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This first in human study was designed as an open label clinical trial to assess the safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) Tdap vaccine in healthy adult volunteers, aged 18–45 years. A total of 24 healthy adults were administered a 0.5 ml single dose of SIIPL Tdap vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events. 23 subjects completed the study in compliance with the study protocol. None of the participants experienced any immediate adverse events or any local or systemic solicited adverse events. Tdap vaccine manufactured by Serum Institute of India Pvt. Ltd. is safe and well tolerable in adults. It was concluded that further clinical development of this vaccine should continue to assess its safety and immunogenicity, in the target population. Clinical Trial Registration – CTRI/2017/03/008003.

Rotavirus Gastroenteritis (RVGE) is an important global public health problem. Recently a Lyophilized Pentavalent Human Bovine Reassortant Rotavirus vaccine (BRV-PV, Rotasiil) was licensed in India. A Liquid formulation of the same vaccine (LBRV-PV) was tested in a Phase I clinical trial. Total 20 healthy adults were given a single oral dose of LBRV-PV and were followed for one month for safety outcomes: immediate reactions, solicited reactions, unsolicited adverse events and serious adverse events. All 20 adults completed the study without any major protocol deviations. No immediate reaction, solicited reactions and unsolicited adverse events were reported during the study. No clinically significant changes were seen in the vital parameters and safety laboratory test results. LBRV-PV developed in India was safe and well tolerated in adults. Further clinical development of this vaccine in infants should be undertaken. Trial Registration – CTRI/2015/11/006,384.

Reticulocyte invasion by Plasmodium vivax requires interaction of the Duffy-binding protein (PvDBP) with host Duffy antigen receptor for chemokines (DARCs). The binding domain of PvDBP maps to a cysteine-rich region referred to as region II (PvDBPII). Blocking this interaction offers a potential path to prevent P. vivax blood-stage growth and P. vivax malaria. This forms the rationale for development of a vaccine based on PvDBPII. Here we report results of a Phase I randomized trial to evaluate the safety and immunogenicity of recombinant PvDBPII formulated with glucopyranosyl lipid adjuvant-stable emulsion (GLA-SE). Thirty-six malaria-naive, healthy Indian male subjects aged 18–45 years were assigned into three cohorts corresponding to doses of 10, 25 and 50 µg of PvDBPII formulated with 5 µg of GLA-SE. Each cohort included nine PvDBPII/GLA-SE vaccinees and three hepatitis B control vaccine recipients. Each subject received the assigned vaccine intramuscularly on days 0, 28 and 56, and was followed up till day 180. No serious AE was reported and PvDBPII/GLA-SE was well-tolerated and safe. Analysis by ELISA showed that all three doses of PvDBPII elicited antigen-specific binding-inhibitory antibodies. The 50 µg dose elicited antibodies against PvDBPII that had the highest binding-inhibitory titres and were most persistent. Importantly, the antibody responses were strain transcending and blocked receptor binding of diverse PvDBP alleles. These results support further clinical development of PvDBPII/GLA-SE to evaluate efficacy against sporozoite or blood-stage challenge in controlled human malaria infection (CHMI) models and against natural P. vivax challenge in malaria endemic areas.

Background and objective:Concern about lowering health care costs has resulted in a tremendous increase in the use of generic drug products. Thus Bioavailability and Bioequivalence of drug products, and drug product selection have emerged as critical issues in pharmacy and medicine during the last three decades. The purpose of this study was to know the clinical procedure of BA/BE studies conducted in Contract Research Organization, to know the roles and responsibilities of different individuals involved in BA/BE studies and to know the process of selection of volunteers for conducting the BA/BE studies.Method:An observational study was conducted at the Human Pharmacology Unit of Clinigene International Private Limited during November 2005 to April 2006. During this study period, the process for conducting BA/BE studies and role and responsibility of different individual(s) was observed at Clinigene-HPU. A total of 34 volunteers were screened for knowing the process of selection of volunteers, out of which 21 volunteers passed after screening process. The complete data was obtained by means of direct interview, questionnaires, GPE forms and CRFs.Results:A total of 34 volunteers were screened for conducting the study, out of which 21(61.76%) volunteers passed and 13 (38.24%) volunteers failed after the process of screening. The common reason observed for the failure of volunteers was increase in Eosinophil count (30.77 %). The other reasons observed for failure of volunteers was high alkaline phosphatase, presence of blood in urine, high SGOT and SGPT levels, high cholesterol and triglyceride and low hemoglobin levels. The volunteers selected for the study were aged between 19-31 years and with BMI between 19.7-24 Kg/m2 . The volunteers participating in the study were non-smokers and non-alcoholics.Conclusion:The study conducted at Clinigene –HPU was according to the protocol, SOP, ICH GCP guidelines and regulatory authorities guidelines. All the personnel at Clinigene-HPU involved in the BA/BE studies performed their duties sincerely as per the job responsibilities assigned to them.

