The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
- Spine Care Redefined: Autologous Cell Therapy For Degenerative Disc Disease
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- When Software Becomes Part Of The Medicine
- Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
- Treatment Adherence And Designing Therapeutics To Meet Patient Needs
- Complaints Into Practical Action: Human Factors Drug Delivery
- Human Factors: A Key Factor In Regulatory Approvals
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Streamlining Primary Container And Device Selection With Predictive Calculations
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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10 Ways To Align Your Medical Device With Human Factors Industry Best Practices
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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How To Achieve Precise And Flexible Dosing With Multiparticulates
For orally delivered medicines, developers often must balance a drug’s “curb appeal” — its specific delivery mechanism, taste, ease of administration, and convenience — with safety and efficacy.
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Recent Innovations And Enhancements To Pharmaceutical Spray Drying
Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.
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Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway
Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
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Leveraging Integration At Each Phase Of A Drug Delivery System Project
By forging deeper partnerships with customers, the full depth and breadth of our knowledge, experience and competencies can bring benefits at multiple levels. See how an integrated offering helps at each phase of a drug delivery system project.
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Formulation Development Strategy For Early Phase Human Studies
Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.
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Sterile Injectable Therapies: Revolutionizing Lifecycle Management
The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats.
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Solid Form Strategies For Increasing Oral Bioavailability
Optimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
DELIVERED BY DEGRAZIO
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6 Packaging And Delivery Challenges For Biologic Therapies
In this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.

