Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision
暂无分享,去创建一个
Rogério Sá Gaspar | Beatriz Silva-Lima | Fernando Magro | Armando Alcobia | Fernando Leal da Costa | José Feio | R. Gaspar | F. Magro | B. Silva‐Lima | A. Alcobia | F. D. da Costa | J. Feio
[1] H. Leufkens,et al. The EU regulatory landscape of non‐biological complex drugs (NBCDs) follow‐on products: Observations and recommendations , 2019, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[2] S. Mühlebach,et al. Iron Carbohydrate Complexes: Characteristics and Regulatory Challenges , 2015 .
[3] Andrew Webber,et al. Observations and Recommendations , 1980 .
[4] S. Lee,et al. Liposomal Drug Product Development and Quality: Current US Experience and Perspective , 2017, The AAPS Journal.
[5] S. Mühlebach,et al. Medication practice in hospitals: are nanosimilars evaluated and substituted correctly? , 2017, European journal of hospital pharmacy. Science and practice.
[6] William C Zamboni,et al. Animal models for analysis of immunological responses to nanomaterials: Challenges and considerations. , 2018, Advanced drug delivery reviews.
[7] A. Park,et al. CENTER FOR DRUG EVALUATION AND RESEARCH , 2009 .
[8] M. Dobrovolskaia,et al. Addressing barriers to effective cancer immunotherapy with nanotechnology: achievements, challenges, and roadmap to the next generation of nanoimmunotherapeutics. , 2018, Advanced drug delivery reviews.
[9] D. Silverberg,et al. Differences between intravenous iron products: focus on treatment of iron deficiency in chronic heart failure patients , 2019, ESC heart failure.
[10] Susanne Bremer-Hoffmann,et al. Main trends of immune effects triggered by nanomedicines in preclinical studies , 2018, International journal of nanomedicine.
[11] Buket Aksu,et al. Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[12] D. Crommelin,et al. Introduction: Defining the Position of Non-Biological Complex Drugs , 2015 .
[13] K. Shadan,et al. Available online: , 2012 .
[14] Vinod P. Shah,et al. How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider , 2013, The AAPS Journal.
[15] Thierry Bastogne,et al. Quality-by-design of nanopharmaceuticals - a state of the art. , 2017, Nanomedicine : nanotechnology, biology, and medicine.
[16] Gerrit Borchard,et al. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks , 2017, Annals of the New York Academy of Sciences.
[17] J. Nicholas,et al. Clinical development, immunogenicity, and interchangeability of follow-on complex drugs , 2014 .
[18] Arnold G. Vulto,et al. The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead? , 2013 .
[19] E. Simanek,et al. Nanoparticle physicochemical properties determine the activation of intracellular complement. , 2019, Nanomedicine : nanotechnology, biology, and medicine.
[20] Thierry Bastogne,et al. Bridging communities in the field of nanomedicine , 2019, Regulatory toxicology and pharmacology : RTP.
[21] J. Morais,et al. The new European Medicines Agency guideline on the investigation of bioequivalence. , 2010, Basic & clinical pharmacology & toxicology.
[22] Tiziana Di Francesco. Non-Biological Complex Drugs (NBCDs): evaluation of critical quality attributes of iron sucrose and iron polymaltose , 2018 .
[23] Beat Flühmann,et al. How to select a nanosimilar , 2017, Annals of the New York Academy of Sciences.
[24] Jim Nolan,et al. A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products , 2016, The AAPS Journal.
[26] G. Borchard,et al. Nanomedicines in clinical practice: Are colloidal iron sucrose ready‐to‐use intravenous solutions interchangeable? , 2019, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[27] Marina A Dobrovolskaia,et al. Immunological effects of iron oxide nanoparticles and iron-based complex drug formulations: Therapeutic benefits, toxicity, mechanistic insights, and translational considerations. , 2018, Nanomedicine : nanotechnology, biology, and medicine.
[28] C. Grady,et al. Points to consider , 2009 .
[29] Gert Storm,et al. The therapeutic equivalence of complex drugs. , 2011, Regulatory toxicology and pharmacology : RTP.