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Margarida Miranda graduated in Pharmaceutical Sciences from the University of Lisbon, and has a PhD in Pharmaceutical Technology from University of Coimbra. Her doctoral thesis, held in partnership with Laboratórios Basi, a Portuguese Pharmaceutical company, focus on the regulatory constraints involved in establishing topical bioequivalence. After completing her PhD, she started working at Laboratórios Basi as a topical bioequivalence expert, with the goal to enhance patient access to affordable, high quality topical medicines. Her responsibilities include the strategic provision of technical support to semisolid product development partnering activities, especially those that focus on bioequivalence documentation. Furthermore, she teaches Pharmaceutical technology at Egas Moniz School of Health & Science, where she is an advocate of encouraging students to interact with industry as early, and as much as possible. Margarida has published, as first author, several scientific papers in peer reviewed high impact journals. She acts as a reviewer in several international scientific journals and has organized and moderated both international, as well as national congresses.
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Identification

Personal identification

Full name
Margarida Isabel Silva Coutinho de Miranda Rodrigues

Citation names

  • Miranda, Margarida

Author identifiers

Ciência ID
F513-02B4-5EDA
ORCID iD
0000-0002-4142-8455

Telephones

Mobile phone
  • 912875838 (Personal)

Knowledge fields

  • Medical and Health Sciences - Basic Medicine - Pharmacology and pharmacy

Languages

Language Speaking Reading Writing Listening Peer-review
English Advanced (C1) Advanced (C1) Advanced (C1) Advanced (C1) Advanced (C1)
Portuguese (Mother tongue)
Spanish; Castilian Intermediate (B1) Intermediate (B1) Intermediate (B1) Intermediate (B1) Elementary (A2)
Education
Degree Classification
2017/03/01 - 2022/04/07
Concluded
 Margarida Miranda (Doutoramento)
Universidade de Coimbra Faculdade de Farmácia, Portugal
"Topical bioequivalence: Experimental and regulatory considerations " (THESIS/DISSERTATION)
2017/01 - 2017/01
Attended
 SafeSciMET course 2.2 - Regulatory Requirements and Guidelines (Especialização pós-licenciatura)
Universität Konstanz, Germany

Universidade de Lisboa Faculdade de Farmácia, Portugal
2010/09/01 - 2015/10/01
Concluded
 Mestrado integrado em ciências farmacêuticas (Mestrado integrado)
Universidade de Lisboa Faculdade de Farmácia, Portugal
2014/04 - 2014/07
Concluded
 Curso de Formação Pedagógica Inicial de Formadores (Curso de Especialização Tecnológica)
Mindform, Formação Profissional e Consultadoria, Lda, Portugal
Affiliation

Science

Category
Host institution 		Employer
2017/03/01 - Current Researcher (Research) Universidade de Coimbra Centro de Química de Coimbra, Portugal
Universidade de Coimbra Centro de Química de Coimbra, Portugal

Teaching in Higher Education

Category
Host institution 		Employer
2022/09/01 - Current Assistant Professor (University Teacher) Egas Moniz Cooperativa de Ensino Superior CRL, Portugal

Other Careers

Category
Host institution 		Employer
2021/12 - 2023/10/25 Técnico Superior (Técnico Superior) Laboratórios Basi - Indústria Farmacêutica SA, Portugal
2015/10 - 2016/12 Técnico Superior (Técnico Superior) Farmácia Alvide, Portugal
Projects

Grant

Designation Funders
2017/03/01 - 2021/12/31 Topical Bioequivalence: Experimental and Regulatory Considerations
PD/BDE/135075/2017
PhD Student Fellow
Universidade de Coimbra Faculdade de Farmácia, Portugal

