The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Ophthalmic Drug Delivery
Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.
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Spray Drying For Innovative Dry Powder Inhaler Combination Formulations
Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden and improving care. Explore case studies illustrating the potential for improving care for critically ill patients.
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Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization
Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
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4 Factors Affecting Solubility Of Drugs
Improper drug solubility can lead to suboptimal drug delivery and absorption, resulting in ineffective drug efficacy and side effects, so solubility must be evaluated in the early stages of drug discovery.
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Early Decisions To De-Risk The Transition To Combination Products
The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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Solutions For Challenging Compounds Using Softgel Innovation
The significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
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Overcoming Limitations To Achieve Uniform Dosing
An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.
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Engineering Advances In Needle Geometry To Accommodate Viscous Biologics
Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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Improved Bioavailability In 12 Weeks
A lead compound showed clinical promise but had limited bioavailability owing to low solubility. Learn about the challenges, including the molecular characterization and limited budget, and the structured 3-step approach.
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Design Verification Testing Of Combination Products
Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.
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FRANKLY FRAN
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The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.
- Preparing For The FDA QMSR: Will You Be Ready?
- Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
- Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
- Embrace Packaging and Delivery Systems Designed for Today's Standards
- The Key to Regulatory Innovation? Global Harmonization
- Organizational Imperatives For Combination Product Development