<![CDATA[Applied Drug Research, Clinical Trials and Regulatory Affairs (Volume 10 - Issue 1)]]> https://benthamscience.com/journal/201 RSS Feed for Journals | BenthamScience EurekaSelect (+https://benthamscience.com) 2023-06-14 <![CDATA[Applied Drug Research, Clinical Trials and Regulatory Affairs (Volume 10 - Issue 1)]]> https://benthamscience.com/journal/201 <![CDATA[Misery of Long Haulers of COVID-19 - A Review]]>https://benthamscience.com/article/1299412023-06-14Background: Early in December 2019, Wuhan City, Hubei Province, China, had an epidemic of the Coronavirus illness 2019 (COVID-19), which was brought on by a brand-new severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2). The epidemic was deemed a Public Health Emergency of International Concern by the World Health Organization on January 30, 2020. Many governments have implemented a range of control measures as a result of perceived illness risk.

Objectives: The pandemic revealed that COVID-19 affects a variety of organs in addition to the lungs, including the heart and brain, raising the risk of long-term health consequences. The illness can affect someone's health even after recovery in a variety of ways. The long-term effects of COVID-19 on locals are still being researched. The objective is to compile knowledge regarding the virus and the present Post pandemic complications in Long Haulers.

Methods: We reviewed the body of publicly available literature. To discover publications published between December 2019 and October 2020, we conducted a systematic search utilizing the keywords in online databases such as Pub Med, Scopus, Science Direct, Up to Date, and Web of Science. The review includes peer-reviewed original publications published that matched the qualifying requirements.

Results: Although the majority of patients recovered quickly after receiving COVID-19, the possibility of long-term issues induced by COVID-19 necessitates the search for and research of its late consequences. This article aims to provide a comprehensive assessment of COVID-19 late complications in order to determine how prevalent these symptoms are and who is most likely to be impacted.

Conclusion: There are a number of difficulties with the COVID-19 pandemic that has yet to be resolved. Review of the literature reported several long-lasting clinical problems that affect different phases of health, including chronic fatigue, reduced physical capacity, muscle weakness, increased depression, anxiety, post-traumatic stress disorder and sleep problems. A complete turndown in quality of life has been observed even one year after major Coronavirus outbreaks.

The pandemic revealed that COVID-19 affects a variety of organs in addition to the lungs, including the heart and brain, raising the risk of long-term health consequences even after years making them to be “Long Haulers”.

The causal agent, pathogenesis, immunological responses, epidemiology, diagnosis, therapy, and management of the disease, as well as control and preventive efforts, are all included in this review of the literature.

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<![CDATA[A Comparative Study on Approval of Follow-on Version of Sevelamer Carbonate and Glatiramer Acetate (GA) in US, EU]]>https://benthamscience.com/article/1312922023-06-14Many non-biological drugs, different in terms of their structure and mode of action, pharmacological classification, and therapeutic indication, have a common factor of structural complexity and are grouped as non-biological complex drugs (NBCDs). When an innovator drug nears the time of off-patent, different manufacturers attempt to produce its subsequent version, so the patients will have a cost-effective therapeutic equivalent. Since the innovator molecule is complex, its follow-on drug can be called its true generic version, if its bioavailability, bioequivalence and therapeutic equivalence to the innovator drug are demonstrated. However, it is observed that a case-to-case basis approach is implemented by European Medicines Agency (EMA) and Food and Drug Administration, US (USFDA) in the approval of such drugs and there is no uniformity observed between the two.

In this study, an attempt is made to study the complexity of molecules compare and understand the data requirements, and procedures adopted for the review and approval of such complex products. Therefore, drug sevelamer carbonate and glatiramer acetate are selected for the study. A methodical approach was followed. European assessment reports and drug approvals available in the orange book database of the former two regulatory agencies were studied. It is observed that the generic version of glatiramer acetate is approved as an abbreviated new drug application (ANDA) by Food and Drug Administration whereas the same was approved as the hybrid application by European Medicines Agency requiring the applicant to generate and submit more data. Thus, harmonization of the regulatory requirements for the approval of follow-on versions of such complex drugs is essential for better understanding, predictability of the regulatory process, and acceleration of the drug approval process, in the interest of patients. This will help the faster access of the drugs to the patients and allow interchangeability of the innovator drugs with its cost-effective generic version.

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