TRANSDERMAL DRUG DELIVERY ARTICLES
Improving Execution Of Biological Evaluation Of Drug Delivery Devices
This article provides a framework to streamline the biological safety assessment process, reduce testing burdens, and improve patient safety for combination products.
TRANSDERMAL DRUG DELIVERY VIDEOS
Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.
In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.
What types of products in development may need to be assessed in accordance with the FDA’s URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, describes several common scenarios that illustrate when a URRA approach may or may not be needed.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.
TRANSDERMAL DRUG DELIVERY RESOURCES
-
![GettyImages-1448043410 3D printing]( "3D Screen Printing: Enabling A New Generation Of Complex Formulations")
Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.
-
![GettyImages-1346675538-lab-research-development-test tubes]( "Solubility With Lipid-Based Technologies For Oral & Injectable Formulations")
Innovative 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.
-
![GettyImages-533059254-mRNA_DNA_gene_therapy]( "Combining Gene Therapies, Carrier Systems, And Medical Devices")
Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.
-
![science drug development data iStock-1209661917]( "Is Your Combination Product Drug-Led Or Device-Led?")
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
-
![GettyImages-2098817477-vaccine-needle-syringe-gloved-hands-laboratory]( "How Dermal Delivery Platforms Are Transforming Tomorrows For Patients")
Skin delivery platforms expand therapies by boosting convenience, stability, and adherence. Integrated formulation, device, and manufacturing development is key to confidently scale.
-
![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
-
![GettyImages-839214700-topical_medicine_cream_ssd]( "Semi-Solid And Semi-Liquid Dosage Forms: What To Know")
Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider.
TRANSDERMAL DRUG DELIVERY SOLUTIONS
-
![drug-delivery-technologies-GettyImages-2230291097]( "Dermal Drug Delivery")
A look at emerging dermal and intradermal delivery options, from customizable patches to microneedle systems, with key factors that enhance usability, stability, and therapeutic performance.
-
![GettyImages-1585548490-modular-facility-laboratory-drug-development]( "From Discovery To Impact: New Approach Methodologies")
Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.
-
![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
-
![Kindeva1]( "Your Partner For The Science Of Skin")
We know what it takes to deliver drug products to and through the skin. Explore drug-in-adhesive patches, solid microneedles (sMTS), and hollow microneedles (hMTS).
-
![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