Laboratórios Basi - Indústria Farmacêutica SA, Portugal
Ongoing
Outputs

Publications

Book
  1. Célia Cabral; Miranda, Margarida; João Rui Pita. Peças com história da Faculdade de Farmácia da Universidade de Coimbr. Coimbra, Portugal: Faculdade de Farmácia da Universidade de Coimbra. 2017.
    Published
  2. Cabral, Célia; Miranda, Margarida; Pita, João Rui. Peças com história da Faculdade de Farmácia da Universidade de Coimbra. Coimbra, Portugal: Faculdade de Farmácia da Universidade de Coimbra. 2017.
    Published
Book chapter
  1. Miranda, Margarida; Alberto A. C. C. Pais; Carla Sofia Pinheiro Vitorino. Corresponding author: Carla Sofia Pinheiro Vitorino. "Topical Bioequivalence Design Studies: An Update". In Time-Proof Perspectives on Bioequivalence. 2023.
    Published
  2. Mariana Neves; Miranda, Margarida; Fortuna, Ana; João José Sousa; Carla Sofia Pinheiro Vitorino. "Physiologically-Based Pharmacokinetic Modeling to Support the Determination of Drug Product Bioequivalence". In Time-Proof Perspectives on Bioequivalence. 2023.
    Published
  3. Miranda, Margarida. "A regulatory framework for the development of topical nanomedicines". In Theory and Applications of Nonparenteral Nanomedicines, 55-78. 2021.
    Published
  4. Miranda, M.; Cardoso, C.; Vitorino, C.. "A regulatory framework for the development of topical nanomedicines". 55-78. 2020.
Conference poster
  1. Patricia Henriques; João Marques; Miranda, Margarida; Ana Fortuna; Slavomíra Doktorovová. "Amorphous Solid Dispersions for Nasal Delivery: a step towards formulating poorly-soluble drugs for nasal administration". Paper presented in 2th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, 2021.
  2. Patricia Henriques; João Marques; Miranda, Margarida; Ana Fortuna; Maria Braga; Slavomíra Doktorovová. "Amorphous Solid Dispersions for Nasal Delivery: Development, Characterization and Performance Stud". Paper presented in RDD21, 2021.
  3. Miranda, Margarida; Cova, Tânia Firmino Guerra Guerreiro da; Pais, Alberto A. C. C.; Catarina Joana Dias Neto Pratas Cardoso; Carla Sofia Pinheiro Vitorino. Corresponding author: Carla Sofia Pinheiro Vitorino. "Batch-to-batch variability of semisolid topical drug products". Paper presented in 1st Annual Meeting in Pharmaceutical Sciences, 2019.
  4. Miranda, Margarida; Cova, Tânia Firmino Guerra Guerreiro da; Augusto, Cátia; Pais, Alberto A. C. C.; Catarina Joana Dias Neto Pratas Cardoso; Carla Sofia Pinheiro Vitorino. Corresponding author: Carla Sofia Pinheiro Vitorino. "Batch-to-batch variability of semisolid topical drug products". Paper presented in Okinawa Colloids 2019, 2019.
  5. Miranda, Margarida; Pais, Alberto A. C. C.; Catarina Joana Dias Neto Pratas Cardoso; Carla Sofia Pinheiro Vitorino. Corresponding author: Carla Sofia Pinheiro Vitorino. "aQbD as a Framework for in vitro Release Testing Development". Paper presented in Skin & Formulation 5th Symposium & 17th Skin Forum, 2019.
  6. Miranda, Margarida; Catarina Joana Dias Neto Pratas Cardoso; Carla Sofia Pinheiro Vitorino. Corresponding author: Carla Sofia Pinheiro Vitorino. "Bioequivalence of topical generic products: Where are we now?". Paper presented in Skin Forum 2018 Annual Metting, 2018.
  7. Miranda, Margarida; Minas da Piedade, M. E.; Bernardes, C. E. S.; Figueirinha, Artur; Carla Sofia Pinheiro Vitorino; Célia Cabral. "Development of a NLC hydrogel loaded with Ridolfia segetum (L.) Moris essential oil". Paper presented in 21st International Symposium on Microencapsulation, 2017.
  8. Célia Cabral; Miranda, Margarida; M. J. Gonçalves; Cavaleiro, Carlos; Cruz, Maria Teresa; Ligia Salgueiro. "Essential oil of the Portuguese endemic Santolina impressa Hoffmanns. & Link: assessment of antifungal safe doses". Paper presented in 6th International Congress of Aromatic and Medicinal Plants (CIPAM2016), 2016.
  9. Célia Cabral; Miranda, Margarida; M. J. Gonçalves; Cruz, Maria Teresa; Cavaleiro, Carlos; Salgueiro, Lígia. "Assessment of safe bioactive doses of Foeniculum vulgare Mill. essential oil from Portugal". Paper presented in 6th International Congress of Aromatic and Medicinal Plants (CIPAM2016), 2016.
  10. Célia Cabral; Miranda, Margarida; Carolina Rodrigues; João Ferreira; Salgueiro, Lígia. "The medicinal plants in the Historical-Pharmaceutical Heritage of the Faculty of Pharmacy of the University of Coimbra (Portugal)". Paper presented in 6th International Congress of Aromatic and Medicinal Plants (CIPAM2016), 2016.
Edited book
  1. Marta Simões; Maria de Fátima Pina; Daniela Zagalo; Ana M Martins; Marc Brown; Miranda, Margarida; Dina Ameen; et al. Time-Proof Perspectives on Bioequivalence. New York, United States: Nova Science Publishers. 2023.
    Published • 10.52305/wknm2164
Journal article
  1. Diogo Lourenço; Margarida Miranda; João Jose Sousa; Carla Vitorino. "Therapeutic-driven framework for bioequivalence assessment of complex topical generic drug products". International Journal of Pharmaceutics (2024): http://dx.doi.org/10.1016/j.ijpharm.2024.124398.
    10.1016/j.ijpharm.2024.124398
  2. Brown, Marc; Williams, Adrian; Chilcott, Robert P.; Brady, Brendan; Lenn, Jon; Evans, Charles; Allen, Lynn; et al. "Topically Applied therapies for the treatment of skin disease : Past Present and Future". Pharmacological Reviews (2024): PHARMREV-AR. http://dx.doi.org/10.1124/pharmrev.123.000549.
