Clinical research manuscripts that comply with international and national standards for such work (such as the Declaration of Helsinki or relevant Governmental regulation e.g. the UK’s The Medicines for Human Use (Clinical Trials) Regulations). Studies which are adequately controlled (be that compare...
Palgrave Macmillan UKCorrigan O: The limitations of current ethical regulations. Regulation of the pharmaceutical industry (Edited by: Abraham J, Lawton SH). Palgrave, Mcmillan 2003, 195–211.Corrigan, O. (2003). The limitations of current ethical regulations. In J. Abraham and H. Lawton Smith...
In this paper the current Food and Drug Administration (FDA) regulations pertaining to the testing of new drugs in the U.S.A. are reviewed and the basic approach to clinical trials for testing the efficacy of drugs is described.The authors consider three phases of a drug trial: (1) the ...
An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units. Trials. 2019;20(1):556. 21. Christina K, Rollinger Y, Sigmund M, Kunert V, Breuer B. RBM – An Update of Experiences Among European CRAs. Applied Clinical Trials. 2017;20 October. 22. Hurley C, ...
Global demand for food is expected to nearly double by 2050. Alternative proteins (AP) have been proposed as a sustainable solution to provide food security as natural resources become more depleted. However, the growth and consumer intake of AP remains
The experiment was approved by the Medical Ethics Committee UZ KU Leuven/Research (S57869) and was performed in accordance with the relevant guidelines and regulations (clinicaltrials.gov registration number NCT03337334, date 08/11/2017). Informed consent to participate in the experiment was obtained...
In organic farming, the use of organic starting material is obligatory according to the current EU regulations. However, sufficient material of high qualit... SPC Groot - Ond 被引量: 0发表: 2007年 PLANT BEEDING FOR ORGANIC FARMING: CURRENT STATUS AND PROBLEMS IN EUROPE In organic farming, th...
Global demand for food is expected to nearly double by 2050. Alternative proteins (AP) have been proposed as a sustainable solution to provide food security as natural resources become more depleted. However, the growth and consumer intake of AP remains
Early data obtained in trials using ASO, siRNA or the CRISPR-Cas9 technology support this interpretation to date; however, the long-term clinical monitoring of this lifelong treatment might reveal additional physiological roles of plasma TTR. References Adams D, Koike H, Slama M, Coelho T. ...
Large simple trials; Pragmatic clinical trials; Observational studies; and Supplements to RCTs. However, there is still controversy as to whether or not RWD/RWE is generated when considering individual examples other than RCTs. For example, data from pragmatic RCTs are considered to be RWD/RWE,...