| PEER-REVIEWED RESEARCH |
Robert Shaw and Marie South
The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
/ read more /
| MANUFACTURING |
Jennifer Markarian
Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes in R&D.
/ read more /
| QUALITY/REGULATIONS |
Feliza Mirasol
Tackling process development early on can better optimize manufacturing processes for emerging therapies.
/ read more /
| ANALYTICS |
Felicity Thomas
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
/ read more /
Felicity Thomas
Metrology has the potential to not only prevent harm to patients but also to support innovative therapeutic options.
/ read more /
| OUTSOURCING |
Rita Peters
Can investing in early development formulation studies drive new therapies successfully across the commercialization finish line?
/ read more /
| OPERATIONS |
Jennifer Markarian
Energy and water waste can be improved with new technologies, and sustainability can be considered in the design of new facilities.
/ read more /
| EDITOR'S COMMENT |
Felicity Thomas
Despite increasing R&D budgets by bio/pharma companies, returns on this investment are reducing and the cost of bringing an asset to market is increasing.
/ read more /
| EUROPEAN REGULATORY WATCH |
Sean Milmo
EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.
/ read more /
| ASK THE EXPERT |
Siegfried Schmitt
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements.
/ read more /
|
