Passive BCI in operational environments: insights, recent advances, and future trends

P Arico, G Borghini, G Di Flumeri… - IEEE Transactions …, 2017 - ieeexplore.ieee.org
Goal: This minireview aims to highlight recent important aspects to consider and evaluate
when passive brain-computer interface (pBCI) systems would be developed and used in …

[HTML][HTML] Injectable combination product development: facilitating risk-based assessments for efficiency and patient centric outcomes

F DeGrazio, D Paskiet - Journal of Pharmaceutical Sciences, 2020 - Elsevier
Combination products (CPs), designated by the US Food and Drug Administration, continue
to be on the rise, from the innovation of novel medicines and greater demand for injectable …

Insights into human factor studies conducted for US FDA-approved biological combination products

R Patel, M Mehta, P Pipalava, M Dahiya… - Expert Opinion on …, 2019 - Taylor & Francis
Introduction: With increasing use of biological products and devices, importance of human
factor (HF) studies is increasing. The HF study ensures safe and effective use of the device …

Prefilled Syringe Injection Force Impact Assessment from Back Pressure: An Approach for Testing Syringe Injectability In Situ vs. In Vitro

C Megna, O Wells, D Bonanno, W Rasheed… - PDA Journal of …, 2023 - journal.pda.org
Prefilled syringes are commonly used combination products for parenteral drug and vaccine
administration. The characterization of these devices is through functionality testing, such as …

Factors that facilitate regulatory approval for drug-device combination products in the European Union and United States of America: a mixed method study of industry …

F Masterson - Therapeutic Innovation & Regulatory Science, 2018 - journals.sagepub.com
Background: The regulatory environment is one of the key factors in successfully bringing an
innovative medical product, like a drug-device combination product, to market. This paper …