Article
Pharmacology & Pharmacy
Elisabeth Bakker, Kelly Plueschke, Carla J. Jonker, Xavier Kurz, Viktoriia Starokozhko, Peter G. M. Mol
Summary: Real-world data/evidence (RWD/RWE) can provide insightful information on medicines' clinical effects and guide regulatory decisions. However, further evaluation is needed to use RWD/RWE to demonstrate the efficacy of medicines. This study characterized RWD/RWE presented by applicants and analyzed its contribution to regulatory decisions on the benefit-risk profile of medicines. Common limitations of submitted RWD/RWE included missing data, lack of representativeness, and bias risks.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Pharmacology & Pharmacy
Noa Rosenberg, Sibren van den Berg, Nina N. Stolwijk, Bart A. W. Jacobs, Hendrika C. Post, Anna M. G. Pasmooij, Saco J. de Visser, Carla E. M. Hollak
Summary: This paper provides an easily applicable roadmap for academic researchers to make rare disease medicines available for patients. It emphasizes the importance of interaction with regulators and highlights alternative routes for timely access to medicines. Aligning academic studies with regulatory and reimbursement requirements is crucial for improving access to rare disease medicines.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Medicine, General & Internal
Valentina Vignali, Philip A. Hines, Ana Gloria Cruz, Barbara Zietek, Ralf Herold
Summary: In the field of medicine development, it is crucial to keep up with the rapid progress in science and technology to translate them into benefits for society. Using horizon scanning, the European Medicines Agency collaborates with WHO and DG JRC to identify early signals of relevant innovation and technological trends in medicinal products. This helps inform policy-makers of new trends and improve preparedness in responding to them.
FRONTIERS IN MEDICINE
(2022)
Article
Dermatology
Andreas Wollenberg, Jacob P. Thyssen, Thomas Bieber, Gary Chan, Urs Kerkmann
Summary: The PRAC of the EMA has reevaluated the benefit-risk balance of oral JAKi and recommended their use only if no suitable alternatives are available. They should be used with caution in patients with certain risk factors, and the European Commission has made a final decision in March 2023.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2023)
Article
International Relations
Matthew Wood
Summary: This article analyzes the European Medicines Agency's first attempt at democratic innovation within transnational European Union institutions in 2017. Despite some shortcomings, the public hearing demonstrated deliberative qualities that provided more equal access and influence for the public.
BRITISH JOURNAL OF POLITICS & INTERNATIONAL RELATIONS
(2022)
Article
Political Science
Dovile Rimkute, Honorata Mazepus
Summary: Agencification in the EU extends the authority of European regulatory state to new policy domains traditionally handled by national institutions. This study examines the legitimacy of EU agencies, particularly the European Medicines Agency (EMA) in authorizing vaccines for cross-border health security risks. The findings suggest that the EMA is perceived as highly legitimate, and disapproval from national-level politicians and citizens does not undermine its epistemic authority in the eyes of local decision-makers.
JOURNAL OF EUROPEAN PUBLIC POLICY
(2023)
Article
Medicine, General & Internal
Natalie M. Hendrikse, Jordi Llinares Garcia, Thorsten Vetter, Anthony J. Humphreys, Falk Ehmann
Summary: Biomarkers play a crucial role in drug development and clinical practice, with the European Medicines Agency emphasizing the importance of their discovery and use. Early engagement with regulators is crucial for biomarker qualification, and there are opportunities to improve support for developers by EMA. Qualified biomarkers are important for enabling precision medicine in clinical trials.
FRONTIERS IN MEDICINE
(2022)
Article
Health Care Sciences & Services
Asger Sand Paludan-Muller, Ingrid Rose Maclean-Nyegaard, Klaus Munkholm
Summary: Reporting bias poses a threat to the transparency and validity of clinical trials, and accessing Clinical Study Reports (CSRs) can mitigate this to some extent. The European Medicines Agency (EMA) publishes clinical data under their Policy 0070, but there are considerable delays in the publications, reducing their potential impact on reporting bias.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2022)
Article
Behavioral Sciences
Alexander Chouker, Thu Jennifer Ngo-Anh, Robin Biesbroek, Gerhard Heldmaier, Marc Heppener, Juergen Bereiter-Hahn
Summary: Long-duration space missions to Mars will create extreme physical and psychological stress on the crew, as well as logistical and technical challenges. ESA's study has shown that biological hibernation can reduce crew metabolism and stress, but will require monitoring and AI assistance.
NEUROSCIENCE AND BIOBEHAVIORAL REVIEWS
(2021)
Article
Medicine, General & Internal
Robbe Saesen, Matilde Machado, Bianca Crifo, Lifang Liu, Corinne de Vries, Ralf Herold, Jordi Llinares Garcia, Isabelle Huys
Summary: The European Medicines Agency (EMA) has collaborated with academic researchers in recent years, participating in external research projects. This study evaluates the perceived value of EMA's involvement in these projects from the perspectives of both EMA staff and project coordinators.
FRONTIERS IN MEDICINE
(2023)
Article
Business
Shunsuke Managi, Robert Lindner, Casey C. Stevens
Summary: Technology policy is essential in achieving the Sustainable Development Goals, requiring more global cooperation and resource sharing, while also addressing the challenges posed by uneven global distribution of innovation and development capacities.
