Noble Launches Human Factors Engineering Services to Support Product Development and US FDA Approval of Medical Devices & Combination Products February 4, 2021

Noble, an Aptar Pharma company and world leader in providing drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, recently announced the launch of Human Factors Plus (HF+), an expanded service to further….

COMBINATION PRODUCTS - Human Factors & Combination Products March 2, 2015

Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.

DEVICE DEVELOPMENT - How to Ensure pMDI Drug Products Are Fit for the Future Market Landscape June 5, 2023

Ross Errington explores the latest developments in the pMDI segment and explains the steps pharmaceutical companies need to take to ensure their pMDI drug products are ready to thrive in a very different market environment.

MEDICAL DEVICE UX DESIGN - Bridging the Divide Between People & Products: How UX Design Can Improve Medical Device Product Development May 2, 2022

Aditya Jagannathan explains how human factors and industrial design can bridge the divide between people and products to maximize the likelihood that new medical devices will be safe and effective for the intended uses, users, and use environments.

INHALATION THERAPY - An Overview to Drug-Nebulizer Combination Development With Biologics November 30, 2021

Hernan Cuevas Brun, MBA, says biologic drugs are increasingly being investigated for delivery with inhalation therapy, which has initiated more in-depth discussions about the implications of formulation development and their pairing with adequate inhaled devices for more efficient treatment outcomes.

Noble Further Expands Capabilities of Its New Human Factors + Program June 9, 2021

In direct response to the rapid growth of the recently launched Human Factors + (HF+) program, Noble, an Aptar Pharma company, recently announced the….

COMBINATION PRODUCTS - Development Challenges & Solutions August 31, 2020

Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.

COMBINATION PRODUCT DEVELOPMENT - New Horizons in Development to Meet Emerging Demands October 1, 2019

Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.

MULTIPARTICULATE FORMULATIONS - Using Multiparticulate Technology to Develop Pediatric Drug Products February 28, 2019

Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.

INTEGRATED DELIVERY SYSTEMS - The Value of an Integrated System for Combination Products May 31, 2018

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.

ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products April 3, 2018

Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.

COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products January 13, 2017

Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.

COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products October 4, 2016

Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.

DRUG DEVICE MARKET - Joining Forces: Global Markets for Drug-Device Combinations November 19, 2015

Kevin James and Kevin Gainer of BCC Research indicate the development of the market for combination products is closely related to the drug delivery systems sector, which represents a vast area of research and the demand for sophisticated drug delivery devices behind many novel product developments.

SYRINGE SYSTEM - The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies October 5, 2015

John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.

EXCIPIENT UPDATE - Maximizing the Stability of Therapeutic Proteins Using Recombinant Human Albumin October 1, 2013

Mark Perkins, PhD, reviews some of the important factors involved, and highlights the advantages of including recombinant human albumin to stabilize protein therapeutics with reference to a recent case study.

SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024

Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.

SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest February 29, 2024

Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.

SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance September 5, 2023

Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.

PLATFORM DEVICE - Alina: Shining the “Light” on the Benefits of a Platform Approach to Treating Chronic Conditions June 5, 2023

Adam Stops, PhD, says the key to the success of any drug delivery device are factors such as proven technology, low development costs, fast time-to-market, and a strong intellectual property (IP) position for the pharma company, and against this background, platform drug delivery devices have become more important than ever.

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