Development and Validity of Questionnaire for Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study

Participation of humans in clinical research is always remained questionable. Hence evaluation of such doubt helps to conclude the perception about such participation. This research presents the process for development and validation of questionnaire for Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For development of questionnaire, literature search, experts’ discussion and authors’ experience was used for domain identification and its segregation for different variables. For validity of questionnaire, face validity and content validity was performed. Modification was done based on response from experts during non-quantitative face validity. % of overall agreement was 94.55 for question asked in face validity. While, Content Validity Ratio and Content Validity Index was calculated using the process mentioned by Lawshe and Lynn respectively. Initially 83 items were identified but based on validation 84 items were finalized after removal of three and addition of four questions. Deleted three items had Content Validity Ratio of 0.00, 0.67 and 0.67 and which were below accepted level of 0.99. While, I-CVI was observed from range of 0.83 to 1.00 and S-CVI values were above acceptable level of 0.90 for S-CVI (S-CVI/ Ave) and 0.80 for S-CVI (S-CVI/UA) for whole questionnaire and each part.

Review on Antifungal Agents

There are so many type of daisies are founded because of ‘Fungal’ such daisies given in follow. also the treatment on this particular daisies with the help of ‘Anti-fungal’ drug or anti- fungal agent and anti-fungal medication as follows The four main classes of antifungal drugs are the polyenes, Azoles, allylamines and echinocandins. Clinically useful “older” agents include topical azole Formulations (for superficial yeast and dermatophyte Infections), first-generation triazoles (fluconazole and Itraconazole, for a range of superficial and invasive fungal Infections), amphotericin B formulations (for a broad range of Invasive fungal infections) and terbinafine (for dermatophyte Infections). Clinically important “newer” agents include members of the Echinocandin class (eg, caspofungin) and second-generation Triazoles (eg, voriconazole and posaconazole). Voriconazole and posaconazole have broad-spectrum activity Against yeasts and moulds, including Aspergillus species. Posaconazole is the only azole drug with activity against Zygomycete fungi. Caspofungin and the other echinocandins are effective in Treating Candida and Aspergillus infections. The azoles are relatively safe, but clinicians should be aware of drug–drug interactions and adverse effects, including Visual disturbances (with voriconazole), elevations in liver Transaminase levels, and skin rashes. Caspofungin has Minimal adverse effects. Combination antifungal therapy may be appropriate in Selected patients with invasive fungal infections, but is Empiric and driven by individual physician practice. Clinical needs for novel antifungal agents have altered

Review on Adverse effects or side effects of Remdisivir

In March 2020, the World Health Organization declared the spread of SARS-CoV-2 a global pandemic. To date, coronavirus disease-2019 (COVID-19) has spread to over 200 countries, leading to over 1.6 million cases and over 99,000 deaths. Given that there is neither a vaccine nor proven treatment for COVID-19, there is currently an urgent need for effective pharmacotherapy. To address the need for an effective treatment of SARS-CoV-2 during the worldwide pandemic, this systematic review of intravenous (IV) remdesivir was performed. Remdesivir, an anti-viral prodrug originally developed to treat Ebola virus disease, has shown broad spectrum activity against the Coronavirus family. A recent case report reported improvement of clinical symptoms with remdesivir in a patient with COVID-19. After conducting a systematic search of 18 clinical trial registries and three large scientific databases, we identified 86 potentially eligible items. Following removal of duplicates (n = 21), eligible studies were reviewed independently by two authors. After the first round of screening, inter-rater agreement was 98.5% (κ = 0.925). After the second round of full-text screening, inter-rater agreement was 100%. A total of seven ongoing and recruiting clinical trials of remdesivir (100–200 milligrams, intravenous [IV]) were included. We identified the following primary outcomes: patients discharged (n = 2); time to clinical status improvement (n = 2); improved O2 saturation (n = 2); body temperature normalization (n = 2); and clinical status (n = 1). Secondary outcomes in all identified studies included documentation of adverse events. Phase 3 trials are expected to be completed between April 2020–2023. Therefore, despite supportive data from in vitro and in vivo studies, the clinical effectiveness of IV remdesivir for treatment of COVID-19 and potential side effects remain incompletely defined in the human population. But the remdesivir is also harmful for the people because of it can have some side effects such as mentioned in the following information. There are so many type of disease started form the treatment of COVID-19 with the Remdesivir that also mentioned in the following review paper.

Checklist to select contract Research Organization for early phase Bioavailability/Bioequivalence Clinical Studies in Healthy Adult Human Volunteers

Nowadays health agencies of regulated markets are becoming stringent regarding the bio-studies. So clinical/contract research organization (CRO) need to be selected carefully after their detailed assessment. As per requirement of bio-study CRO should be assessed with the study specific checklist of questions before awarding the bio-study. Questions related to various services of study like: Clinic phase, analytical phase, Pharmacokinetic and statistical phase, ethics approval, QA/QC, record handing etc. and related to CRO capabilities are discussed here with their relevance to conclude the abilities of CRO for successful execution of bio-study. Hence, this paper focuses all possible questions which need to be assessed before selection of CRO mainly for Bioavailability/Bioequivalence (BABE) study in healthy adult volunteers. Properly selected CRO will help for smooth execution of study and quality report and subsequently, hassle-free approval of dossier submitted to regulatory agency.

