Search Results for: COMBINATION PRODUCTS Human Factors Combination
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….
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.
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.
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.
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.
2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery June 29, 2021
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs June 2, 2021
Contributor Cindy Dubin highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices March 29, 2021
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.
SPECIAL FEATURE – Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis January 14, 2021
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.