ii Abstract The quality of a pharmaceutical product is one of the most challenging considerations of the pharmaceutical industry because it is directly related to the patient health and safety. Every pharmaceutical product should be manufactured by a licensed pharmaceutical manufacturer according to the guidelines, which should be stringently monitored by the licensed pharmacist, in order to attain the target quality product. The guidelines that are followed in the pharmaceutical industry are several, such as the ICH guideline, WHO guideline, FDA guideline, etc. A systematic approach needs to be designed and developed with the ‘end’ in mind, in order to ensure quality where the product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batches. The impact of starting raw materials and process parameters on product quality must surely be well understood, with an emphasis on product and process understanding and process control. All processes involved must be continually monitored, evaluated, documented and updated in line with the ‘quality by design’ approach to allow for consistent quality throughout product life cycle. The aim of the study was to highlight the various approaches and steps involved, and other relevant considerations that a pharmaceutical company must undertake, whether manufactured in-house or by outsourcing, in order to ensure product quality through ‘quality by design’ approach.

An overview of established practices and parameters to ensure quality of a pharmaceutical product

Nucleoside analogues (NAs) are a family of compounds which include a variety of purine and pyrimidine derivatives, widely used as anticancer and antiviral agents. For their ability to compete with physiological nucleosides, NAs act as antimetabolites exerting their activity by interfering with the synthesis of nucleic acids. Much progress in the comprehension of their molecular mechanisms has been made, including providing new strategies for potentiating anticancer/antiviral activity. Among these strategies, new platinum-NAs showing a good potential to improve the therapeutic indices of NAs have been synthesized and studied. This short review aims to describe the properties and future perspectives of platinum-NAs, proposing these complexes as a new class of antimetabolites.

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Platinum-Nucleos(t)ide Compounds as Possible Antimetabolites for Antitumor/Antiviral Therapy: Properties and Perspectives

Objective To establish and consummate the quality control project by testing medical infusion pumps and injection pumps in order to ensure the clinical use to be safe,accurate and efficient.Methods Infusion device analyzer INFUTEST 2000E(double channel) made by ALK in Sweden was used to measure the fluid,flow and occlusion alarm.Results Through annual test of all the infusion pumps and injection pumps from all departments of our hospital,the equipment with quality problems was repaired in order to ensure the clinical use.Conclusion The test result can be used as a reference during the process of equipment checking,quality control and maintenance.

Quality Control and Test Methods for Infusion Pump and Injection Pump

Present study deals with a brief overview of comparative study of quality requirements for in process and finished product quality control test of IP, BP and USP for some conventional dosage forms. The concept of IPQC refers to the process of striving to produce a quality product by a series of measures requiring an organised effort in order to eliminate errors at every stage in the production. Main function of IPQC is monitoring and if necessary adaption of the manufacturing process in order to comply with the specifications this may include control of equipment and environment. In process materials should be tested for identity, strength and quality and purity as appropriate and approved (or) rejected by the quality Assurance department. During the production process rejected in process materials should be identified and controlled under a Quarantine system designed to prevent their use in manufacturing. IPQC is done to comply Concurrent Validation also.

An Updated Review on IPQC Tests for Sterile and Non Sterile Products

Occlusal analysis is essential in the dental clinical practice. However, the traditional occlusal analysis performed on the two-dimensional level can not directly correspond to the tooth surface with three-dimensional profile, therefore the clinical guidance value is limited.By combining the 3D digital dental models and quantitative data from 2D occlusal contact analysis, this study constructed a novel digital occlusal analysis method. The validity and reliability of DP and SA were verified by comparing the results of occlusal analysis of 22 participants. ICC values for occlusal contact area (OCA) and occlusal contact number (OCN) were tested.Results confirmed the reliability of the two occlusal analysis methods with ICC values of 0.909 for SAOCA, 0.906 for DPOCA, 0.929 for SAOCN and 0.904 for DPOCN. The Bland-Altman plot, paired t-test (tOCN = 0.691, P > 0.05) and Pearson correlation analysis results (R = 0.68, p < 0.001) verified the validity between SA and DP. Then a novel digital occlusal analysis method was constructed, which not only can locate the occlusion contact and provide the quantitative analysis, but also provide a comprehensive description of the resultant force of each tooth and the component forces on the x-, y- and z-axis.This new occlusal analysis method can obtain quantitative analysis of occlusal contact including contact area and force information simultaneously, which will provide new impetus and greater help for clinical dental treatment and scientific research. 