A Short Review on study on different Clinical trials Performed on drugs before it Comes into The Market

To study the topic we have used the detail study of various phases of clinical trials to support the topic, after the study we evaluated the various information that has been gathered. Although our paper describe the detail study, objectives behind the study, outcomes conclusion of clinical study. In our study are found that How the drug comes in the market and what are the various phases through which the drug has to cross. In our study we also understood that without the involvement of animals clinical trials won't be further conducted Through graphs one can easily understand the overviews of clinical trials study. Other supportive points like. Types of clinical trials Significance Rate of pharmacist in clinical trials Have been highlighted to support our article.

A Review on Mitochondrial Dysfunction and Oxidative stress due to Complex-Ⅰ in Parkinson Disease

Parkinson’s disease (PD) is the common physical movement disorder, and it is 2nd most progressive widespread neurodegenerative disorder all over the world, and it is reported that and essential 10 million, over 0.3 % of the total world population. A thoughtful reduction of the neurotransmitter dopamine (DA) in the striatum is the main cause of these motor symptoms, collectively known as parkinsonism. Mitochondria serves as most important organelle in most of the cells and are essential for life and it is also called as heart for all cellular metabolisms. The main and most important role of mitochondria is generation of ATP via oxidative phosphorylation. In this study will study about how complex Ⅰ deficiency effects the mitochondrial and oxidative stress and reactive oxygen species which cause mitochondrial dysfunction and we also study emerging therapies for Parkinson disease with the help of coenzyme Q10 and some genes like FUN-14, FUNDC-1 and dimethyl fumarate or BG-12 in some phases of clinical trials and also by cell transplantation therapy and in future this study helps in finding how this sporadic Parkinson disease occurs in parkinsonism.

A Decisive Review to Understand the Basic Fundamentals of Novel Corona Viruse Disease

With the development and spread of 2019 novel coronavirus (2019-nCoV), also known as the severe acute respiratory syndrome coronavirus 2, a new public health disaster is threatening the world (SARS-CoV-2). In December 2019, the virus was discovered in bats and transmitted to humans via unidentified intermediary species in Wuhan, Hubei Province, China. To date (05/03/2020), there have been roughly 96,000 recorded cases of coronavirus disease 2019 (COVID-2019) and 3300 documented deaths. The disease is spread through inhalation or contact with contaminated droplets, with a 2 to 14-day incubation period. Fever, cough, sore throat, dyspnea, weariness, and malaise are common symptoms. The disease is mild in most people; in some (usually the elderly and those with comorbidities), it can lead to pneumonia, ARDS (acute respiratory distress syndrome), and multi-organ failure. A large number of persons are asymptomatic. The case fatality rate is expected to be between 2 and 3%. Specimen collection, assay collection, serology, nucleic acid testing or molecular testing, and target selection for RT-PCR are all examples of laboratory diagnosis. Home isolation of suspected cases and those with mild illnesses, as well as tight infection control measures in hospitals, including contact and droplet precautions, are all part of the prevention strategy. The virus has a lower fatality rate than its two ancestors, SARS-CoV and Middle East respiratory sickness coronavirus (MERS-CoV). The global consequences of this new epidemic are still unknown.

Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study

This paper presents the results of Demographic and Participation Details of Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For that data of 50 participants was collected using self-administered questionnaire. After ethics approval, data were collected between between Jul-21 and Aug-21 from Gujarat state of India. Results of demographic and participation details are tabulated by its frequency and percentage. Participants are participating more whose age range were 18-41 years, income less than one lakh, education below Higher Secondary and having private job or wage-earner. Age of first time participation was found in range of 18-41 years and frequency of number studies in which participant participated were found from 01 to 20 studies. Also Chi-Square results suggested there is significant (p < 0.05) relation (I) between the Education and Age of first time participation (II) between the occupation and number of times participated.

Basic Concepts of Sterilization Techniques

Sterilization, which is any process, physical or chemical, that destroys all forms of life, it is used especially to destroy microorganisms, spores, and viruses. Precisely defined, sterilization is the complete destruction of all microorganisms by a suitable chemical agent or by heat, either wet steam. In this review, we discussed about various suitable techniques that used for removing of infectious agents. The heat sterilization can be applied only to the thermostable products, and chemical sterilization is also used for any types of plastic or glass materials that degrade with heat. The Gas sterilization involves exposing equipment to chemical gases in an enclosed heated or pressurized chamber.

Pharmacognostical, Phytochemical and Anti-Parkinson’s profile of Mucuna pruriens

Mucuna pruriens is a recognized herbal drug which contains numerous pharmacological activities. Mucuna pruriens commonly known as cow-age or cowitch or velvet bean or Alkushi. Mucuna pruriens has been traditionally used as a food source in a number of countries. It belongs to the Mucuna genus of Fabaceae family and it is cultivated in Asia, America, Africa, and the Pacific Islands. Mucuna pruriens is used in India since 1500 B.C. it contains various important phytoconstituents which are for medicinal purposes. Pods of Mucuna pruriens are used as a vegetable for human consumption. Its fresh leaves are used as animal fodder. Mucuna contains various species, 130 species of Mucuna are metioned in this review. The present review is an attempt to provide all the reported details of information regarding to the Pharmacognostical, Phytochemical and Anti-Parkinson’s Profile of Mucuna pruriens.