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Showing posts with the label Clinical Trail Design

Pharmaceutical Legislation On Notice To Applicants And Regulatory Guidelines For Medicinal Products For Human Use | Pepgra

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Notice to Applicants The European Commission in tandem with proficient authorities from the Member States, the European  Medicines Agency along side interested parties created the Notice to Applicants (NTA). This was through with the target to fulfil the obligations of the commission with regards to article 6 of Regulation ( European Union ) No. 726/2004, and with regards to the Annex I to Directive 2001/83/EC as per the amendments. one among the primary editions of the Notice to Applicants (which is volume 2 within the series “The Rules governing medicinal products within the ecu Union) was initially published within the year 1986.  This notice was subject to further revisions following which a completed version was issued i.e., the second edition was published in 1989(European Commision, 2020). Later, during 1993, the processes associated with applications for marketing authorizations were modified and therefore the mutual also as centralized regulation procedures came into...

Difference Between Scientific Writing and Medical Writing | Pepgra.com

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Scientific writing skills involve conveying the necessary information about a technology in various fields of life sciences such as, biotechnology, medicine, and engineering for publication or to explore new ideas to educationalists, scholars, and other professionals. It conveys information on novel innovations and theories which is essential for publishing and marketing academic journals and so on.The purpose of scientific writing companies   is to provide the useful information on a paper to grab the attention of readers and to make them understand the content.  In any situation if the document fails to convey the appropriate information, the reader may not understand the concept which might lead to lose their interest to read (Cristian A. Linte, 2014) . However, every one cannot be a good scientific writer, often it is difficult to put the innovative ideas on paper to document and bring it to the reader.  The poor writing will erode reader’s co...

Clinical Trial Design and Artificial Intelligence | Pepgra.com

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Clinical trials take up the second half of the ten – 15 year, 1.5 – 2.0 billion USD, cycle of development only for introducing a replacement drug within a market. Therefore, any Clinical Trials Services that end in failure tends to translate not just in losses in terms of investment for the clinical trial but also takes into its ambit the prices incurred as preclinical development costs.  This renders the loss for each failed clinical test at 800 million to 1.5 billion USD(Harrer et al., 2019). Keeping these factors in mind, it might be beneficial to explore how AI or AI because it is popularly known are often effectively utilized to re-mould the key phases of a Clinical Trail design with a view to reinforce the speed of success within the trial. Factors causing Failures in Clinical Trials and how AI can help The main two factors that cause failure within clinical trials services pertains to the choice of patient cohorts and therefore the mechanisms used for recrui...