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342 results on '"Crommelin, D.J.A."'

5. Contributors

Author

Adler-Moore, J.P., primary, Allen, T., additional, Alving, C., additional, Arkema, A., additional, Bakker-Woudenberg, I.A.J.M., additional, Bally, M.B., additional, Bangham, A., additional, Barenholz, Y., additional, Barois, N., additional, Beissinger, R., additional, Benz, C.C., additional, Bhattacharya, S., additional, Colbern, G., additional, Crommelin, D.J.A., additional, Cullis, P.R., additional, Daemen, T., additional, De Haan, A., additional, Donovan, D., additional, Düzgüneş, N., additional, Fareed, J., additional, Fidler, I.J., additional, Forssen, E.A., additional, Freitag, J., additional, Gabizon, A., additional, Glück, R., additional, Goren, D., additional, Gregoriadis, G., additional, Hansen, C.B., additional, Hong, K., additional, Huang, L., additional, Janoff, A.S., additional, Jato, J., additional, Kirpotin, D., additional, Kleinerman, E.S., additional, Lasic, D.D., additional, Leserman, L., additional, Lieb, L., additional, Lopez-Berestein, G., additional, McCormack, B., additional, McCormick, D., additional, Martin, F.J., additional, Mayer, L.D., additional, Meyer, O., additional, Nicolau, C., additional, Papahadjopoulos, D., additional, Park, J., additional, Perez-Soler, R., additional, Perríe, Y., additional, Proffitt, R.T., additional, Rao, M., additional, Ruff, D., additional, Saffie, R., additional, Schmidt, P.G., additional, Schreier, H., additional, Senior, J., additional, Shankey, V., additional, Shao, Y., additional, Sherwood, R., additional, Sternberg, B., additional, Stuart, D.D., additional, Swenson, C.E., additional, Torchilin, V.P., additional, Uster, P., additional, Vaage, J., additional, van Etten, E.W.M., additional, van Winden, E.C.A., additional, Wasan, K.M., additional, Wegmann, A., additional, Weiner, N., additional, Wilschut, J., additional, Woodle, M., additional, Worth, L.L., additional, Working, P., additional, Zheng, S., additional, Zheng, W., additional, Zou, Y., additional, and Zuidam, N.J., additional

Published
1998
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10. Stabilization

Author

Talsma, H. and Crommelin, D.J.A.

Subjects
Liposomes -- Research, Drug delivery systems -- Research, Drug stability -- Research, Freeze-drying -- Research, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Published
1993

11. Liposomes as drug delivery systems, part 1: Preparation

Author

Talsma, H. and Crommelin, D.J.A.

Subjects
Liposomes -- Usage, Drugs -- Vehicles, Pharmaceutical research -- Analysis, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Published
1992

17. The therapeutic equivalence of complex drugs

Author

Schellekens, H., Klinger, E., Muehlebach, S., Brin, J-F., Storm, G., Crommelin, D.J.A., Advanced drug delivery systems/drug targeting, Innovation Studies, Pharmaceutics, Dep Farmaceutische wetenschappen, Sub Drug targeting, and Sub Drug delivery

Subjects
Drug, Sucrose, Pharmaceutical equivalence, media_common.quotation_subject, Pharmacology, Bioequivalence, Biomedische technologie en medicijnen, Toxicology, Ferric Compounds, Risk Assessment, Patents as Topic, Farmacie/Biofarmaceutische wetenschappen (FARM), Glucaric Acid, Pharmacokinetics, Medical technology, Drugs, Generic, Humans, Medicine, Therapeutic equivalence, media_common, Ferric Oxide, Saccharated, Biological Products, Evidence-Based Medicine, business.industry, Farmacie(FARM), Anticoagulants, Proteins, Biosimilar, Glatiramer Acetate, General Medicine, Congresses as Topic, Heparin, Low-Molecular-Weight, Legislation, Drug, Small molecule, Clinical trial, Therapeutic Equivalency, Risk analysis (engineering), Consumer Product Safety, Liposomes, Hematinics, Peptides, business, Immunosuppressive Agents
Abstract

When the patent of a small molecule drug expires generics may be introduced. They are considered therapeutically equivalent once pharmaceutical equivalence (i.e. identical active substances) and bioequivalence (i.e. comparable pharmacokinetics) have been established in a cross-over volunteer study. However this generic paradigm cannot be applied to complex drugs as biologics and a number of other therapeutic modalities. For copies of biologics the European Medicine Agency and other regulatory agencies have introduced a new regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. However for other complex drugs such as the iron-carbohydrate drugs, low molecular weight heparins (LMWHs), liposomal drugs and the glatiramoids regulatory guidance is still mostly lacking. In this paper we will discuss (therapeutic) experience obtained so far with these different classes of 'complex drugs' and their specifics to provide scientific arguments and criteria for consideration for a regulatory framework for the market authorization for these type of drugs.