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Construction of a novel digital method for quantitative analysis of occlusal contact and force

Corresponding author * Pragyandip Parthasarathi Dash, Asst.Professor, Amity University, Lucknow E-mail: parthasarathi27@gmail.com The foremost aim of pharmaceutical Industry is quality control which is an indispensable section that mention to a procedure of endeavoring to manufacture formulations with stringent measures demanding a systematized effort by single individual of the industry to ensure and reduce the errors in the manufacturing processes. As quality is prime importance part of pharmaceuticals, quality control plays the vital role in achieving it. Quality control includes sampling, testing, validation, documentation and release of procedure which ensure that all tests are actually carried out prior to release of material for sale. Injectable are essentially manufactured in the sterile and aseptic zone where no microbial growth is possible. These are tested under the Quality Control and assured by the Quality Assurance. In-processes quality control assures sterility, freedom from particulate matter, and leakage. stringent procedure are followed for the preparation as well as the quality control test of the injectable to achieve the quality and safety of the product for use .So we became interested about current study to provide the careful orientation of the in process quality control of injectable.

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A Methodical Review on Industrial Manufacturing and In-process Quality Control of Injectables

Simple Summary Anticancer nucleoside analogs are promising treatments that often result in damaging toxicities and therefore ineffective treatment. Mechanisms of this are not well-researched, but cellular nucleoside transport research in mice might provide additional insight given transport’s role in mammalian hematopoiesis. Cellular nucleoside transport is a notable component of mammalian hematopoiesis due to how mutations within it relate to hematological abnormities. This review encompasses nucleoside transporters, focusing on their inherent properties, hematopoietic role, and their interplay in nucleoside drug treatment side effects. We then propose potential mechanisms to explain nucleoside transport involvement in blood disorders. Finally, we point out and advocate for future research areas that would improve therapeutic outcomes for patients taking nucleoside analog therapies. Abstract Anticancer nucleoside analogs produce adverse, and at times, dose-limiting hematological toxicities that can compromise treatment efficacy, yet the mechanisms of such toxicities are poorly understood. Recently, cellular nucleoside transport has been implicated in normal blood cell formation with studies from nucleoside transporter-deficient mice providing additional insights into the regulation of mammalian hematopoiesis. Furthermore, several idiopathic human genetic disorders have revealed nucleoside transport as an important component of mammalian hematopoiesis because mutations in individual nucleoside transporter genes are linked to various hematological abnormalities, including anemia. Here, we review recent developments in nucleoside transporters, including their transport characteristics, their role in the regulation of hematopoiesis, and their potential involvement in the occurrence of adverse hematological side effects due to nucleoside drug treatment. Furthermore, we discuss the putative mechanisms by which aberrant nucleoside transport may contribute to hematological abnormalities and identify the knowledge gaps where future research may positively impact treatment outcomes for patients undergoing various nucleoside analog therapies.

https://www.mdpi.com/2072-6694/14/13/3113/pdf?version=1656390325

Solute Carrier Nucleoside Transporters in Hematopoiesis and Hematological Drug Toxicities: A Perspective

