Written by a well-known lecturer and consultant to thepharmaceutical industry, this book focuses on the pharmaceuticalnon-statistician working within a very strict regulatoryenvironment. Statistical Thinking for Clinical Trials inDrug Regulation presents the concepts and statisticalthinking behind medical studies with a direct connection to theregulatory environment so that readers can be clear where thestatistical methodology fits in with industry requirements.Pharmaceutical-related examples are used throughout to set theinformation in context. As a result, this book provides adetailed overview of the statistical aspects of the design,conduct, analysis and presentation of data from clinical trialswithin drug regulation. Statistical Thinking for Clinical Trials in DrugRegulation: Assists pharmaceutical personnel in communicating effectivelywith statisticians using statistical language Improves the ability to read and understand statisticalmethodology in papers and reports and to critically appraisethat methodology Helps to understand the statistical aspects of the regulatoryframework better quoting extensively from regulatory guidelinesissued by the EMEA (European Medicines Evaluation Agency), ICH(International Committee on Harmonization and the FDA (Food andDrug Administration)
New Methodologies and Evolving Regulatory Landscapes
Author: J. Rick Turner
At a time when the field of cardiac safety is going through important changes, this unique book provides the rationale for, and cutting-edge explanations of, new regulatory landscapes that will likely govern cardiac safety assessments globally for the foreseeable future. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitro Proarrhythmia Assay initiative is well under way. Developments in the field of cardiovascular safety are also described and discussed in the book. These include the search for more efficient ways to exonerate new drugs for type 2 diabetes from an unacceptable cardiovascular liability, how best to address off-target blood pressure increases induced by noncardiovascular drugs, and the continued evolution of the discipline of Cardio-oncology. “a resource that will likely serve as a standard for years to come” - Dr Jonathan Seltzer Therapeutic Innovation & Regulatory Science, 2017;51(2):180 “I have no hesitation in recommending this book as a valuable reference source” - Dr Rashmi Shah Journal for Clinical Studies, 2017;9(1):62-63
يعد مسار هذه الرواية بالتحديد أكثر تعقيدًا من غيرها، فقد طرحت شِلي فيها أفكارًا جريئة جديدة بالنسبة لعصرها عن الإبداع عندما يتخطى حدود الطبيعة، وقد تعاظَم هذا المسار واستقلَّ بشكلٍ ما عن الرواية نفسها، وصار في حَدّ ذاته نوعًا من المجاز والأسطورة شَقّ لنفسه طريقًا في الفنون الأخرى مثل السينما والمسرح والكاريكاتور والكومِكس، وصار اسم فرانكنشتاين مُرادِفًا لكل إبداع عندما يصير هوسًا يَجلِب عواقب وخيمة على المُبدِع والعالم، ومرادفًا للوحشيَّة وقد تحرَّرَت من عِقالها.
For the first time, a 60-person team of internationally renowned editors and authors presents a textbook of osteopathic medicine that is oriented towards clinical symptoms. Introductory chapters on history, philosophy and the spread of osteopathy are followed by a presentation of its scientific basis that clearly demonstrates how firmly osteopathy is rooted in science. Further chapters cover osteopathic research, diagnosis and principles of treatment. Two parts on therapeutic strategies in osteopathic practice form the core of this book. The first is divided into regions of the body, the second into clinical specialties that offer opportunities for osteopathic treatment. In both clinical parts, osteopathic therapy is presented in the entirety in which it is actually practiced - without the common but artificial separation of parietal, visceral and craniosacral treatment. First, the clinical symptom is explained from a medical perspective, then the osteopathic perspective and and treatment is presented. Thus, the title is not only suitable for conveying a profound understanding of osteopaths in training, be they doctors or non-medical practitioners, but also as a clinical reference of osteopathic medicine for everyday treatment.