specific details of pending legislation that will empower the FDA to review and approve these drugs. Other articles include a review of delayed-start clinical trial design and its uses in neurodegenerative research, a summary of ideas to help neurologists optimize office visits with their patients, and a Highlights section that summarizes several articles published recently in the literature.


    CME Biosimilar/Biogeneric Medications    PDF
Biologics are used heavily in the field of neurology, including most disease-modifying therapies for multiple sclerosis. Following the loss of patent protection for the earliest biologics, Congress has been tasked with passing legislation that will address the multiple concerns surrounding so-called “follow-on biologics” or “biosimilar drugs.” This article presents an overview of the challenges involved in duplicating biologics and introduces the major points of contention (semantic, biopharmaceutical, and legal) in the debate surrounding biosimilars.
 
   Delayed-Start Trials: Clinical Trial Design   PDF
In the absence of a biological marker, the FDA has suggested that a delayed-start trial (DST) is the type of clinical study most likely to satisfactorily demonstrate disease modification. In view of the important roles that DSTs will be playing in the evaluation of therapies for neurodegenerative diseases, an understanding of their design is essential. The methods used in DSTs and approaches to interpreting their results are reviewed in this article. In the next issue of Neura, the use of DSTs in the assessment of therapies for neurodegenerative diseases will be further explored by examining previous trials, with a glimpse into the future use of DSTs in neurologic research.
 
    Optimizing the Office Visit    PDF
In today’s healthcare climate, constraints on the amount of time available for office visits have placed demands on neurologists to increase their efficiency without compromising thoroughness. A variety of effective, practical, and simple strategies can aid the achievement of this goal. This article offers ideas to help neurologists optimize the office visit, from both the clinician’s and patient’s perspectives. Members of the Neura editorial board also lend their perspectives from practice on several topics addressed in the article.
 
    Highlights From the Literature    PDF
Highlights from recent articles include an update on oral therapies for MS, including 2 trials of fingolimod and 1 trial of cladribine, and a research article about the role of prion proteins in myelin maintenance.
 
   Patient Tear-Out: Optimizing Your Office Visit   PDF
Neura provides a number of tips to patients to help optimize their office visits to the neurologist. The article includes advice about writing lists of medications, which information/forms to bring to appointments, spending time to write down questions before each office visit, and bringing along a family member or caregiver.


   
        Add to Google Add to My Yahoo!
Neura.net is administered, managed, and populated by Expert Medical Education, a company dedicated to the education of healthcare professionals. The individual educational materials available here are supported by educational grants from Teva Neuroscience. This site is intended for U.S. audiences only. This Web site is for use by healthcare professionals only. It is not meant to serve as a substitute for a consultation with your physician. If you are a patient and would like to see Neura.net's educational material for patients, click here. Some discussions of drugs and devices contained on this Web site may include mention of uses that have not been evaluated by the United States Food and Drug Administration for safety and efficacy. Please consult complete prescribing information for any of the drugs and devices discussed before using them.
© 2010 Neura.net. All rights reserved.