  After we tested the pH and turbidity and we saw what invertebrates lived in different locations of the river, we figured out our rivers weren't polluted.

Isatin (1H indole 2, 3-dione) is a heterocyclic, endogenous lead molecule recognized in humans and different plants. The isatin nucleus and its derivatives are owed the attention of researchers due to their diverse pharmacological activities such as anticancer, anti-TB, antifungal, antimicrobial, antioxidant, anti-inflammatory, anticonvulsant, anti-HIV, and so on. Many research chemists take advantage of the gentle structure of isatins, such as NH at position 1 and carbonyl functions at positions 2 and 3, for designing biologically active analogues via different approaches. Literature surveys based on reported preclinical, clinical, and patented details confirm the multitarget profile of isatin analogues and thus their importance in the field of medicinal chemistry as a potent chemotherapeutic agent. This review represents the recent development of isatin analogues possessing potential pharmacological action in the years 2016–2020. The structure–activity relationship is also discussed to provide a pharmacophoric pattern that may contribute in the future to the design and synthesis of potent and less toxic therapeutics.

In this work, activated carbon was synthesized by the carbonization of kendu fruit peel followed by chemical activation using ammonium carbonate as an activating agent to get modified kendu fruit peel (MKFP). The SEM and FESEM images of the biomaterial illustrated a highly porous honeycomb-like structure, further supported by the N 2 sorption isotherm analysis. The FTIR spectra specified the presence of oxygen-containing functional groups such as carboxyl, carbonyl, and hydroxyl on the adsorbent surface. Batch experiments were performed for the optimization of methylene blue (MB) dye removal. The adsorption process followed pseudo-second-order kinetic model and Langmuir isotherm model with a maximum adsorption capacity of 144.9 mg g −1 . No desorption was found because the adsorbent surface was bonded with the chromophoric group of the MB dye by means of strong chemical interaction evident from the high adsorption energy ( E  = 10.42 kJ mol −1 ) and enthalpy change (∆H  = 42.7 kJ mol −1 ). Hence, the MKFP has the potential to act as an efficient bioadsorbent for MB dye removal. Graphical abstract

A major global health risk has been witnessed with the development of drug-resistant bacteria and multidrug-resistant pathogens linked to significant mortality. Coumarins are heterocyclic compounds belonging to the benzophenone class enriched in different plants. Coumarins and their derivatives have a wide range of biological activity, including antibacterial, anticoagulant, antioxidant, anti-inflammatory, antiviral, antitumour, and enzyme inhibitory effects. In the past few years, attempts have been reported towards the optimization, synthesis, and evaluation of novel coumarin analogues as antimicrobial agents. Several coumarin-based antibiotic hybrids have been developed, and the majority of them were reported to exhibit potential antibacterial effects. In the present work, studies reported from 2016 to 2020 about antimicrobial coumarin analogues are the focus. The diverse biological spectrum of coumarins can be attributed to their free radical scavenging abilities. In addition to various synthetic strategies developed, some of the structural features include a heterocyclic ring with electron-withdrawing/donating groups conjugated with the coumarin nucleus. The suggested structure−activity relationship (SAR) can provide insight into how coumarin hybrids can be rationally improved against multidrug-resistant bacteria. The present work demonstrates molecular insights for coumarin derivatives having antimicrobial properties from the recent past. The detailed SAR outcomes will benefit towards leading optimization during the discovery and development of novel antimicrobial therapeutics.