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Product Development in Biotechnology
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2020
Once a drug has completed preclinical trials with a great success rate, the drug molecule is now ready for testing in humans, starting with normal and healthy individuals, to check the toxicity or side effects of the drug molecule. If the drug does not show any apparent toxicity or side effects, it may now be tested in patients suffering from specific disease conditions. There are four phases of clinical trials: Phase I, Phase II, Phase III, and Phase IV. All these phases are conducted in specialized and FDA-approved clinical centers and hospitals. In healthcare, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety. Health authority or ethics committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients in small pilot studies initially, followed by larger-scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Placebo and somatization
Published in Herman Staudenmayer, Environmental Illness, 2018
In medicine, placebos are utilized in several ways. First, in clinical pharmacology research, the placebo is used to control for nonspecific effects on bodily states as well as the effects of expectation or suggestion on symptom report during the course of a clinical trial of a new drug. In these experiments, the subjects are informed that placebos are being used and why, but not when, in the course of the study. In a case-control study (different subjects get the active agent or placebo), the effects of expectations are assessed by the magnitude of effects in the placebo group. In cross-over studies, the subjects get both the placebo and the active drug during different phases. The differences in symptom measures between the placebo and the drug periods are used to assess the reliability and the magnitude of the effects of the drug. The crossover design is essential if the number of subjects is small or it is a single-case design (Kazdin, 1976).
Clinical Trials
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
A clinical trial, also referred to as clinical study or clinical research, is the overall process of evaluating the safety and efficacy of a medical product or an intervention in humans. Importantly, it is investigational and the purpose of a clinical trial is to learn about a product and how it impact humans. The intention is not to treat patients but rather to provide data regarding safety and efficacy in humans. Successful completion of several clinical trials is required for market approval of drugs, biologics, and some medical devices by FDA, and hence, clinical studies are used in the biotechnology industry to support market approval of biopharmaceuticals. However, the concepts developed for clinical studies incorporate scientific and design elements shared with field trials of other biotechnology products for which there is no testing in humans, such as field studies of environmental or agricultural products.
Clinical trial supply chain design based on the Pareto-optimal trade-off between time and cost
Published in IISE Transactions, 2018
Hui Zhao, Kan Wu, Edward Huang
Clinical trials play a key role in the process of developing new drugs. A new drug has to be tested on human beings in order to determine its safety, efficacy, and dose levels before it can be approved by the Food and Drug Administration (FDA). A clinical trial usually includes three phases. A drug that successfully passes all phases receives approval from the FDA and enters the marketplace. The trial is terminated immediately when the drug fails in any phase.