Clinical Research in Pharmaceutical Drug Development

2021 ◽  
pp. 417-434
Author(s):  
Srinivas Ghatta ◽  
Michelle Niewood
Keyword(s):  
Drug Development ◽  
Clinical Research ◽  
Pharmaceutical Drug

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

Drug-induced cardiac toxicity: emphasizing the role of electrocardiography in clinical research and drug development

2004 ◽  
Vol 37 (1) ◽  
pp. 19-24 ◽  
Author(s):  
Ihor Gussak ◽  
Jeffrey Litwin ◽  
Robert Kleiman ◽  
Scott Grisanti ◽  
Joel Morganroth
Keyword(s):  
Drug Development ◽  
Clinical Research ◽  
Cardiac Toxicity ◽  
Drug Induced

scholarly journals Artificial intelligence in clinical research

2016 ◽  
Vol 3 (4) ◽  
pp. 187 ◽  
Author(s):  
Veerabhadra Sanekal Nayak ◽  
Mohammed Saleem Khan ◽  
Bharat Kumar Shukla ◽  
Pranjal R. Chaturvedi
Keyword(s):  
Artificial Intelligence ◽  
Clinical Trials ◽  
Survival Rate ◽  
Drug Development ◽  
Clinical Research ◽  
Business Sector ◽  
Planning Phase ◽  
Pancreatic Malignancy ◽  
Present Technique ◽  
Critical Interest

<p>Envision dedicating fifteen years to a critical interest and emptying staggering amount of funds into it, at the same time confronting a disappointment rate of 95 percent. That is the crippling reality for pharmaceutical organizations, which toss billions of dollars consistently toward medications that possible won't work – and after that do a reversal to the planning phase and do it once more. Today's medications go to the business sector after an extensive, very costly process of drug development. It takes anywhere in the range of 10 to 15 years, here and there significantly more, to convey a medication from introductory revelation to the hands of patients – and that voyage can cost billions up to 12 billion, to be correct. That is just a lot to spend, and excessively yearn for patients to hold up. Patients can hardly wait 15 years for a lifesaving drug, we require another productive focused on medication revelation and improvement process. Artificial Intelligence, can significantly reduce the time included, and also cut the expenses by more than half. This is made conceivable through a totally distinctive way to deal with medication revelation. With the present technique, for each 100 medications that achieve first stage clinical trials, only one goes ahead to wind up a genuine treatment. That is stand out percent, it's an unsustainable model, particularly when there are ailments, for example, pancreatic malignancy which has a normal five-year survival rate of 6%.</p>

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