The Difference Between Verification and Validation of Analytical Methods in The Pharmaceutical Industry

To submit a dossier for marketing authorization to the Regulatory affairs, a product owner must provide Common Technical Documentation (CTD) containing a pharmaceutical product characteristics, manufacturing, quality control, safety (nonclinical), and efficacy (clinical) testing results before gaining approval for market access. Although quality improvement measures in the quality control laboratory have been enormous in recent years, especially due to improved handling of the validation and verification of the method performance, they often still differ widely from laboratory to laboratory. Much of what has been published on this topic is difficult to apply in routine laboratories due to complex statistics. The result is that method validation is often implemented incorrectly, which leads to false conclusions about the performance of the method, potentially compromising patient safety. The purpose of qualification, validation and verification is to generate reliable data for the products tested, resulting in the delivery of quality drug products to the patients. Therefore, the aim of this research is to emphasize the differences between verification and validation of analytical methods in the pharmaceutical industry

The difference between verification and validation of analytical methods in the pharmaceutical industry

To submit a dossier for marketing authorization to the Regulatory affairs, a product owner must provide Common Technical Documentation (CTD) containing a pharmaceutical product characteristics, manufacturing, quality control, safety (nonclinical), and efficacy (clinical) testing results before gaining approval for market access. Although quality improvement measures in the quality control laboratory have been enormous in recent years, especially due to improved handling of the validation and verification of the method performance, they often still differ widely from laboratory to laboratory. Much of what has been published on this topic is difficult to apply in routine laboratories due to complex statistics. The result is that method validation is often implemented incorrectly, which leads to false conclusions about the performance of the method, potentially compromising patient safety. The purpose of qualification, validation and verification is to generate reliable data for the products tested, resulting in the delivery of quality drug products to the patients. Therefore, the aim of this research is to emphasize the differences between verification and validation of analytical methods in the pharmaceutical industry

CAD/desing and types of aestethic layerng zirconia

Introduction: Zirconium restorations are put in place to achieve a better aesthetic appearance that over the years aesthetically does not satisfy or if there is a shortage of certain teeth to compensate for the space. Aim: To present the method of making full-featured zirconia and the construction of a vestibular cut-back modeling technique through a CAD / Design system with complete anatomy-morphological features. The aim is to make a comparison between these two techniques. Material and method: The 3Shape program is one of the programs used to design bridges or crowns. Zirconium discs are used on which the designed bridge or crown through the CAD / Design system is operated. CAD / Design system is a system used to design the anatomo-morphological characteristics of the bridge or crown that needs to be made. After the designing, zirconium discs are used for bridge or crown modeling and they are part of the CAD / CAM system. In the case of full zirconia bridges or crowns after their cutting they are stained with paint, and in the case of cut-back zirconia, a bridge construction allows designing a certain space on the vestibular surface to place ceramics. Conclusion: These crowns or bridge are long lasting, naturally lying under the gingiva and showing successful incorporation in the oral environment. Also, zirconium crowns do not have transparency and do not differ from natural teeth, making it very difficult to see the difference between the crown and the already existing natural tooth

A concept for integrated care pathways for atopic dermatitis-A GA 2 LEN ADCARE initiative

The integrated care pathways for atopic dermatitis (AD-ICPs) aim to bridge the gap between existing AD treatment evidence-based guidelines and expert opinion based on daily practice by offering a structured multidisciplinary plan for patient management of AD. ICPs have the potential to enhance guideline recommendations by combining interventions and aspects from different guidelines, integrating quality assurance, and describing co-ordination of care. Most importantly, patients can enter the ICPs at any level depending on AD severity, resources available in their country, and economic factors such as differences in insurance reimbursement systems. The GA 2 LEN ADCARE network and partners as well as all stakeholders, abbreviated as the AD-ICPs working group, were involved in the discussion and preparation of the AD ICPs during a series of subgroup workshops and meetings in years 2020 and 2021, after which the document was circulated within all GAL 2 EN ADCARE centres. The AD-ICPs outline the diagnostic procedures, possible co-morbidities, different available treatment options including differential approaches for the pediatric population, and the role of the pharmacists and other stakeholders, as well as remaining unmet needs in the management of AD. The AD-ICPs provide a multidisciplinary plan for improved diagnosis, treatment, and patient feedback in AD management, as well as addressing critical unmet needs, including improved access to care, training specialists, implementation of educational programs, assessment on the impact of climate change, and fostering a personalised treatment approach. By focusing on these key areas, the initiative aims to pave the way for a brighter future in the management of AD

A concept for integrated care pathways for atopic dermatitis—A GA2LEN ADCARE initiative

Abstract Introduction The integrated care pathways for atopic dermatitis (AD‐ICPs) aim to bridge the gap between existing AD treatment evidence‐based guidelines and expert opinion based on daily practice by offering a structured multidisciplinary plan for patient management of AD. ICPs have the potential to enhance guideline recommendations by combining interventions and aspects from different guidelines, integrating quality assurance, and describing co‐ordination of care. Most importantly, patients can enter the ICPs at any level depending on AD severity, resources available in their country, and economic factors such as differences in insurance reimbursement systems. Methods The GA2LEN ADCARE network and partners as well as all stakeholders, abbreviated as the AD‐ICPs working group, were involved in the discussion and preparation of the AD ICPs during a series of subgroup workshops and meetings in years 2020 and 2021, after which the document was circulated within all GAL2EN ADCARE centres. Results The AD‐ICPs outline the diagnostic procedures, possible co‐morbidities, different available treatment options including differential approaches for the pediatric population, and the role of the pharmacists and other stakeholders, as well as remaining unmet needs in the management of AD. Conclusion The AD‐ICPs provide a multidisciplinary plan for improved diagnosis, treatment, and patient feedback in AD management, as well as addressing critical unmet needs, including improved access to care, training specialists, implementation of educational programs, assessment on the impact of climate change, and fostering a personalised treatment approach. By focusing on these key areas, the initiative aims to pave the way for a brighter future in the management of AD