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