This topic aims at reviewing the drug and drug product for filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for the regulation of food and drug product in Europe. TGA is the Regulatory Agency which is responsible for the regulation of therapeutic goods in Australia. A dossier contains detail information about the drug substance and drug product and result of studies that are carried out in development process. For getting market authorization has to be submitted to the respective regulation bodies.CTD provides standardized structure. CTD makes filing easier globally. But there are differences in dossier submission requirements in these countries i.e. Module I is country specific and other regional guideline are also considered while compiling dossier application and Processing. 

Background: In today’s healthcare, evidence based medicine is considered crucial for providing high quality medical services, improving patient satisfaction and reducing costs. In this respect, physicians are expected to play the chief role. The current study aims at assessment of physicians’ practices of EBM in general hospital in Jeddah, SA and explore barriers of practice. Subjects and methods: Through a cross sectional study design, 386 physicians working in two general hospitals responded to a predesigned self-administered questionnaire reflecting their practice of EMB and barriers of practicing it. SPSS ver.21 was used for statistical analysis including Independent sample t test and ANOVA for significant differences and linear regression for determining predictors. Results: The overwhelming majorities of the physicians are Saudis (95.6%), with dominance of young aged <40 years (78.8%), having experience for <10 years (76%) and mainly working as residents (45.3%). The significantly highest EBM practicing score was recorded for male physicians (mean ± SD; 26.1 ± 7.71), non-Saudis (mean ± SD; 29.5 ± 5.57), aged 40-<50 years (mean ± SD; 28.0 ± 7.41), who are Board certified (mean ± SD; 27.4±7.07) and those who are working as consultants (mean ± SD; 28.6 ± 6.71) with a consistent increase in the overall mean score with increasing years of experience, it ranged between 23.0 ± 7.50 in physicians who had experience for less than three years up to 27.6 ± 7.65 in those who had experience for more than 20 years. The main reported barriers were lack of training, understanding statistical analysis, ability to critically appraise the literature and insufficient time. Conclusion: Physicians’ practicing of EBM is still below optimal in general hospitals due to lack of training. 

Diabetic foot ulcer is poorly or non-healing full thickness wound through the dermis, below the ankle in an individual with Diabetes. The main objective of the study was to assess the impact of wound on the quality of life of subjects with Diabetic foot ulcer. Diabetic foot ulcer causes changes in the daily lives of patients, creates limitations to perform daily activities and has an enormous impact on the quality of life both physically and mentally. The study also aimed to determine the risk factors contributing to the development of Diabetic foot ulcer. A total of 42 subjects were enrolled in the study. The mean age of the study population was 57.95 ± 9.95. In DFS the obtained mean and standard deviation of total QOL of patients was 58.68 ± 8.72. Also, there was a significant association found between the variables gender, age, BMI and presence of neuropathy with the QOL domains. The major risk factors identified towards the development of DFU are Peripheral Neuropathy (66.66%), lack of foot care (76.19%) and poorly controlled blood sugar level (61.90%). The study found out that the quality of life and its dimension in patients with DFU's are in low range. While health education is a fundamental obligation of health care professional it is paramount that patients adopt the guidelines of feet care and integrate them into daily life in trying to prevent diabetic foot and its consequences. 

Root Cause Analysis is used as a guidance for the investigation. Root cause analysis (RCA) describes a wide range of approaches, tools, and techniques used to uncover causes of problems. Root Cause Analysis is a systematic approach through the use of set tools and investigative techniques to get to the true root cause of the Quality system issue. Different tools can be used for the Root Cause Analysis to carry out the investigation of any quality system related issues. The general steps of Root cause analysis are to Define the problem, Analyze what is seen and identify the precise symptoms so that one can form a problem statement, Collection of data, Identifying causal factors, Determine the root cause(s), Recommending and implementation of solutions. The main benefit of RCA is that it finds the fundamental errors in the development process, enables teams to enact right measures to fix the problems and stop them from recurring ahead. This article gives a guidance how RCA is performed stepwise to address a problem statement, reach to appropriate solution and implement necessary corrective and preventive actions. 

