|
|
European Pharmaceutical Contractor
|
This article is not a step-by-step guide to the well-defined stages of clinical development, as there are plenty of excellent texts on the definitions of each phase and all the regulatory requirements and implications. However, it is useful to review the impact of the individuals involved in the team assembled to convert the project to a product.
So let's move beyond the mechanical activities to the thought processes at each stage, the considerations and implications of the decision-making at each step, and how these are communicated to everyone involved.
In an ideal world the end of Phase I is reached with all the preclinical data completed to add to the first human safety and tolerance data. The project is then clearly mapped out through the stages leading to marketing approval for the chosen indication(s), with all the timelines neatly illustrated by whatever project management software is used. And then reality kicks in...
|
Read full article from PDF >>
|
 |
 |
 |
Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | |
|
|
 |
News and Press Releases |
 |
WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec –
and Dizal Pharmaceutical, a biotechnology company, announce a strategic
partnership. Under the terms of the collaboration, WuXi STA will become
the preferred CDMO partner of Dizal Pharmaceutical for GMP production,
providing integrated CMC (Chemical, manufacturing and Control) process
research and manufacturing services from API to drug product.
More info >> |
|

 |
White Papers |
 |
|
 |
Industry Events |
 |
2020 Avoca Quality and Innovation Summit
3-4 June 2020, Amsterdam, The Netherlands
The 2020 Avoca Quality and Innovation Summit will take place 3-4 June
2020, in Amsterdam, The Netherlands.
More info >> |
|
|