Introductory Course
The Gray Book e-text (formerly Gray´s Medicines Development) 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.
A key feature of the e-text is that it is hyperlinked to key regulatory guidelines. It is regularly updated. A Synopsis of the text is available in English, German, French, Japanese and Chinese.
- An Outline of the Development Process
- Discovery of New Medicines
- Development of Medicines: Planning
- Non-Clinical Safety Testing
- Pharmaceutical Development / Manufacturing
- Regulatory Issues Part 1 (Guidelines/IND/IMPD/Japan/Meetings
- Introduction to Clinical Research. Good Clinical Practice
- Statistics and Data Management
- Drug Safety, Pharmacovigilance and Pharmacoepidemiology
- Introduction to Pharmacokinetics, Population PK, Drug-Drug Interactions and Special Populations
- Phase I Studies
- Phase IIA Studies
- Phase IIB and Phase III Studies
- Regulatory Issues Part 2: Filing for Approval (NDA/MAA Filings)
- Pharmacoeconomics
- Patents
- Project Valuation
- Marketing, Information, Promotion and Education
Full lab to Market Case study
The Professional Version contains the GrayBook e-Text supplemented by a set of e-Tools and full example case study with document templates for drug developers.
The Gray Book e-text (formerly Gray´s Medicines Development) 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.
A key feature of the e-text is that it is hyperlinked to key regulatory guidelines. It is regularly updated. A Synopsis of the text is available in English, German, French, Japanese and Chinese.
- An Outline of the Development Process
- Discovery of New Medicines
- Development of Medicines: Planning
- Non-Clinical Safety Testing
- Pharmaceutical Development / Manufacturing
- Regulatory Issues Part 1 (Guidelines/IND/IMPD/Japan/Meetings
- Introduction to Clinical Research. Good Clinical Practice
- Statistics and Data Management
- Drug Safety, Pharmacovigilance and Pharmacoepidemiology
- Introduction to Pharmacokinetics, Population PK, Drug-Drug Interactions and Special Populations
- Phase I Studies
- Phase IIA Studies
- Phase IIB and Phase III Studies
- Regulatory Issues Part 2: Filing for Approval (NDA/MAA Filings)
- Pharmacoeconomics
- Patents
- Project Valuation
- Marketing, Information, Promotion and Education
A Case study with document templates and examples is included in the Professional version.
The electronic tools, currently in Excel spreadsheet format, include:
- 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