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PurposeProducts formulated for intramammary (IMM) infusion are intended for the delivery of therapeutic moieties directly into the udder through the teat canal to maximize drug exposure at the targeted clinical site, the mammary gland, with little to no systemic drug exposure. Currently, to our knowledge, there has been no in-vitro matrix system available to differentiate between IMM formulations. Our goal is to develop A custom tailored in-vitro “Matrix of Chemistry, Manufacturing and Control” (MoCMC) System to be a promising future tool for identifying inequivalent IMM formulations. MoCMC can detect inter and intra batch variabilities, thereby identifying potential generics versus brand product similarities or differences with a single numeric value and a specific & distinctive fingerprint.MethodsThe FDA-approved IMM formulation, SPECTRAMASTⓇ LC, was selected as the reference product for the MoCMC. Twelve in-house test formulations containing ceftiofur hydrochloride were formulated and characterized. The MoCMC was developed to include six input parameters and three output parameters. The MoCMC system was used to evaluate and compare SPECTRAMASTⓇ LC with its in-house formulations.ResultsBased on the MoCMC generated parameters, the distinctive fingerprints of MoCMC for each IMM formulations, and the statistical analyses of MCI and PPI values, in-house formulations, F-01 and F-02 showed consistency while the rest of in-house formulations (F-03-F-12) were significantly different as compared to SPECTRAMASTⓇ LC.ConclusionThis research showed that the MoCMC approach can be used as a tool for intra batch variabilities, generics versus brand products comparisons, post-approval formulations changes, manufacturing changes, and formulation variabilities.

Sustainable product engineering is becoming increasingly important. This includes the development of environmentally friendly products and the design for recycling. In this paper a holistic method for the assessment of solution alternatives is presented, in which the stakeholder perspectives along the generic product lifecycle are taken into account. Finally, a new visualization is presented. By visualizing the results in the integrated sustainability triangle, decision-makers in product development can holistically assess the sustainability of the solution alternatives.

Regulatory professionals are employed in academia and government andindustry are involved with a wide range of products, following;medical device, Pharmaceuticals, in vitro diagnostics, cosmetics, nutritional product, biologics and biotechnology, veterinary product. \"The Japanese reimbursement system is streamlined compared to the complicated processes companies need to go through in other countries, with pharmaco-economics rarely used to make listing decisions. [...]Japan has a much lower penetration of generics compared to most of the major markets which is advantageous for the big Pharma\". Japanese Regulatory Authority: PMDA is a regulatory authority of Japan.PMDA continues to improve the safety and public health of nation by reviewing applications for marketing approval of pharmaceuticals and conducting safety measures, medical devices, and providing relief to people who have endure from adverse drug reactions. Steps involved in Registration for Generic drugs in Japan: Foreign Manufacturer Accreditation: A person or company who is calculating to quasi-drugs, manufacture drugs, or medical devices in foreign countries and export those drugs to Japan, where those authorization done by the Minister of Health, and Welfare, Labor as an \"Accredited Foreign Manufacturer\", mentioned in Article 13-3 of PAL, (Pharmaceutical Affairs Law) in the each way that a Japanese manufacturer is licensed.

Purpose The purpose of this paper is to decrease musculoskeletal disorder (MSD) problems using a combined approach including design for Six Sigma, generic product development process, and ergonomic-safety philosophies. Design/methodology/approach A total of 550 students voluntarily participated in this study. Kolmogorov–Smirnov and t-tests were used to analyze the collected anthropometry. A cause-and-effect diagram, Pareto’s chart, a brainstorming session, and a priority matrix were also used to extract the 22 design parameters of the product. Moreover, Cronbach’s alpha values were determined to verify the validity of qualitative and quantitative data. Findings Results showed that students are at a high risk of developing MSD issues. The most serious MSD problems among the students were neck pain (74%), back pain (73%), muscle and joint pain (67%), knee pain (57%), leg pain (54%), etc. Besides, all anthropometrics of males are higher than females except Hip Breadth. Among 12 anthropometries, two measurements and one measurement showed statistical significance at p < 0.01 and p < 0.05, respectively. Six design parameters of the mounted desktop (Seat Height, Desk Height, Seat to Desk Clearance, Seat Width, Seat Depth, and Backrest Height) are the most crucial design parameters to design and develop the product. Practical implications The proposed design of the mounted desktop can be used in different tertiary educational institutes to reduce MSDs among students. Originality/value To the best of the authors’ knowledge, this is the first attempt that introduces a combined approach to reduce MSD issues by applying Six Sigma, a generic product development process, and ergonomics-safety philosophy to design and measurement of 22 design parameters of mounted desktop for university students.

Comparator products should be the products that were shown to be safe and efficacious in pivotal clinical trials to ensure prescribability of generics. The use of a common comparator ensures switchability between generics. The selection of the comparator is a national responsibility and may be different between countries. This paper discusses the current recommendations on selection of comparators, the associated problems, and the possibility of harmonization. Most countries follow the World Health Organization (WHO) recommendations for selecting comparator products and require the comparator product to be obtained from their national markets to ensure switchability between the local comparator and their generics. These recommendations are only feasible in the few countries where the repetition of the bioequivalence study is economically feasible, but they are impracticable in all other countries. Furthermore, the exclusive use of the local comparator to ensure switchability is ethically and scientifically questionable. The innovator product from well-regulated markets should be the global comparator. This harmonization is feasible as the concept already applies in the WHO prequalification program. It is ineffectual to harmonize only the requirements for performing bioequivalence studies, if such a study has to be repeated for every single country simply because of the different comparator products.