Published
2011

18. Liposomes as drug delivery systems: characterization

Author

Talsma, H. and Crommelin, D.J.A.

Subjects
Liposomes -- Health aspects, Drug delivery systems -- Innovations, Drugs -- Vehicles, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Published
1992

19. Subcutaneous administration of superoxide dismutase entrapped in long circulating liposomes. In vivo fate and therapeutic activity in an inflammation model

Author

Corvo, M.L., Boerman, O.C., Oyen, W.J.G., Jorge, J.C.S., Cruz, M.E., Crommelin, D.J.A., and Storm, G.

Subjects
Development of radiopharmaceuticals for diagnosis and therapy of pathological processes, Ontwikkeling van radiofarmaca ten behoeve van diagnose en behandeling van ziekteprocessen
Abstract

Item does not contain fulltext

Published
2000

20. Detecting infection and inflammation with technetium-99m-labeled stealth liposomes

Author

Oyen, W.J.G., Boerman, O.C., Storm, G., Bloois, L. van, Koenders, E.B., Claessens, R.A.M.J., Perenboom, R.M., Crommelin, D.J.A., Meer, J.W.M. van der, and Corstens, F.H.M.

Subjects
Fever of unknown origin, Febris e causa ignota, Scintigrafische detectie van infecties en ontstekingen met radioaktief gelabelde PEG-liposomen, Scintigraphic detection of infection and inflammation with radiolabeled PEG-liposomes, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries)
Abstract

Contains fulltext : 4843.pdf (Publisher’s version ) (Open Access)

Published
1996

21. Conformation and intermolecular interactions of SA2 peptides self-assembled into vesicles

Author

van Hell, A.J., Klymchenko, A., Burgers, P.P., Moret, E.E., Jiskoot, W., Hennink, W.E., Crommelin, D.J.A., Mastrobattista, E., Advanced drug delivery systems/drug targeting, Biofysisch, Biomolecular Mass Spectrometry and Proteomics, Medicinal Chemistry and Chemical Biology, Molecular Pharmacy, Pharmaceutics, Dep Farmaceutische wetenschappen, Sub Biomol.Mass Spect. and Proteomics, Sub Medicinal Chemistry & Chemical biol., Faculteit Betawetenschappen, Sub Drug targeting, and Sub Drug delivery

Subjects
Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Abstract

Previously we have shown that the recombinantly produced SA2 amphiphilic oligopeptide (Ac-Ala-Ala-Val-Val-Leu-Leu-Leu-Trp-Glu-Glu-COOH) self-assembles into nanovesicles (van Hell et al. 2007). In this study, the intermolecular interactions that contribute to the formation of such peptide vesicles are examined. First, analysis of a 3-hydroxyflavone fluorescent probe inserted into the peptide assemblies demonstrated that the peptide self-assembly is based on hydrophobic clustering. The polarity of this hydrophobic microenvironment was comparable to that of negatively charged lipid bilayers. A substantial level of hydration at the hydrophilic-hydrophobic interface was detected, as was further confirmed by tryptophan fluorescence analysis. However, organic solvents such as acetonitrile, tetrahydrofuran, or ethanol could not disrupt SA2 oligopeptide vesicles, whereas these solvents fully disintegrated lipid vesicles. Instead, the SA2 assembly immediately disintegrated in hydrogen breaking solvents such dimethylsulfoxide and dimethylformamide, suggesting the involvement of additional intermolecular interactions via hydrogen bonding. Circular dichroism and Fourier transform infrared spectroscopy excluded well-defined patterns of intramolecular hydrogen bonding and indicated the polyproline type II as the dominant SA2 peptide conformation, which enables intermolecular hydrogen bonding. All-atom computational simulations were used to confirm the presence of such intermolecular hydrogen bonds and degrees of hydration. On the basis of the experimental and computational data presented, we propose a model of an interdigitated peptide assembly that involves intermolecular hydrogen bonding in addition to hydrophobic interactions that stabilize SA2 oligopeptide vesicles.

