These supplemental texts describe in details medicines development in different therapeutic areas and medical indications. The texts cover background to the indication, key points on regulatory guidances, trial design, endpoints with current examples.

The first supplement, described below, is  

 

Medicines Development in Alzheimer´s Disease

 

This e-text is designed to provide a clear explanation of the basic facts on how new medicines for Alzheimer´s disease are tested.

The sections are as follows:

1.  Foreword 
2.  Introduction
3.  Brain Basics
4.  Pathophysiology
5.  Symptoms
6.  Diagnostic criteria and tests
7.  Current treatments
8.  Symptomatic vs disease modifying approaches
9.  RegulatoryGuidelines
10. Clinical Trial Design and Phases
11. Endpoints: clinical
12. Endpoints: biochemical
13. Endpoints:neuroimaging, other
14. Key trial methodology issues
15. Prevention studies
16. Combination studies


The e-text is useful to anyone needing a concise summary about  Alzheimer's disease medicines development methodology. Background information on the condition itself is included to the extent needed for understanding the development aspects. Finally a short chapter on the basics of brain function has also been included for those new to this area.