Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 7, Issue 3, 2020

Ranitidine is a well known H2 blocker antihistaminic drug used for symptomatic relief of heartburn, indigestion, acid indigestion, peptic ulcer and hyperacidity. However, On 13th September 2019, the United States Food and Drug Administration (USFDA) has given an alerting statement regarding the presence of nitrosamine impurity called N-nitrosodimethylamine (NDMA) in ranitidine containing products. Recently, some Read More

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines f Read More

The nutraceutical industry has three main segments, including herbal/- natural products, dietary supplements and functional foods. The dietary supplements market is preliminarily driven by the paradigm shift towards preventive health management practices, amid rising healthcare costs and increasing burden of lifestyle diseases. Rise in healthcare expenditure, increased usage of nutraceuticals product as a substitute to Read More

In pharmaceuticals, raw data management is a tedious process that comprises of obtaining the data, affirming the validity, and preserving the required data to make certain of the quality, accuracy, and timeliness of the one who is using the data. Raw data management makes processing, validation, and other essential functions simpler and less time intensive. It provides actual information, i.e., the information which has no Read More

Poor aqueous solubility, oral bioavailability, inter, and inter-subject variability, and physical stability have always been a concern for pharmaceutical formulation scientists while formulating an oral dosage form. Self-Emulsifying Drug Delivery System (SEDDS) is a promising new approach to mitigating those potential problems. The main advantages of SEDDS are that it increases the solubility and decreases the bio-degradatio Read More

Background: The outlook on “Nano-materials, products, medicine and technology' lacks a consensus on the definition to be considered by regulatory bodies all over the world. Engineered nanoparticles, the formulated products containing nanomaterials, are not subject to any precise regulation pertaining to production, handling and labeling till now. Also, nano medicines holding an immense potential involved in treatm Read More

IVDR is the new regulatory basis for placing IVDs in the market, making them available and putting them into service in the European market. EU IVDR regulation is much bigger than the impact of EU IVDD, which is a bold statement to make, considering the significant industry- wide impact as it presents challenges to the manufacturer. Rather, it is largely a revision that contains guidance on how to fulfill the existing IVDD requir Read More

Background: Cesarean section (CS) done before the onset of labor is called an elective and done during labor is called an emergency CS. During labor, CS may be needed in early(1st) or late(2nd) stages. Earlier studies have shown more maternal and fetal complications when a cesarean is done for the first time in the late stages. Objective: Our objective was to find out whether the maternal and fetal outcomes differ when p Read More