Animal models are the most commonly used model that helps to improve the understanding of the genetic alterations that occur in humans during the carcinogenic environment. Furthermore, these models play a pivotal role in the illustration of tumorigenesis and therapeutic strategies. With the advancement in molecular biology, the use of nanomedicine for breast cancer treatment has progressed, and more is expected to be done in the future pretrial and clinical models to achieve more success. The biocompatibility of 3D printing platforms has been reported to be adequate in terms of cell viability; however, the effects on gene expression and functional aspects have received less attention. Various mechanical and visual disruptions to cells are involved depending on the type of bioprinter employed. Additional research into the mechanical and optical effects of the bioprinting process will provide more insight into the 3D printing technique' biocompatibility. To investigate the microenvironment of breast tumours and 3D bioprinting methods have also been studied. Modalities for bioprinting include extrusion-based (EBB) printing, droplet-based (DBB) printing and laser-based bioprinting. Different research has indicated that new developments of novel cancer modelling have emerged with 3D bioprinting technology. Those studies need to be properly explained and analyses in a Broadway in this review and to help in the progress of cancer research. 

Background: Stroke is the second leading cause of death worldwide, and the leading cause of acquired disability in adults in most regions. Countries of low? and middle?income have the largest burden of stroke, accounting for more than 85% of stroke mortality worldwide. Aim: The aim of this study was to compare between haemorrhagic stroke (HS) and ischaemic stroke (IS) stroke in relation to risk factors and clinical presentation among stroke patients admitted to a tertiary care teaching hospital. Method: A Retrospective Cross-Sectional study was conducted in FIMS, Kadapa, a 300 bedded tertiary care teaching hospital. The sources of data was collected from patient document forms. The data collected from the prescriptions was entered in data collection forms for evaluation.  Result: 60 stroke patients were categorized based on age, gender, occupation and risk factors like(hypertension, diabetes mellitus, smoking, alcohol etc) Out of 60 stroke cases, 43(71.6%) patients have hypertension as a risk factor(25- ischemic and 18- haemorrhagic), 21(35%) patients have diabetes mellitus as a risk factor(17- ischemic and 4- haemorrhagic), 19(31.6%) patients have smoking as a risk factor (12- ischemic and 7- haemorrhagic ), 16 (26.6%)patients have alcohol as a risk factor ( 11- ischemic and 5- haemorrhagic). Conclusion: We concluded that, old age, diabetes mellitus and smoking were more frequent among Ischemic stroke than hemorrhagic stroke patients. While Hypertension and smoking were found to be major risk factors in hemorrhagic stroke than ischemic stroke patients. Impaired consciousness including coma and in?hospital fatality was more among HS than in IS patients.

Barleria prionitis is a famous perennial plant commonly known as porcupine flower or Vajradanti. It is a shrub with yellow flowers, inhabit most parts of India. Various parts of the plant such as leaves, roots, aerial parts, flowers, and stems are used in the traditional system of medicine. The objective of the study was undertaken to investigate the antimicrobial and wound healing activity of Barleria prionitis leaves extract . The leaves of Barleria prionitis were collected, processed & standardized as per official methods. The extracts of Barleria prionitis leaves were extracted and studied to detect the chemical compounds present by defattying with Petroleum-ether60-800C then successive extraction was done by Ethylacetate & Methanol. Qualitative phytochemical screening revealed the presence of carbohydrates, proteins, flavonoids, tannins, alkaloids & steroids. Total polyphenol content & total flavonoid content was determined using UV-Visible spectrophotometer. DPPH scavenging assay were performed to evaluate the antioxidant capacity of all extracts & they showed maximum antioxidant activity. Then these extracts used to evaluate acute oral toxicity, antioxidant, antimicrobial and wound healing activity. The evaluation of in-vitro antimicrobial and in vivo wound healing activity in rodents was done using various experimental models. Excision model methods were performed to evaluate the wound healing activity by using 1% as well as 2% methanolic extracts ointments and 1% as well as 2% ethyl acetate extracts ointments , in both the extract ointments the rats showed the decreased epithelial size of wound on post wounding days for both 1% as well as 2% methanolic extract and 1% as well as 2% ethyl acetate leaves extract compared to standard group. Along with this the antimicrobial activity was done by using both extracts. In the evaluation of antimicrobial activity , it was found that the Barleria prionitis leaves extracts exhibit significant Antibacterial activity on microorganisms like Bacillus substillus, Staphylococcus aureus & E.coli. The present study shows that Barleria prionitis leaves extract have better wound healing and antimicrobial activity.