Drug Development White Papers & Articles
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Making The Right Decisions Upstream To Ensure Downstream Success
5/12/2022
Explore the latest strategies and technologies to develop a comprehensive, optimal approach to assay development and product characterization.
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Liposomal And Nanoparticle Technology
4/20/2022
Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
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Accelerating The Development Of Orphan Drugs For Rare Diseases
4/18/2022
Explore four principal CMC challenges for the developers of orphan drugs and the potential emerging solutions.
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Single-Use Solutions For Research And Process Development
4/12/2022
Can supply chain assurance be maintained while offering an array of possibilities to achieve complex process designs? Learn if you could benefit from a modularized, standardized single-use manifold design.
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Outsourcing Process Development: Key Considerations For Biopharma
3/14/2022
In Best Practices for Outsourcing Process Development, a panel of experts discussed four themes that may help drive the best outcomes when vetting process development service providers.
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Accelerating The Development Of Oncology Medicines
3/3/2022
Oncology drug development has seen a significant shift in focus, as molecule chemistries and drug technologies have improved. Explore five areas for consideration and the potential emerging solutions.
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Assessing A Platform for Accelerating Product Development
3/3/2022
Examine an innovative approach to accelerating drug development, and learn the savings to drug developers from applying the approach across the industry portfolio of investigational drugs.
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Strategies For Accelerating The Development Of Modified Release Oral Forms
3/3/2022
Careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.
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Developmental Testing Of IV Solutions
2/10/2022
As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.
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ICH And USP <1220>: Implementing A Quality By Design Analytical Framework
2/9/2022
The ICH and the USP are currently finalizing draft guidelines that describe a new paradigm for analytical development based on the QbD approach used for development.