DEVICE REGULATIONS – The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome, and describes how the design and development of the BD Libertas(TM) is an attractive proposal for pharma companies.
Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
GLOBAL REPORT – 2017 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline
In the final installment of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, provides a pipeline review and analysis (centered on drug delivery and formulation products) looking forward and back 5 years for a total of 10 years.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability
Contributor Cindy H. Dubin highlights some of the key players in the market and where they are focusing their efforts to ensure products are of the highest quality, safe, and easy to use.
GLOBAL REPORT – 2017 Global Drug Delivery & Formulation Report: Part 3, Notable Transactions & Technologies of 2017
In part 3 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews transactions and technologies that provide greater insight into what we can expect in terms of product development and approvals over the next decade.
Theresa Bankston, PhD, says the fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with increasing complexity of longer-acting formulations, larger injection volumes, and longer injection durations, has raised the bar for seamless injection delivery technology.
CONTAINER CLOSURE SYSTEM – Recent Prefillable Syringe Developments Mirroring Increasing Biotech Drug Product Demands
Stefan Verheyden says the container closure system has become a decisive factor for sustained market success, with autoinjectors and injection pumps as growing areas of interest.
Degenhard Marx, PhD, and Günter Nadler discuss the treatment of sore throats via a pump spray and explore the considerations to be made when developing a reliable spray product.
EXCLUSIVE ONLINE CONTENT
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