Featured Articles
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The Importance Of Strategic Alliance Partners
Complex drug delivery systems require teamwork between biopharmaceutical companies and their drug delivery technology partners to develop innovative platforms for patient use. These alliance partners must ensure self-administered therapies are safe, easy to use, and effective.
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FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III
The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.
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Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers
Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.
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Delivering Market Success For Pharma Partners From Concept To Patient
The development of drug delivery devices that are innovative, intuitive, patient friendly, and patient safe must address certain areas of concern that are particular to both biologic and biosimilar therapies.
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Benefits Of QbD: Considerations For Drug-Device Combination Products And Partnerships
Quality by Design (QbD) achieves quality through understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated.
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Functional Performance Of Stoppers To Support Multipuncture Use
Multi-dose vials enable dosing flexibility to a diverse group of patients with different dosages dependent on patient age/weight and can create efficiency and reduce packaging waste when vaccines are administered to large populations.
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Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?
Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.
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4031 Ready Methods Reduce E&L Timelines
An established approach for executing extractables and leachables evaluations for individual drug products comprises understanding risks, developing and validating targeted leachables studies, and supporting drug products through stability testing.
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Successful Industrialization Requires Solid Foundations
Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.
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Design Success Combined With Expertise In Testing And Raw Material Selection
Learn more about improvements and optimized benefits across the packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.