Jaya PRAKASH Veluchuri

Jaya PRAKASH Veluchuri
Shri Vishnu College of Pharmacy · Department of Pharmaceutical regulatory affairs

Master of Pharmacy

About

6
Publications
7,955
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2
Citations
Citations since 2016
6 Research Items
0 Citations
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Introduction
Regulatory affairs professional

Publications

Publications (6)
Article
Full-text available
Human challenge trials are studies in which participants are deliberately exposed to a particular infection-causing organism (whether or not they have been vaccinated). Human challenge studies are an important part of a lot of current research, particularly when it comes to vaccine development. While human challenge trials aren't new, but they're t...
Article
Full-text available
In Europe there are very high expectations regarding the quality, safety, and efficacy of medical devices. But in reality, it fails, due to many scandals that threatened the lives of thousands of people. So, the EU has introduced the new regulations in medical devices to meet the expectations. The old directives such as medical device directive (MD...
Article
Full-text available
The present study aims to compare the pharmaceutical equivalence of the same Losartan potassium tablets of different brand manufacturers that are available in the drug market. Three brands of commercial available Losartan potassium film tablets containing 25 mg of Losartan potassium were used in this study. Quality control tests were evaluated for...
Article
Full-text available
The goal of this study is to understand differences in regulatory requirements, bio-equivalence data, drug registration, approval process and, guidelines associated with the generic drug filing in the USA, India, and China and also provide enough information for the drug safety and efficacy in humans. Generic drugs are identical, indistinguishable...
Article
Full-text available
Due to the lack of sound approval process for medical devices in the EU people are suffered from many side effects. Some of the case studies which reflected mainly for the transformation of medical device regulations are PIP implants, MOM hip implants, COSTAR drug-eluting stent, and pleural seal, etc. To reflect the progress over the last 20 years,...
Article
Full-text available
Every year drug recalls occurs routinely. The product recall is resorted to if there is evidence that the use and the continued presence of a batch of a product on the market presents a risk to the health of the user or a local regulatory authority directs a recall. A company must, therefore, have a system for speedy and efficient removal of unsati...

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