Quality by Design

Discover our publications about the Quality by Design !
This is your chance to know everything about this method

Our vulgarization articles

The Origins – Pharmaceutical Quality by Design

This short and popular article aims to recall the important dates which marked the emergence of the pharmaceutical Quality by Design good practice.

The Economics Stakes – Pharmaceutical Quality by Design

This short article addresses the economic issues of implementing the QbD approach for the development of new drugs.

A Question of Cycles – Pharmaceutical Quality by Design

This short article aims to situate QbD in relation to other quality control approaches by analyzing and comparing their operating cycles.

[1] I. Abdelmomen, M. Vincent, F. Thiebaud, J. Budzinski, T. Bastogne, T. Ben Zineb, and M. Engels- Deutsch, “Experimental Analysis of the Influence of Heat Treatments on the Flexibility of NiTi Alloy for Endodontic Instruments Manufacturing,” Materials, vol. 16, no. 9, p. 3437, 2023.
[2] S. Deneuve, T. Bastogne, M. Duclos, C. Mirjolet, P. Bois, P. Bachmann, L. Nokovitch, P.-E. Roux, D. Girodet, M. Poupart, et al., “Predicting acute severe toxicity for head and neck squamous cell carcinomas by combining dosimetry with a radiosensitivity biomarker: a pilot study,” Tumori Journal, vol. 109, no. 2, pp. 173–185, 2023.
[3] T. Bastogne, “iQbD: a TRL-indexed Quality-by-Design Paradigm for Medical Device Engineering,” Transactions of the ASME, Journal of Medical Devices, vol. 16, June 2022.
[4] T. Bastogne, F. Caputo, A. Prina-Mello, S. Borgos, and M. Barberi-Heyob, “A State of the Art in Analytical Quality-by-Design and Perspectives in Characterization of Nano-enabled Medicinal Products,” Journal of Pharmaceutical and Biomedical Analysis, vol. 219, 2022.
[5] T. Bastogne, L. Hassler, J. Bruniaux, M. Thomassin, X. Gidrol, E. Sulpice, and F. P. Navarro, “A Bayesian implementation of Quality-by-Design for the development of Cationic Nano-Lipid for siRNA Transfection,” IEEE Transactions on NanoBioscience, 2022.
[6] S. Bevers, S. A. Kooijmans, E. Van de Velde, M. J. Evers, S. Seghers, J. J. Gitz-Francois, N. C. van Kronenburg, M. H. Fens, E. Mastrobattista, L. Hassler, et al., “mRNA-LNP vaccines tuned for systemic immunization induce strong antitumor immunity by engaging splenic immune cells,” Molecular Therapy, vol. 30, no. 9, pp. 3078–3094, 2022.
[7] P. Champéroux, R. Fares, T. Bastogne, S. Richard, J.-Y. Le Guennec, and J. Thireau, “Contribution of haemodynamic side effects and associated autonomic reflexes to ventricular arrhythmias triggering by torsadogenic hERG blocking drugs,” British Journal of Pharmacology, vol. 179, no. 18, pp. 4549–4562, 2022.
[8] M. Geoffroy, M. Lemesle, A. Kleinclauss, S. Mazerbourg, L. Batista, M. Barberi-Heyob, T. Bastogne, W. Boireau, A. Rouleau, D. Dupommier, et al., “Ab186 inhibits migration of triple-negative breast cancer cells and interacts with α-tubulin,” International Journal of Molecular Sciences, vol. 23, no. 12, p. 6859, 2022.
[9] J.-P. Jehl, P. Dan, A. Voignier, N. Tran, T. Bastogne, P. Maureira, and F. Cleymand, “Transverse isotropic modelling of left-ventricle passive filling: mechanical characterization for epicardial biomaterial manufacturing,” Journal of the mechanical behavior of biomedical materials, vol. 119, p. 104492, 2021.
[10] P. Guyot, E.-H. Djermoune, B. Chenuel, and T. Bastogne, “A signal demodulation-based method for the early detection of Cheyne-Stokes respiration,” Plos one, vol. 15, no. 3, p. e0221191, 2020.
