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Introduction to Biotechnology Operations: Planning for Success
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Contraindication refers to those times when the team recommends that the product simply should not be used, when it might be unsafe, for example. Basic contraindications should be considered, and here again it might be helpful to consult a physician with experience of treating the disease in the indicated patient population. Warnings and precautions, on the other hand, are more difficult to define at this very early stage of development and in the absence of any safety information on the product. However, warnings and precautions from products similar in nature, treatment indication, and target patient populations may be instructive as to what may or may not be acceptable for this product. The contraindications, warnings, and precautions often narrow the indication, and this is important information to consider in product development. For the peptide used to treat hypertension, it might be contraindicated to use the drug in patients with certain other cardiovascular diseases as known from experience in cardiovascular medicine and pharmacology of similar products. The malaria vaccine might be contraindicated when the patient was already infected with the parasite. The remedial bacterium might be contraindicated when other petrochemicals, such as gasoline or diesel fuel, were present. The drought-resistant soybean plant might not be used within a kilometer of other soybean fields. The main point is that a knowledgeable product development team confronts these issues during the process of developing a TPP and well before development begins. This facilitates early planning to resolve, if possible, each potential problem or issue.
Effects of the Nordic Hamstring exercise on sprint capacity in male football players: a randomized controlled trial
Published in Journal of Sports Sciences, 2018
Lasse Ishøi, Per Hölmich, Per Aagaard, Kristian Thorborg, Thomas Bandholm, Andreas Serner
The NHE is an on-field partner-assisted eccentric hamstring exercise, which increases eccentric hamstring strength (Mjolsnes, Arnason, Osthagen, Raastad, & Bahr, 2004) and BFlh fascicle lengths (Bourne et al., 2017). Consequently, the progressive 10-week NHE protocol introduced by Mjolsnes et al. (2004) effectively reduces the incidence of HSIs in football (Petersen, Thorborg, Nielsen, Budtz-Jorgensen, & Holmich, 2011). Despite the high quality evidence of the effectiveness of the NHE to reduce HSIs, implementation of the exercise in elite football remains limited (Bahr, Thorborg, & Ekstrand, 2015). This could be due to sports medicine and coaching professionals labelling the NHE as ineffective (Ekstrand, Hagglund, Kristenson, Magnusson, & Walden, 2013) or even “contraindicated” (Gambetta & Benton, 2006) in relation to injury prevention and performance, respectively.