Jon S. B. de Vlieger

Application of drug metabolising mutants of cytochrome P450 BM3 (CYP102A1) as biocatalysts for the generation of reactive metabolites

Micaela C. Damsten, Barbara M. A. van Vugt‐Lussenburg, Tineke Zeldenthuis et al. · Chemico-Biological Interactions · 2007 · 92 citations

Medicine, Biochemistry, Pharmacology +14

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

L. Hussaarts, Stefan Mühlebach, Vinod P. Shah et al. · Annals of the New York Academy of Sciences · 2017 · 88 citations · Full text

Pharmacy, Biotechnology, Pharmacology +17

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”

Jon S. B. de Vlieger, Daan J.A. Crommelin, Katherine M. Tyner et al. · The AAPS Journal · 2019 · 82 citations · Full text

Pharmacy, Pharmaceutical Policy, Toxicology +16

The similarity question for biologicals and non-biological complex drugs

Daan J.A. Crommelin, Vinod P. Shah, Imre Klebovich et al. · European Journal of Pharmaceutical Sciences · 2015 · 68 citations · Full text

Pharmacy, Pharmacology, Bioequivalence +14

Different Pharmaceutical Products Need Similar Terminology

Daan J.A. Crommelin, Jon S. B. de Vlieger, Vera Weinstein et al. · The AAPS Journal · 2013 · 59 citations · Full text

Medicine, Pharmacology, Pharmaceutical Regulation +2