The coronavirus disease 2019 (COVID-2019) pandemic caused by novel severe acute respiratory syndrome corona virus-2 (SARS-CoV2) has pushed the scientific community to face a challenge to find solution to its spread, specific therapeutic agents and an efficacious vaccine. In the past also, other similar viruses like SARS-CoV and middle-east respiratory syndrome (MERS)-CoV have made the world face pandemic like situations. These three coronaviruses causing pandemic like situation belong to beta-CoV and despite the similarities between their structure and genome, they differ significantly epidemiologically. These viruses were first discovered in 1960s and were named after their crown like shape appearance. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) was initially identified in Wuhan, China in December 2019 and since then it has spread globally and affected millions of people till date. Interaction between the viral spike protein and angiotensin converting enzyme 2 (ACE2) cell receptor causes the entry of the virus into the host cell. The virus shows its effect in form of flu like symptoms, pneumonia and respiratory tract infection. This review summarizes the epidemiology, pathogenesis along with the host immune system response to the virus and some of the vaccine candidates

The key to executing a successful validation is defining the exact process to be validated. Each parameter included in the manufacturing instructions must have a documented control space that has been established based on experimental or manufacturing data, as well as the quality of the starting materials and the capability of the operators, facility, equipment, and utilities. This requires an evaluation of historical data, deviations, and planned experiments during clinical batches.

One of the emerging challenges in critical care pharmacy practice is the implementation of pharmacovigilance with drugs administered in the intensive care unit. Although the role of intensivists is the main pillar for such a significant topic, but the role of critical care pharmacists is a game changer in terms of advancing the practice of administering drugs to critically ill patient age category, i.e. pediatric patients.

International collaboration is key for the fair and efficient distribution of COVID-19 vaccines. In this paper, we aim to review and analyze the vaccine nationalism phenomenon; which countries have acquired the majority of available vaccine doses in the world and how that impacts the global economy; the costs associated with COVID-19; the appearance of new variants; and the importance of global cooperation mechanisms like COVAX to solve the vaccine nationalism problem.

Introduction/Background: Dapsone (Aczone®) gel 5% was approved in the United States for the topical treatment of acne vulgaris. A generic formulation is being developed by Dr Reddy’s and the objective of the study was to evaluate the bioequivalence (BE) of the test product, rela-tive to the reference product- dapsone gel 5% (RLD) in healthy human subjects under fasting conditions to meet the regulatory requirements. Methods: An open-label, randomized, single-dose, two-sequence, four-period fully replicated crossover study separated by a washout period of 18 days. 48 subjects were randomized to receive either of the two treatment arms (test or RLD). The plasma samples were analyzed for dapsone using a validated LC-MS/MS method. Based on the estimated within-subject standard deviation of the RLD (SWR) for ln-transformed pharmacokinetic (PK) parameters Cmax, AUC0-t and AUC0-∞ of dapsone, the BE of test formulation with respect to RLD was determined either using average BE (ABE) or scaled average BE (SABE) criteria. Results: The statistical analysis results demonstrated that SWR ≥ 0.294 for Cmax, hence BE evaluated using SABE approach. The 95% upper confidence bound for (μT-μR)2-θ*S2WR was ≤ 0, where μT and μR were least square mean of the ln-transformed PK parameters for test and reference. The T/R ratio was within the acceptance criteria of 80 to 125%. For AUCs, the SWR < 0.294, hence BE was evaluated using ABE approach. The 90% confidence intervals (CIs) of ln-transformed data of AUC0-t and AUC0-∞ were within regulatory acceptance limit. Conclusion: The test product was bioequivalent to the RLD in terms of both rate and extent of absorption.