Asian Journal of Pharmaceutical Research

Abstract

Forced degradation studies are carried out at a more severe condition than accelerated conditions. Stress studies for vaccines are carried out in the early stage of development. By conducting stress studies, we can know the chemical behavior of our molecule which is important while developing formulation, packaging, transportation, storage, etc. there are general regulatory guidelines are available for conducting forced degradation studies but there is no sufficient information provided about how to perform forced degradation studies. Thus, this review discussed stress testing studies of vaccines, mechanisms of vaccine degradation, also analytical methods which are helpful to develop a method for forced degradation.

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Abstract

The coronavirus disease 19(COVID-19) is a highly transmittable and pathogenic viral infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-II), which emerged in Wuhan, China and spread around the world. It is considered a relative of Severe Acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), The cause of COVID-19 is a beta coronavirus named SARS-CoV-2 that affects the lower respiratory tract and manifests as pneumonia in humans. The Asymptomatic carriers have become the current focus of global epidemic prevention and control efforts. These carriers of the virus display no clinical symptoms but are known to be contagious. As "silent spreaders", asymptomatic carriers warrant attention as a part of disease prevention and control. The comparable viral load in a group of asymptomatic carriers of COVID-19 was found to be higher than that of the symptomatic carriers. There are numerous micronutrients which are essential for immunocompetence, particularly Vitamin A, C, D, E, B, iron, selenium, and zinc. Immunonutrition refers to the modulation of the immune system through the modification of dietary nutrients. Vitamins A to E highlighted potentially beneficial roles in the fight against COVID-19 via antioxidant effects, immunomodulation, enhancing natural barriers, and local paracrine signaling. The present review provides a brief information on supplementation of Immunonutrients in form of vitamins which ultimately can act as prophylactic regimen for Asymptomatic carriers of SARS CoV-II virus.

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Abstract

The United States Food and Drug Administration (US FDA) is a department of health and human services federal agency. If the FDA notices major violations of federal regulations, it sends warning letters to pharmaceutical makers, distributors, and clinical investigators. The nature of the infractions discovered, as well as the FDA's proposed corrective activities, are detailed in these warning letters. Following the completion of the corrective activities, the recipient may request a follow-up inspection. This review article examines the current state of warning letters issued by the US Food and Drug Administration (FDA) from 2019 to 2021. The main goal of this study is to examine warning letters related to drug and determine what the significant violations.

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