The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.
- Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms
- A Promising Approach To Develop An Inhalable, Temperature-Stable COVID-19 Vaccine
- Understanding The New MHRA Requirements For Medical Devices In Great Britain
- A Holistic Approach To Your Medical Device’s Usability
- Breaking Through The Blood–Brain Barrier: The Rise Of Focused Ultrasound
- A Cost-Effective Approach To EU MDR Compliance
- Eying Up The Era Of Topical Biologics
- Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification
ON-DEMAND WEBINARS
Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit.
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
Learn about key product parameters affecting patient acceptability and therapy adherence and taste masking strategies, including organoleptic and barrier coating approaches and microencapsulation technologies.
Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Patent Trolls]( "The Largest LOE Event In US Pharma History")
The Largest LOE Event In US Pharma HistoryAhead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.
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Wet Milling Vs. Dry Milling In The Pharmaceutical IndustryRead about the considerations necessary for choosing between wet milling and dry milling for a specific active pharmaceutical ingredient.
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A Smarter Strategy For Optimizing Oncology Drug ProductsJohn McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.
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Enabling Long Lasting Clinical Outcomes In Coronary StentingPolyester amides (PEAs) bring several desired and differentiating properties to drug-eluting stent (DES) applications for treating coronary artery disease (CAD).
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Four Challenges That Stall Advanced Therapy DevelopmentMany challenges can stall an advanced therapy’s development, the vast majority of them tied to inadequate preclinical planning and partner vetting.
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Rational Design Of Oral Nanosuspensions For Insoluble DrugsThe advantages of nanosuspension dosage forms include improving bioavailability and API stability, increasing drug loading, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.
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Sterile Injectable Therapies: Revolutionizing Lifecycle ManagementThe 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 Screening, Rapid Formulation Selection To Meet Tight TimelinesA comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.
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The Path To Self-Administration: Moving From PFS To Auto-InjectorReview advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.
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Solubility With Lipid-Based Technologies For Oral & Injectable FormulationsInnovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.
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In her new column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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Developers of combination products must address varied and numerous regulatory stipulations and considerations. In this article, drug delivery industry veteran Fran DeGrazio offers recommendations for how to do so efficiently and effectively.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
