Supplementary e-Text: Medicines Development in Alzheimer´s disease

The Graybook supplementary e-text on Medicines Development in Alzheimer´´s disease is designed to provide a clear explanation of the basic facts how new medicines are tested in this field.

The sections (or chapters) 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. Regulatory Guidelines
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
17. Appendix

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

The supplement is available at a small additional cost to licensees of the Gray Book Student or Professional version

The Gray Book  Student and Professional Versions

The Gray Book e-text covers all aspects of development from preclinical through clinical development to marketing. There are 18 sections, each covering one major area as shown below. An additional short section describes a "perfect case" to illustrate the overall process.
1. AN OUTLINE OF THE DEVELOPMENT PROCESS
2. DISCOVERY OF NEW MEDICINES
3. DEVELOPMENT OF MEDICINES: PLANNING
4. NON-CLINICAL SAFETY TESTING
5. PHARMACEUTICAL DEVELOPMENT/MANUFACTURING
6. REGULATORY ISSUES part 1(GUIDELINES/IND/IMPD/JAPAN/MEETINGS)
7. INTRODUCTION TO CLINICAL RESEARCH, GOOD CLINICAL PRACTICE
8. STATISTICS AND DATA MANAGEMENT
9. DRUG SAFETY, PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
10. INTRODUCTION TO PHARMACOKINETICS, POPULATION PK, DRUG-DRUG INTERACTIONS AND SPECIAL POPULATIONS
11. PHASE I STUDIES
12. PHASE IIA STUDIES
13. PHASE IIB and PHASE III STUDIES
14. REGULATORY ISSUES Part 2: Filing for approval (MAA/NDA Filings)
15. PHARMACOECONOMICS
16. PATENTS
17. PROJECT VALUATION
18. MARKETING, INFORMATION, PROMOTION AND EDUCATION
The core e-text is hyperlinked to key regulatory guidelines. It is regularly updated.
A Synopsis of the text is available in English, German, French, Japanese and Chinese
The Toolbox, available with the Professional Version, contains Excel based and document tools and templates to assist in the key activities in development . Spreadsheet application tools are provided to assist with the following activities:
-Target product profile, target label and core profile development
- Issue identification and management
- Key activity and action plan documentation
- Cost planning
- Development scenario building
- Go/no-go decision tracking
- Competitor documentation
- Sales forecasting
- NPV calculation
- Project upside identification
- Recruitment tracking


e-Courses


The introductory course, available to licensees of the Gray Book Student and Professional Versions, using the e-text supplemented with slides, self-assessment questions and case studies are available (see courses and contact admin@graybook.net).

The unique idea to market case, available to licensees of the Gray Book Professional Version, uses the e-text and e-tools including cost spreadsheets with Gantt charts to follow the development of a new medicine from concept and discovery to marketing
 

 

 

 

 

 

 

 

 

 

 

Updated version of GrayBook Supplement  Medicine´s Development in Alzheimer´s Disease available.