Published
2010

22. Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

Author

Carpenter, J.F., Randolph, T.W., Jiskoot, W., Crommelin, D.J.A., Middaugh, C.R., Winter, G., Fan, Y.X., Kirshner, S., Verthelyi, D., Kozlowski, S., Clouse, K.A., Swann, P.G., Rosenberg, A., Cherney, B., Advanced drug delivery systems/drug targeting, and Dep Farmaceutische wetenschappen

Subjects
Farmacie/Biofarmaceutische wetenschappen (FARM), Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2009

23. Commentary: 'A systems view on the future of medicine: Inspiration from Chinese medicine?'

Author

Verpoorte, R., Crommelin, D.J.A., Danhof, M., Gilissen, L.J., Schuitmaker, H., van der Greef, H.J., Witkamp, R.F., Advanced drug delivery systems/drug targeting, and Dep Farmaceutische wetenschappen

Subjects
Farmacie/Biofarmaceutische wetenschappen (FARM), Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2009

24. The pharmaceutical sciences in 2020-Report of a conference organized by the Board of Pharmaceutical Sciences Federation (FIP)

Author

Shah, V.P., Besanc, L.J.R., Stolk, P., Tucker, G., Crommelin, D.J.A., Advanced drug delivery systems/drug targeting, Population-based studies of drug treatment: from molecule to patient outcomes, and Dep Farmaceutische wetenschappen

Subjects
Farmacie/Biofarmaceutische wetenschappen (FARM), Ziekenhuisstructuur en organisatie van de gezondheidszorg, Pharmacology, Epidemiology, Medical technology, Farmacie(FARM), Public Health, Biomedische technologie en medicijnen
Published
2009

33. Cellular uptake of cationic polymer-DNA complexes via caveolae plays a pivotal role in gene transfection in COS-7 cells

Author

van der Aa, M.A.E.M., Huth, U.S., Häfele, S.Y., Schubert, R., Oosting, R.S., Mastrobattista, E., Hennink, W.E., Peschka-Süss, R., Koning, G.A., Crommelin, D.J.A., Advanced drug delivery systems/drug targeting, Dierexperimenteel, and Dep Farmaceutische wetenschappen

Subjects
Farmacie/Biofarmaceutische wetenschappen (FARM), Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2007

34. Artificial viruses: a nanotechnological approach to gene delivery

Author

Mastrobattista, E., van der Aa, M.A.E.M., Hennink, W.E., Crommelin, D.J.A., Advanced drug delivery systems/drug targeting, and Dep Farmaceutische wetenschappen

Subjects
Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2006

37. Modelling the release of proteins from degrading dextran microspheres using kinetic Monte Carlo simulations

Author

Vlugt-Wensink, K.D.F., Vlugt, T.J.H., Jiskoot, W., Crommelin, D.J.A., Verrijk, R., Hennink, W.E., Advanced drug delivery systems/drug targeting, Chemie van de vaste stof: Luminescentie en elektrochemie, Grensvlakken, Dep Farmaceutische wetenschappen, and Dep Scheikunde

Subjects
Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2006

38. In vitro degradation behavior of microspheres based on cross-linked dextran

Author

Vlugt-Wensink, K.D.F., Jiang, X., Schotman, G., Kruijtzer, G., Vredenberg, A., Chung, J.T., Zhang, Z., Versluis, C., Ramos, D., Verrijk, R., Jiskoot, W., Crommelin, D.J.A., Hennink, W.E., Advanced drug delivery systems/drug targeting, Biomoleculaire Massaspectrometrie, Massaspectrometrie, Dep Farmaceutische wetenschappen, and Dep Scheikunde

Subjects
Farmacie/Biofarmaceutische wetenschappen (FARM), Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2006

39. The nuclear pore complex: the gateway to successful nonviral gene delivery

Author

van der Aa, M.A.E.M., Mastrobattista, E., Oosting, R.S., Hennink, W.E., Koning, G.A., Crommelin, D.J.A., Advanced drug delivery systems/drug targeting, Dierexperimenteel, and Dep Farmaceutische wetenschappen

Subjects
Pharmacology, International, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2006