    10.1124/pharmrev.123.000549
  3. Miranda, Margarida; Volmer, Zoe; Cornick, Alicia; Goody, Aidan; Cardoso, Catarina; Pais, Alberto A.C.C.; Brown, Marc; Vitorino, Carla. "In vitro studies into establishing therapeutic bioequivalence of complex topical products: Weight of evidence". International Journal of Pharmaceutics 656 (2024): 124012. http://dx.doi.org/10.1016/j.ijpharm.2024.124012.
    10.1016/j.ijpharm.2024.124012
  4. Lucas Chiarentin; Carla Gonçalves; Cátia Augusto; Margarida Miranda; Catarina Cardoso; Carla Vitorino. "Drilling into “Quality by Design” Approach for Analytical Methods". Critical Reviews in Analytical Chemistry (2023): http://dx.doi.org/10.1080/10408347.2023.2253321.
    10.1080/10408347.2023.2253321
  5. Patrícia Henriques; Joana Bicker; Andreia Carona; Margarida Miranda; Carla Vitorino; Slavomíra Doktorovová; Ana Fortuna. "Amorphous nasal powder advanced performance: in vitro/ex vivo studies and correlation with in vivo pharmacokinetics". Journal of Pharmaceutical Investigation (2023): http://dx.doi.org/10.1007/s40005-023-00630-1.
    10.1007/s40005-023-00630-1
  6. Chiarentin, Lucas; Cardoso, Catarina; Miranda, Margarida; Vitorino, Carla. "Rheology of Complex Topical Formulations: An Analytical Quality by Design Approach to Method Optimization and Validation". Pharmaceutics 15 7 (2023): 1810. http://dx.doi.org/10.3390/pharmaceutics15071810.
    10.3390/pharmaceutics15071810
  7. Miranda, Margarida; Cardoso, Catarina; Pais, Alberto A.C.C.; Brown, Marc; Vitorino, Carla. "Drilling down the bioequivalence assessment of topical antifungal products: Microstructure and release". European Journal of Pharmaceutics and Biopharmaceutics 185 (2023): 94-106. http://dx.doi.org/10.1016/j.ejpb.2023.02.006.
    10.1016/j.ejpb.2023.02.006
  8. Brites, Gonçalo; Basso, João; Miranda, Margarida; Miguel Neves, Bruno; Vitorino, Carla; Cruz, Maria T.. "Development of a new hydrogel for the prevention of allergic contact dermatitis". International Journal of Pharmaceutics 628 (2022): 122265. http://dx.doi.org/10.1016/j.ijpharm.2022.122265.
    10.1016/j.ijpharm.2022.122265
  9. Miranda, Margarida; Veloso, Cláudia; Brown, Marc; C. Pais, Alberto A.C.; Cardoso, Catarina; Vitorino, Carla. "Topical bioequivalence: Experimental and regulatory considerations following formulation complexity". International Journal of Pharmaceutics 620 (2022): 121705. http://dx.doi.org/10.1016/j.ijpharm.2022.121705.
    10.1016/j.ijpharm.2022.121705
  10. Margarida Miranda; Cláudia Veloso; Catarina Cardoso; Carla Vitorino. "From Lab to Upscale - Boosting Formulation Performance through In Vitro Technologies". Proceedings (2020): https://doi.org/10.3390/IECP2020-08674.
    10.3390/IECP2020-08674
  11. Miranda, Margarida; Cova, Tânia; Augusto, Cátia; Pais, Alberto A. C. C.; Cardoso, Catarina; Vitorino, Carla. "Diving into Batch-to-Batch Variability of Topical Products-a Regulatory Bottleneck". Pharmaceutical Research 37 11 (2020): http://dx.doi.org/10.1007/s11095-020-02911-y.
    10.1007/s11095-020-02911-y
  12. Miranda, Margarida. "Rheology by Design: A Regulatory Tutorial for Analytical Method Validation". Pharmaceutics (2020): http://dx.doi.org/10.3390/pharmaceutics12090820.
    10.3390/pharmaceutics12090820
  13. Miranda, Margarida. "Quality and equivalence of topical products: A critical appraisal". European Journal of Pharmaceutical Sciences (2020): http://dx.doi.org/10.1016/j.ejps.2019.105082.
    10.1016/j.ejps.2019.105082
  14. Miranda, Margarida. "Fast Screening Methods for the Analysis of Topical Drug Products". Processes (2020): http://dx.doi.org/10.3390/pr8040397.
    10.3390/pr8040397
  15. Miranda, Margarida. "aQbD as a platform for IVRT method development – A regulatory oriented approach". International Journal of Pharmaceutics (2019): http://dx.doi.org/10.1016/j.ijpharm.2019.118695.
    10.1016/j.ijpharm.2019.118695
  16. Miranda, Margarida. "Nanostructuring lipid carriers using Ridolfia segetum (L.) Moris essential oil". Materials Science and Engineering: C (2019): http://dx.doi.org/10.1016/j.msec.2019.109804.
    10.1016/j.msec.2019.109804
  17. Miranda, Margarida. "Bioequivalence of topical generic products. Part 1: Where are we now?". European Journal of Pharmaceutical Sciences (2018): http://dx.doi.org/10.1016/j.ejps.2018.07.050.
    10.1016/j.ejps.2018.07.050
  18. Miranda, Margarida. "Bioequivalence of topical generic products. Part 2. Paving the way to a tailored regulatory system". European Journal of Pharmaceutical Sciences (2018): http://dx.doi.org/10.1016/j.ejps.2018.07.011.
    10.1016/j.ejps.2018.07.011
  19. Miranda, Margarida. "Understanding the Inguinal Sinus in Sheep (Ovis aries) - Morphology, Secretion, and Expression of Progesterone, Estrogens, and Prolactin Receptors". International Journal of Molecular Sciences (2017): http://www.mdpi.com/1422-0067/18/7/1516.
    10.3390/ijms18071516
  20. Cabral, C.; Miranda, M.; Gonçalves, M. J.; Cavaleiro, C.; Cruz, M. T.; Salgueiro, L.. Corresponding author: Cabral, C.. "Assessment of safe bioactive doses of Foeniculum vulgare Mill. essential oil from Portugal". Natural Product Research 31 22 (2017): 2654-2659. http://dx.doi.org/10.1080/14786419.2017.1292266.
    10.1080/14786419.2017.1292266
Activities

