18 results
Search Results
2. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
3. Human albumin and 6% hydroxyethyl starches (130/0.4) in cardiac surgery: a meta-analysis revisited
4. Traditional use of medicinal plants in Jablanica district (South-Eastern Serbia): ethnobotanical survey and comparison with scientific data
5. A Disability Bioethics Reading of the FDA and EMA Evaluations on the Marketing Authorisation of Growth Hormone for Idiopathic Short Stature Children
6. Medicinal products for geriatric patients in Germany: Current status of regulatory requirements and clinical reality
7. Clinical evidence supporting the marketing authorization of biosimilars in Europe
8. Neue Konzepte der Zulassung von Onkologika jenseits randomisierter klinischer Studien
9. European Regulatory Developments for Orally Inhaled and Nasal Drug Products
10. Medicines for older people: assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products
11. A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs
12. International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies
13. Inflation of Type I Error in the Evaluation of Scaled Average Bioequivalence, and a Method for its Control
14. Commentary on the draft revised guideline on the environmental risk assessment of medicinal products for human use
15. Biosimilars in der Rheumatologie: Entwicklung und Ergebnisse klinischer Studien
16. Regulatorische Aspekte zu Biosimilars: Mythen und Fakten
17. The use of 2D fingerprint methods to support the assessment of structural similarity in orphan drug legislation
18. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008–2012)
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