Нозологии и группы препаратов

Анальгетические препараты (коды АТХ: N02, M01-03)

FDA Guidance «Analgesic Indications: Developing Drug and Biological Products», 2014

European Medicines Agency «Guideline on the clinical development of medicinal products intended for the treatment of pain», 2017

Кардиологические препараты (коды АТХ: C01-C10)

ICH E12A: Principles for clinical evaluation of new antihypertensive drugs, 2000

European Medicines Agency «Guideline on clinical investigation of medicinal products in the treatment of hypertension», 2017

European Medicines Agency «Guideline on clinical investigation of medicinal products in the treatment of lipid disorders», 2017

European Medicines Agency «Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension», 2010

European Medicines Agency «Note for guidance on antiarrhythmics», 1996

European Medicines Agency «Addendum to the Guideline on antiarrhythmics on atrial fibrillation and atrial flutter», 2011

European Medicines Agency «Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation», 2014

European Medicines Agency «ICH E14: Note for guidance on the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs», 2005

European Medicines Agency «ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answers», 2016

European Medicines Agency «Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients (formerly CPMP/EWP/6235/04)», 2017

European Medicines Agency «Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery», 2010

European Medicines Agency «Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease», 2016

European Medicines Agency «Guideline on clinical investigation of medicinal products for the treatment of acute heart failure», 2015

European Medicines Agency «Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure», 2018

European Medicines Agency «Guideline on the clinical investigation of anti-anginal medicinal products in stable angina pectoris», 2006

European Medicines Agency «Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome», 2018

European Medicines Agency « Note for guidance on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease», 2002

European Medicines Agency «Guideline on the evaluation of medicinal products for cardiovascular disease prevention», 2009

European Medicines Agency «Questions and answers document on the clinical development of fixed combinations of drugs belonging to different therapeutic classes in the field of cardiovascular treatment and prevention», 2005