42. Identification of formaldehyde-induced modifications in proteins: reactions with insulin

Author

Metz, B., Kersten, G.F.A., Baart, G.J.E., de Jong, A., Meiring, H.D., ten Hove, J., van Steenbergen, M.J., Hennink, W.E., Crommelin, D.J.A., Jiskoot, W., Advanced drug delivery systems/drug targeting, and Dep Farmaceutische wetenschappen

Subjects
Pharmacology, Medical technology, Farmacie(FARM), Biomedische technologie en medicijnen
Published
2006

44. Equivalence of glatiramer acetate products: challenges in assessing pharmaceutical equivalence and critical clinical performance attributes

Author

Borchard, G and Crommelin, D.J.A

Abstract

ABSTRACTIntroduction: This review discusses the challenges to characterize and evaluate the peptide based drug glatiramer acetate (GA) and its follow-on products used for treatment of multiple sclerosis patients.Areas covered: GA is a highly complex mixture of peptides consisting of four amino acids. The various (physico)-chemical approaches and bioassays used for characterizing this complex drug product are described. It is not possible to link data from preclinical performance to outcomes observed in clinical trials as no critical attributes suitable for predicting the clinical performance in MS patients have been identified yet. The limited insight into the precise mechanism(s) of action of GA may explain why these critical clinical performance attributes still have not been identified.Expert opinion: The complexity of GA and lack of understanding of critical clinical performance attributes leads to a number of issues to be resolved as they hamper industry and regulatory bodies in designing and evaluating follow-on/generic applications of GA. The following questions are waiting to be addressed: Preclinical characterization vs clinical outcome: what is the relation? What are possible biomarkers? How to choose the right patient group? What is the experience with existing follow-on versions? Is there a place for GA ‘betters’? How to evaluate existing and draft new guidance documents and pharmacopoeial monographs?

Published
2018
Full Text
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45. The therapeutic equivalence of complex drugs

Author

Advanced drug delivery systems/drug targeting, Innovation Studies, Pharmaceutics, Dep Farmaceutische wetenschappen, Sub Drug targeting, Sub Drug delivery, Schellekens, H., Klinger, E., Muehlebach, S., Brin, J-F., Storm, G., Crommelin, D.J.A., Advanced drug delivery systems/drug targeting, Innovation Studies, Pharmaceutics, Dep Farmaceutische wetenschappen, Sub Drug targeting, Sub Drug delivery, Schellekens, H., Klinger, E., Muehlebach, S., Brin, J-F., Storm, G., and Crommelin, D.J.A.

Published
2011

46. Thiolated recombinant human tumor necrosis factor-Alpha protects against Plasmodium berghei K173-induced experimental cerebral malaria in mice

Author

Postma, N.S., Hermsen, C.C., Crommelin, D.J.A., Eling, W.M.C., and Zuidema, J.

Subjects
gastheer-parasiet interactie [Malaria], parasite-host interaction [Malaria]
Abstract

Item does not contain fulltext 'The introduction of reactive thiol groups in recombinant human tumor necrosis factor (TNF) alpha (rhTNF-alpha) by the reagent succinimidyl-S-acetylthioacetate resulted in the formation of a chemically stabilized rhTNF-alpha trimer (rhTNFalpha-AT; as determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis imental murine cerebral malaria (ECM) after itnravenous injection compared to the protective efficacy of nonmodified rhTNF-alpha. Administration of thiolated rhTNF-alpha with protected thiol groups (rhTNFalpha-ATA; no stabilized trimer in vitro) exhibited the same protective efficacy against ECM, while in vitro bioactivity was reduced. Parasitemia was significantly suppressed in rhTNF-treated mice that were protected against ECM but not in treated mice that developed ECM. Protection against ECM was not related to increased concentrations in plasma of soluble TNF receptor 1 and 2 directly after injection or at the moment of development of ECM in nontreated mice. The results indicate that thiolation of rhTNF-alpha leads to the formation of stable trimers with increased potential in vivo.

Published
1999

48. Intravenous administration of superoxide dismutase entrapped in long circulating liposomes. II. In vivo fate in a rat model of adjuvant arthritis

Author

Corvo, M.L., Boerman, O.C., Oyen, W.J.G., Bloois, L. van, Cruz, M.E., Crommelin, D.J.A., and Storm, G.

Subjects
Scintigrafische detectie van infecties en ontstekingen met radioaktief gelabelde PEG-liposomen, Scintigraphic detection of infection and inflammation with radiolabeled PEG-liposomes
Abstract

Item does not contain fulltext

Published
1999

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