[11] B. Halamoda-Kenzaoui, S. Baconnier, T. Bastogne, D. Bazile, P. Boisseau, G. Borchard, S. E. Borgos, L. Calzolai, K. Cederbrant, G. di Felice, T. Di Francesco, M. Dobrovolskaia, R. Gaspar, B. Gracia, V. A. Hackley, L. Leyens, N. Liptrott, M. Park, A. Patri, G. Roebben, M. Roesslein, R. Thürmer, P. Urban Lopez, V. Zuang, and S. Bremer-Hoffmann, “Bridging communities in the field of nanomedicine,” Regulatory Toxicology and Pharmacology, 2019.
[12] L. Batista, T. Bastogne, A. Delaunois, J.-P. Valentin, and F. Atienzar, “A statistical signal processing method to rank drug effects in cardiomyocyte impedance assays.,” Biomedical Signal Processing and Control, vol. 45, pp. 202–212, 2018.
[13] G. Vogin, T. Bastogne, L. Bodgi, J. Gillet-Daubin, A. Canet, S. Pereira, and N. Foray, “The pATM Immunofluorescence assay: a high-performance radiosensitivity assay to predict post radiotherapy over-reactions.,” International Journal of Radiation Oncology - Biology - Physics, vol. 101, no. 3, pp. 1–8, 2018
[14] T. Bastogne, J.-L. Marchand, S. Pinel, and P. Vallois, “A branching process model of heterogeneous DNA damages caused by radiotherapy in in vitro cell cultures,” Mathematical Biosciences, vol. 294, pp. 100–109, 2017.
[15] P. Retif, T. Bastogne, and M. Barberi-Heyob, “Robustness analysis of a Geant4-Gate simulator for nano-radiosensitizers characterization,” IEEE Transactions on NanoBioscience, vol. 15, no. 3, pp. 209–217, 2016.
[16] P. Retif, A. Reinhard, P. Héna, V. Jouan-Hureaux, A. Chateau, L. Sancey, M. Barberi-Heyob, S. Pinel, and T. Bastogne, “Monte Carlo simulations guided by imaging to predict the in vitro ranking of radiosensitizing nanoparticles,” International Journal of Nanomedicine, 2016.
[17] J.-B. Tylcz, T. T. Bastogne, A. Bourguignon, C. Frochot, and M. Barberi-Heyob, “Realtime tracking of the Photobleaching Trajectory during Photodynamic Therapy,” IEEE Transactions on Biomedical Engineering, 2016.
[18] P. Retif, S. Pinel, M. Toussaint, C. Frochot, R. Chouikrat, T. Bastogne, and M. Barberi-Heyob, “Nanoparticles for radiation therapy enhancement: the key parameters,” Theranostics, vol. 5, no. 9, pp. 1030–1044, 2015.
[19] J.-B. Tylcz, K. El Alaoui-Lasmaili, E.-H. Djermoune, N. Thomas, B. Faivre, and T. Bastogne, “Data- driven modeling and characterization of anti-angiogenic molecule effects on tumoral vascular density,” Biomedical Signal Processing and Control, vol. 20, pp. 52–60, July 2015.
[20] J.-B. Tylcz, T. Bastogne, H. Benachour, D. Bechet, E. Bullinger, H. Garnier, and M. Barberi-Heyob, “A Model-based Pharmacokinetics Characterization Method of Engineered Nanoparticles for Pilot Studies,” IEEE Transactions on NanoBioscience, pp. Volume:PP , Issue: 99, Apr. 2015.
[21] S. Dobre, T. Bastogne, C. Profeta, M. Barberi-Heyob, and A. Richard, “Limits of variance-based sensi- tivity analysis for non- identifiability testing in high dimensional dynamic models,” Automatica, vol. 48, pp. 2740–2749, Aug. 2012.
[22] T. Bastogne, A. Samson, , P. Vallois, S. Wantz-Mézières, S. Pinel, D. Bechet, and M. Barberi-Heyob, “Phenomenological modeling of tumor diameter growth based on a mixed effects model,” Journal of Theoretical Biology, vol. 262, pp. 544–552, 2010.
[23] L. Tirand, T. Bastogne, D. Bechet, M. Linder, N. Thomas, C. Frochot, F. Guillemin, and M. Barberi-Heyob, “Response surface methodology: an extensive potential to optimize photodynamic therapy conditions in vivo,” International Journal of Radiation Oncology, Biology, Physics, vol. 75, no. 1, pp. 244–252, 2009.
[24] J. Gravier, R. Schneider, C. Frochot, T. Bastogne, F. Schmitt, J. Didelon, F. Guillemin, and M. Barberi-Heyob, “Improvement of m-THPC-like photosensitizer selectivity with folate-based targeted delivery. Synthesis and in vivo selective delivery study,” Journal of Medicinal Chemistry, vol. 51, pp. 3867–3877, June 2008.

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