Knowledge of the effect of a shortened dental arch on masseter muscle thickness and occlusal force is sparse but could help clinicians understand how a shortened dental arch might affect the stomatognathic system.The purpose of this pilot clinical study was to evaluate and compare the masseter muscle thickness and occlusal force of participants rehabilitated by using a shortened dental arch with matched completely dentate individuals.Twelve partially edentulous participants with a minimum of 1 posterior occluding pair on each side of the arch were enrolled in the study. The mandibular arch of these participants was rehabilitated by using a single posterior mandibular implant crown (group S). The maxillary arch of all participants in group S was intact. Masseter muscle thickness (cm) and occlusal force (N) were recorded before (T1) and 6 months after implant rehabilitation (T2) for each participant. Twelve participants were selected as controls (group C). They were matched for age, sex, height, and weight with group S and evaluated for masseter muscle thickness and occlusal force. Masseter muscle thickness was evaluated by using ultrasonography during the rest position and maximum volumetric clenching. Occlusal force was measured with an occlusal force measuring appliance. All recordings were done for the left and right sides of the arch. Descriptive analysis was followed by comparison between groups and within group S by using the paired t test (α=.05).Higher masseter muscle thickness and higher occlusal force were observed in group C than in group S before and after rehabilitation. An increase in masseter muscle thickness in the rest position and in maximum volumetric clenching was observed within group S after rehabilitation. Before rehabilitation, a difference in the masseter muscle thickness between group S and group C was statistically significant for the left side at the rest position (P=.017) and during maximum volumetric clenching (P=.016). After rehabilitation, the difference between group S and group C was not statistically significant for masseter muscle thickness at the rest position (P=.890 for right side and P=.555 for left side) and during maximum volumetric clenching (P=.109 for right side and P=.755 for left side). The difference in occlusal force between group S and group C was statistically significant for the right side and left side (P<.001) before rehabilitation and statistically not significant after rehabilitation (P=.161 for the right side and P=.134 for the left side).Rehabilitation following the concept of a shortened dental arch increased masseter muscle thickness and occlusal force in partially edentulous individuals, making the masseter muscle thickness and occlusal force comparable with those of a completely dentate arch. 

Effect of rehabilitation by using the shortened dental arch concept on the thickness of the masseter muscle and occlusal force: A pilot study.

Purpose: The treatment priority in management of Temporomandibular Joint (TMJ) pain is directed towards the causative factor along with symptomatic treatment. In this process many times psychological aspect is overlooked. Hence with this pilot study, importance of psychological aspect of Temporomandibular Joint Disorder (TMD) is emphasised. Methods and Material: 15 patients suffering from pain in TMD region who qualify under myalgia pain in DC/TMD Axis I category were selected. Patients were divided into 3 groups; Ibuprofen, placebo and occlusal splint with 5 patients in each group. Pain assessment was done at the first visit, 7th day visit and 14th day visit using a VAS scale. Statistical Analysis Used: Friedman Test was applied to determine overall relief from pain in the three groups. Wilcoxon sign rank test evaluated pain relief between each time interval. Kruskal Wallis Test compared different groups for relief from pain at each time interval. Key Finding: Wilcoxon sign rank test showed a significant pain relief in all three groups from I day to I follow up day and I day to II follow up day. However Pain relief from I follow up to II follow up day was significant only in placebo group. Conclusions: Management of TMD myalgia requires a comprehensive understanding of physical and psychological aspect. This will aid us in formulating a treatment plan comprising pharmacotherapy, placebo or physical therapy or combination of any of these.

An In-vivo Study to Evaluate the Onset of Relief from Ibuprofen, Placebo and Occlusal Splint in Patients with Acute Myalgia in Muscles Related to Temporomandibular Joint: A Comparative Pilot Study

Ruchika Raj

Papers

A Methodical Review on Industrial Manufacturing and In-process Quality Control of Injectables

Solute Carrier Nucleoside Transporters in Hematopoiesis and Hematological Drug Toxicities: A Perspective

Effect of rehabilitation by using the shortened dental arch concept on the thickness of the masseter muscle and occlusal force: A pilot study.

An In-vivo Study to Evaluate the Onset of Relief from Ibuprofen, Placebo and Occlusal Splint in Patients with Acute Myalgia in Muscles Related to Temporomandibular Joint: A Comparative Pilot Study