Oral presentation

Presentation title Event name
Host (Event location)
2023/10 Tackling formulation complexity in the development and optimization of a rheology method for complex semisolid formulation: an analytical quality by design (aQbD) approach Skin & Formulation – 6th Symposium
(Nantes, France)
2023/06/02 Tackling formulation complexity in bioequivalence assessment of topical generic products EUFEPS Annual Meeting 2023
EUFEPS (Lisbon, Portugal)
2019/11/15 aQbD as a Framework for in vitro Release Testing Development 1st Annual Meeting in Pharmaceutical Sciences
Faculty of Pharmacy University of Coimbra (Coimbra, Portugal)
2019/07/22 aQbD as a Framework for in vitro Release Testing Development Control Release Society 46th Annual Meeting
Control Release Society (Valencia, Spain)
2019/06/19 aQbD as a Framework for in vitro Release Testing Development Brain delivery workshop
Faculty of Pharmacy University of Coimbra (Coimbra, Portugal)

Event organisation

Event name
Type of event (Role) 		Institution / Organization
2019/11/15 - 2019/11/15 Organizing committee of the 1st Annual Meeting in Pharmaceutical Sciences (2019/11/15 - 2019/11/15)
Congress (Member of the Organising Committee)
 Universidade de Coimbra Faculdade de Farmácia, Portugal
2018/09/27 - 2018/09/28 Co-chair of the 1st Drugs R&D Ph.D. Symposium - Translational Science: From Academia to Industry (2018/09/27 - 2018/09/28)
Conference (Co-organisor)
 Universidade de Coimbra Faculdade de Farmácia, Portugal
2016/05/29 - 2016/06/01 Organizer of the 6th International Congress of Aromatic and Medicinal Plants (CIPAM 2016) (2016/05/29 - 2016/06/01)
Congress (Other)
 Universidade de Coimbra Faculdade de Farmácia, Portugal