Perspectives on the Translational Aspects of Articular Cartilage Biology
Kyriacos A. Athanasiou, Eric M. Darling, Grayson D. DuRaine, Jerry C. Hu, A. Hari Reddi in Articular Cartilage, 2017
Approval by the CDRH depends on the device’s class (Figure 6.12). Class I devices are low risk and pose minimal potential harm. The key regulatory compliance for a Class I device is that a company must demonstrate that it has implemented “general controls.” General controls include quality system regulation, as described by 21 CFR 820 (FDA 2011d), to ensure adherence to predefined design controls and cGMP; label requirements to prevent product mislabeling; and the use of Medical Device Reporting (MDR), as the mechanism to maintain records for the reporting of adverse events identified by the user, manufacturer, or distributer of the device. Handheld instruments, elastic bandages, exam gloves, and enema kits are examples of Class I devices. As part of the pathway to market, medical devices must use forms FDA-2891 and FDA-2892 for establishment, registration, and medical device listing.
Matched Data
Peter Cummings in Analysis of Incidence Rates, 2019
In a crossover study of two (or more) treatments, each subject receives both treatments and their outcomes under the two treatments are compared (Hills and Armitage 1979, Senn 2002, Jones and Kenward 2003, Mills et al. 2009). If treatment order is randomized, this is a type of randomized controlled trial. The design controls for confounding by any factor which is invariant within a person; genetic make-up, for example. A factor that changes over time, from the first treatment to the second, can be a potential confounder, although randomizing the order of the treatments may control for some of these factors. In these studies there is often concern about carryover bias (Cummings 2010), worry that the effect of the first treatment may persist long enough to influence the results of the second treatment. This is a matched design trial, in which each person given a treatment is matched to themselves when not given the treatment (or a different treatment) at another time.
Drug Monitoring: Modern Approaches to Quality Assurance
Steven H. Y. Wong, Iraving Sunshine in Handbook of Analytical Therapeutic Drug Monitoring and Toxicology, 2017
The introduction of the FDA’s revised GMP states that it is based on the principles of QA. The first principle states that safety and effectiveness must be addressed at the initial design stage and built into the finished product. Compliance with GMP will help ensure that quality is built in the device, because this relates to the design and validation of the process. The major change to the GMP is addition of design controls to help ensure that safety and effectiveness criteria are met. The second principle of the GMP is based on process validation and process control, because it is difficult and costly to inspect and test quality periodically in the finished product. The third principle is the adoption of rigid manufacturing controls to increase the probability that the finished product will meet specifications. By revising GMP and adopting the quality system approach, one can increase the scope to include design and produce a quality system that, if manufacturer’s conform to it, will result in a safe and effective device.
Experimental Research Methodologies in Organizational Behavior Management
Published in Journal of Organizational Behavior Management, 2021
Tyler G. Erath, Azure J. Pellegrino, Florence D. DiGennaro Reed, Sandra A. Ruby, Abigail L. Blackman, Matthew D. Novak
Experimental design is critical to making accurate inferences about the relation between events, as scientific knowledge is only as valid as its procedures. Internal validity refers to the extent to which the independent variable is responsible for the change in the dependent variable (Campbell & Stanley, 1963; Kazdin, 2011). As a continuum, internal validity is related to the degree to which an experimental design controls for extraneous variables or threats, such as history, maturation, selection biases, and others. The type of experimental design employed is a critical feature in determining the degree to which different threats are controlled (for a more detailed review regarding between-subject designs, see Campbell & Stanley, 1963; Shadish, Cook, & Campbell, 2002; for a more detailed review regarding single-case designs, see Kazdin, 2011). External validity refers to the extent to which findings are generalizable to different populations, times, and environmental settings (Baron & Perone, 1998; Zedeck, 2014). Internal validity is necessary (though not sufficient) for external validity; thus, to make inferences about the generality of the findings, there must first be a causal relation between events (Perone & Hursh, 2013).
Current trends in PLGA based long-acting injectable products: The industry perspective
Published in Expert Opinion on Drug Delivery, 2022
Omkara Swami Muddineti, Abdelwahab Omri
Further, an important area of development of PLGA based LAI is focusing research on drug–device combination products such as syringes, auto-injectors, dual-chamber pens. This technology helps in reducing the complexity of dose preparation and administration and finally increases self-administration for patients. But, device design, performance testing, design controls, and human factors evaluations need specialized skills, and massive investment in manufacturing is required for tooling, filling, and assembly of the combination products. Consequently, generic competitors must pursue partnerships with design firms, suppliers, or contract manufacturers to successfully establish the field.
Biosynthetic alternatives for corneal transplant surgery
Published in Expert Review of Ophthalmology, 2020
May Griffith, Bijay Kumar Poudel, Kamal Malhotra, Naoufal Akla, Miguel González-Andrades, David Courtman, Victor Hu, Emilio I. Alarcon
Production of implants for clinical trials is heavily dependent upon the implant classification, whether it is a medical device, a biologic, or a medicinal product. This is briefly discussed in Section 6.2, and standards that need to be followed are in Section 6.3. A key component in device manufacturing is the early establishment of design controls and maintenance of these records throughout the development process. It is appreciated that even during the early clinical feasibility trials where the device may be modified to accommodate user preferences or clinical needs, nevertheless, appropriate verification and validation must be performed and documented during this process.
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