Introduction: A new drug development process starts with animal testing, before it is been tested in humans. These animal studies are designed to ensure that the drug is effective and safe in animals. Moreover, the results obtained should be reproducible. But even the reproducible results on animal studies cannot provide relevant prediction of the safe and effectiveness of a new drug. Scientists often stipulate the structural and physiological similarities between human and animals as a reason…

Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should…

Hunter Larson Prof. Barbara Roark PLS 130 1 July 2015 The FDA’s Drug Approval Process: History, Pre-Market, and Post-Market I. Introduction The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit…

The drug approval process is a complicated labyrinth that sometimes seems impossible to navigate. There are guidelines, protocols, procedures and standards that each person in the process are expected to follow. This includes the doctors, principle investigators, researchers, pharmaceutical companies, the regulatory bodies and yes, the patients. The patients are by far the most important aspect of a clinical trial and obtaining drug approval. Without the willing volunteers in clinical trials there…

of product development report, it is not still clear to ANDA sponsors how this actually applies. As a result, more internal meetings and discussions between the sponsors and the FDA delays the product approval. One of the ways to overcome these challenges is to have a product development report with verified and justified specifications based on the QbD efforts which can help the Office of Generic Drugs (OGD) to be efficient in understanding the developed generic product and approval [14,17].…

Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should…

Hunter Larson Barbara Roark PLS 130 1 July 2015 The FDA’s Drug Approval Process: History, Pre-Market, and Post-Market I. Introduction The Food and Drug Administration is a regulation agency within the Department of Health and Human Services. It’s role in our nation is to be responsible for “protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation”…

Joston Toney Nicole Thompson English 2010 Online 03 December 2016 The FDA Approval Process of Drugs When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my…

Krishna (2008) article, the drug development and approval process is an extensive and costly endeavor. The goal of experimental medicine is to increase the efficiency of drug development by providing a better understanding of the drug’s mechanism(s) of action, dose response, efficacy, and safety, allowing the process to be accelerated for the most promising and efficacious candidates (Krishna, Herman, & Wagner, 2008). Preclinical testing begins with identifying the ideal drug target. The target should…

and controversial decisions. “The FDA just made its most controversial drug approval of the year” (Fortune 2016). This injectable drug is called eteplirsen by Sarepta Therapeutics and it is an exon-skipping drug targeting a section of genetic code called “exon 51” in the dystrophin gene. Exon skipping is a type of strategy that is being developed for the rare disease DMD (Duchenne Muscular Dystrophy). The exon-skipping process skips sections of genetic codes during protein manufacturing, allowing…