The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European requirements and present US Food and Drug Administration guidelines its more relevant novelties such as the following: in order to facilitate the development of generic medicinal products, the EU guideline includes the eligibility for Biopharmaceutics Classification System (BCS)-based biowaivers not only for BCS class I drugs but also for class III drugs with tighter requirements for dissolution and excipient composition. The permeability criterion of BCS classification has been substituted with human absorbability, as per the Biopharmaceutical Drug Disposition Classification System. The widening of the acceptance range for Cmax is possible only for highly variable reference products with an additional clinical justification. This scaled widening is carried out with a proportionality constant of 0.760 which is more conservative than the FDA approach and maintains the consumer risk at a 5% level when the intra-subject CV is close to 30%, due to the smooth transition between the scaled and the constant criteria. The guideline allows for the possibility of two-stage designs to obtain the necessary information on formulation differences and variability from interim analyses as a part of the pivotal bioequivalence study, instead of undertaking pilot studies. The guideline also specifies that the statistical analyses should be performed considering all factors as fixed, which has implications in the case of replicate designs.

Leveraging product differentiation and mass production efficiency in mass customization basically entails a configure-to-order paradigm. In the engineer-to-order (ETO) business, however, companies build unique products in response to ‘foreseeable’ customer specifications. The key challenge of ETO mass customization lies in the complexity of accommodating future design changes when customers are involved in customizing design specifications. This paper proposes a two-stage, bi-level stochastic programming framework to tackle ETO mass customization. At the first stage, product platform configuration is integrated with production reconfiguration, which is formulated as a shortest path problem with resource constraints (SPPRC) to optimize production delays within the capabilities of the process platform. Benders’ decomposition algorithm is applied to solve this optimal configuration problem owing to its high computational efficiency. The second stage scrutinizes the optimal configuration resulting from the first stage for scaling optimization of design parameters (DPs) for each module. All DPs are differentiated by standard or customizable DPs. A bi-level stochastic program is implemented to leverage conflicting goals between the producer (leader) and consumer (follower) surpluses. As a result, ETO customization design is anchored with optimal values of standard DPs and optimal value ranges of customizable DPs. A case study of ship engine and power generator ETO design is presented, demonstrating the feasibility and potential of the ETO mass customization framework.

The geometrical arrangement of a set of quantum states can be completely characterized using relational information only. This information is encoded in the pairwise state overlaps, as well as in Bargmann invariants of higher degree written as traces of products of density matrices. We describe how to measure Bargmann invariants using suitable generalizations of the SWAP test. This allows for a complete and robust characterization of the projective-unitary invariant properties of any set of pure or mixed states. As applications, we describe basis-independent tests for linear independence, coherence, and imaginarity. We also show that Bargmann invariants can be used to characterize multi-photon indistinguishability.

Abstract Disclosure: C. Crompton: None. K. Baum: None. M. Silvey: None. M. Al Mukaddam: None. Background: Teriparatide (Forteo®) is a biologic therapy recommended for use in the treatment of osteoporosis for patients at high or very high risk of fracture. Market exclusivity of Forteo® expired in October 2019 allowing for approval of biosimilars. A biosimilar of Forteo® was approved in the United States in October 2019 through the 505(B)(2) application. This application does not require those seeking approval to conduct safety and efficacy studies on their product for submission and allows submission of studies completed for the reference product instead. This pathway is a faster path to market compared to the biologic license application that is used for approval of generic products. The application for the biosimilar (teriparatide) included a study conducted by the manufacturer that compared change in lumbar spine BMD after 24 weeks in osteoporotic patients taking teriparatide or Forteo®. Results were not published due to limitations in the trial design. There is currently a lack of real-world data demonstrating equivalent safety and efficacy between Forteo® and teriparatide biosimilar. This retrospective study evaluated changes in BMD in osteoporotic patients treated with either Forteo® or teriparatide for 18-24 months. Methods: This retrospective chart review included osteoporotic patients ≥ 18 years of age who received teriparatide or Forteo® prescriptions from the practice location and initiated therapy between October 1, 2019 and October 31, 2022. Patients without DXA results at the conclusion of therapy or who did not complete at least 18 months of therapy were excluded. The primary endpoint was percent change from baseline in BMD of lumbar spine, femoral neck, and total hip. Data was analyzed using a two-tailed Mann-Whitney test with a significance level of 0.05. Results: A total of 108 patients were included: 27 (median age 67 years, 88.9% female) in the teriparatide group and 81 (median age 68 years, 85.2% female) in the Forteo® group.. There was no significant difference in median change from baseline BMD of lumbar spine (+9.6% vs +7.7%, P= 0.56), left femoral neck (1.5% vs 2.8%, P= 0.39), right femoral neck (+1.6% vs +4.4%, P= 0.14), left total hip (+2.4% vs +3.2%, P= 0.24), or right total hip (0.0% vs +1.4% , = 0.71) with teriparatide vs Forteo®, respectively. Adverse effects were reported in 7.4% of patients in teriparatide group and 9.9% of patients in the Forteo® group. Most reported adverse effects were constipation, nausea, and fatigue. Conclusion: In this small retrospective study, effect on bone mineral density and reported adverse events were similar between teriparatide and Forteo® when used for the recommended duration of therapy. Results contribute real-world data to support equivalent efficacy and safety of teriparatide and Forteo® formulations. Presentation: Saturday, July 12, 2025