Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market […]
Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-parameter: i) Germany’s federal drug database […]
Abstract: Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index drugs and the indiscriminate use of biosimilars. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generic substitution. The guidelines […]
