Teratology is the science that studies the causes, mechanisms, and patterns of abnormal behavior andmetabolic disorder development. Developmental disorders present at birth are called congenital anomalies, birth defect orcongenital malformation. Originally Teratology study was conceived as the gross of structural malformations and that birthobservable can be associated to some disturbances in the developmental. Teratogenicity, the capacity of an agent to producebirth defects, is governed by certain factors described as Principles of Teratology. Developmental stage at the time ofexposure, Dose and duration of exposure, Genotype of the embryo, Mechanisms of action is specific and may involveinhibition of specific biochemical or molecular process; cell death; decreased cell proliferation or other cellular phenomena.

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the CTD format and was developed by the ICH Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use agreed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of content is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically. In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the file’s integrity guaranteed by the MD5 Checksum. The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). This Thesis describes the various types of submission types, Validation Criteria rules and documents required to submit a successful submission to USFDA through ESG WebTrader. The significance of electronic submissions to health authority is less manual work, accurate results and fast reviewing. KEY WORDS: eCTD, ESG, FDA Meeting Requests, Orphan Drug Applications, INDs, NDAs, ANDAs, Annual Reports, amendments and supplements.

Stavudine is a prescription medicine used to treat AIDS and HIV infection. Stavudine belongs to a group of medications known as nucleoside reverse transcriptase inhibitors (also known as NRTIs). Stavudine is an extremely metabolized drug on oral administration. Due to its sudden metabolism the t1/2 of Stavudine has been decreased to 0.5 hrs which is major limitation for Stavudine as immediate release dosage form. Therefore the present investigation is concerned with the development of Stavudine extended release (ER) tablets by using different hydrophobic and hydrophilic polymers like Ethocel (ethyl cellulose), Methocel (Hydroxy propyl methyl cellulose) polymers in different ratios. Stavudine along with polymers and other ingredients were directly mixed and compressed by using rotary tablet punching machine (Cadmach). After formulation those tablets were evaluated for weight variation, content uniformity, In-Vitro drug release, and stability. Eight combinations having polymers at different proportions were prepared to access their efficacy. Tablets containing 90% ethyl cellulose and 10% hydroxyl propyl methyl cellulose showed superior organoleptic properties and In-Vitro drug release studies as compared to other formulations. The kinetic model of the release data indicates that Stavudine release from the tablets followed Korsemayer-Peppas model and release was found to be Case-II transport (polymer swelling). Thus the release from the prepared formulations was found to be diffusion controlled.

KEY WORDS: Formulation, Evaluation, Stavudine, Extended Release

Humans find food and medicines from nature which were used to treat and heal many ailments. The anti-ulcer
activity of methanolic extract of roots of Solanum melanoxylon (solanaceae) was investigated in Pyrolus ligation ulcer
and Ethanol induced ulcer models in Wistar albino rats. The methanolic extract of Solanum melanoxylon at doses of 200
mg/kg p.o, 400 mg/kg p.o, showed dose dependant significant inhibition of the gastric lesions in both the models. The
extract showed significant (P<0.01) reduction in gastric content volume, free acidity and ulcer index when compared to
control. Results prove that methanolic extract was found to possess anti-ulcerogenic as well as ulcer healing properties,
which might be due to its anti-secretory activity

The small growths (known as polyps) in colon are often benign, although some have the potential to develop and
become cancerous. It is estimated that up to two thirds of colorectal polyps are pre-malignant and associated with a risk
of colorectal cancer (WHO, 2008). Cancers of the large and small intestine are major contributors to worldwide cancer
morbidity and mortality. Out of all the cancers colon cancer is one of the most common cancers in the world. However,
there are often no initial symptoms and the cancer may already have spread to other parts of the body by the time the
patient is diagnosed. As a part of chemotherapy, lots of anticancer drugs are in the market, but the main problem
associated with these drugs is their side effects. Because of chemotherapy treatment side effects, the patient needs
secondary palliative care treatment. Plant medicines are well known for their non-toxic side effects, so the objective of
the study is to develop a drug from medicinal plant against colon cancer with non-toxic side effects. It plays an important
role in the discovery of lead compound for development of conventional drugs. In the present study, capsules were
prepared by incorporating herbs into them and then studying them for their anti-cancer potential to establish a potent
formulation

This study conducted an evaluation of conventional (free-form) and structured radiology reports of body computed tomography (CT) scans at a tertiary care cancer center, involving referring physicians, attending radiologists, radiology fellows, and radiology residents. A total of 330 body CT scan reports were assessed, including those generated by conventional and structured methods, as well as reports by radiology fellows, surgeons, and medical oncologists. Reports were selected based on diagnoses provided by nonradiologists. Physicians rated the content and clarity of 30 reports on a scale from 1 to 10, ranging from extremely dissatisfied to exceptionally clear. Effectiveness of each report was evaluated using a previously established scale for grading radiology reports. A mixed-effects model was utilized to analyze differences between the two types of reports. Results indicated a significant difference (P < 0.002) in content satisfaction between conventional and structured reports, with structured reports receiving higher ratings (mean score of 8.16) compared to conventional ones (mean score of 7.61). Structured reports also demonstrated significantly greater clarity (P < 0.002) than conventional reports. However, no significant difference in grade ratings was observed between the two report types. Overall, structured reports were found to provide more information and were easier to understand among referring clinicians and radiologists compared to conventional reports. These findings underscore the potential benefits of structured reporting in improving the content and clarity of radiology reports, ultimately enhancing communication and decision-making in clinical practice.

Tooth loss is a common oral health problem that can significantly affect an individual's ability to chew, speak, and maintain facial aesthetics, thereby negatively influencing psychological well-being, social interactions, and overall quality of life. Prosthodontic rehabilitation plays a critical role in restoring oral function and appearance through the replacement of missing teeth and supporting structures. A total of 120 patients receiving prosthodontic treatment completed the OHIP-14 questionnaire before treatment and during the post-treatment follow-up period. Changes in overall and domain-specific OHIP-14 scores were evaluated using paired statistical tests, and factors influencing the magnitude of improvement were examined. The results demonstrated a substantial and statistically significant improvement in patient-reported quality of life following prosthodontic rehabilitation. Mean total OHIP-14 scores decreased from 24 before treatment to 11 after treatment, indicating a marked reduction in the negative impact of oral health problems on daily life (p < 0.001). Significant improvements were observed across all OHIP-14 domains, reflecting enhanced oral function, reduced pain and discomfort, improved psychological well-being, greater social confidence, and better overall life satisfaction. Patients with greater baseline impairment experienced larger improvements in quality of life, suggesting that those with the greatest treatment need derived the most benefit from rehabilitation. Furthermore, individuals who underwent complete prosthodontic rehabilitation demonstrated significantly greater gains than those receiving more limited treatment. These findings highlight the substantial positive impact of prosthodontic care on patient-centred outcomes and emphasize the importance of considering quality-of-life measures alongside traditional clinical indicators when evaluating treatment success. In conclusion, prosthodontic rehabilitation significantly enhances oral health-related quality of life across multiple functional, psychological, and social dimensions, underscoring its value in restoring not only oral health but also overall well-being and quality of life. The results support the continued integration of patient-reported outcome measures such as the OHIP-14 into routine prosthodontic assessment and clinical decision-making.