TECHNOLOGICAL FORECASTING AND SOCIAL CHANGE
(2021)
Review
Pharmacology & Pharmacy
Kevin Klein, Pieter Stolk, Marie Louise De Bruin, Hubert Leufkens
Summary: With continuous advancements in science, society, and technology, drug development is becoming more complex, posing unprecedented challenges for global regulatory systems. To address these challenges, a more tailored and flexible regulatory approach is needed, prompting a reconsideration of regulatory methods for future complex medicines.
DRUG DISCOVERY TODAY
(2021)
Article
Green & Sustainable Science & Technology
Nicola Moczek, Silke L. Voigt-Heucke, Kim G. Mortega, Claudia Fabo Cartas, Joern Knobloch
Summary: European citizen science projects contribute most to 'Good health and well-being', 'Quality education', and 'Life on Land' SDGs. The survey indicates a lack of infrastructures and institutional support for data sharing in these projects. Recommendations include promoting interfaces between projects and UN databases.
Article
Public, Environmental & Occupational Health
Katrin Kurvits, Maia Uuskula, Helve Vestman, Ott Laius
Summary: This study aimed to investigate the changes in prescribing of fluoroquinolones after the recommendation by EMA in October 2018. The results showed a decline in the number of prescriptions, but a significant proportion of users still had risk factors for tendon injury and serious cardiac disorders.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
(2023)
Review
Integrative & Complementary Medicine
Zuanji Liang, Yunfeng Lai, Meng Li, Junnan Shi, Chi Ieong Lei, Hao Hu, Carolina Oi Lam Ung
Summary: The research has identified ten priority areas for the development of regulatory science for traditional Chinese medicines in China, including modernizing the regulatory system, advancing quality control methodology, improving manufacturing process control, enhancing clinical evaluation, developing evaluation standards for classic formula, harnessing diverse data for pharmacovigilance, evaluating the value of integrative medicine, encouraging innovation, and promoting collaboration for RS development.
Article
Pharmacology & Pharmacy
Philip A. Hines, Richard H. Guy, Angela Brand, Anthony J. Humphreys, Marisa Papaluca-Amati
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2020)
Article
Pharmacology & Pharmacy
M. Hoppel, M. A. M. Tabosa, A. L. Bunge, M. B. Delgado-Charro, R. H. Guy
Summary: This study successfully tested the input rates of nicotine and lidocaine into healthy human skin using tape-stripping method, revealing differences in drug delivery between transdermal patches and creams. The experimental approach was validated and confirmed using in vitro diffusion cells with pig skin samples.
Article
Medicine, Research & Experimental
Andrea Pensado, Laura Hattam, K. A. Jane White, Anita McGrogan, Annette L. Bunge, Richard H. Guy, M. Begona Delgado-Charro
Summary: Prediction of skin absorption and local bioavailability from topical formulations remains a challenging task, with current research focusing on developing a physiologically based pharmacokinetic model to predict distribution and absorption of complex dermatological products. In vitro experimental results were consistent with commercial product performance and new skin sampling data demonstrated the input rate and drug delivery requirements of the Scopoderm patch.
MOLECULAR PHARMACEUTICS
(2021)
Article
Pharmacology & Pharmacy
M. Alice Maciel Tabosa, Sarah F. Cordery, K. A. Jane White, Annette L. Bunge, Richard H. Guy, M. Begona Delgado-Charro
Summary: The role of excipients in the partitioning and diffusion of drugs in the skin is crucial in the development of dermatological drug products. This study correlated the skin pharmacokinetics of diclofenac and the co-uptake of two key excipients, propylene glycol and butylene glycol, in human subjects. The results highlight the importance of considering the disposition of excipients in the optimization of drug delivery from topical formulations.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Instruments & Instrumentation
Andrea Pensado, Anita McGrogan, K. A. Jane White, Annette L. Bunge, Richard H. Guy, M. Begona Delgado-Charro
Summary: Predicting the dermal bioavailability of topically delivered drugs is challenging. The study found that the uptake of betamethasone valerate into the stratum corneum was significantly higher at a dose of 5 mg/cm² compared to doses of 2 and 10 mg/cm². Skin blanching responses varied widely and were not sensitive to the dose of cream applied. The tape-stripping method was able to detect differences between applied doses, providing quantitative metrics for corticosteroid delivery.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2022)
Article
Pharmacology & Pharmacy
Maxim Morin, Sebastian Bjorklund, Skaidre Jankovskaja, Kieran Moore, Maria Begona Delgado-Charro, Tautgirdas Ruzgas, Richard H. Guy, Johan Engblom
Summary: Non-invasive methods for early diagnosis of skin cancer are important. This study examined the use of reverse iontophoresis (RI) to enhance the extraction of tryptophan (Trp) and kynurenine (Kyn) for non-invasive sampling. The results showed that the Trp/Kyn ratio obtained from the skin surface matched that in the epidermal tissue. Increasing the pH of the receiver solution improved extraction efficiency, and using a bicontinuous cubic liquid crystal as the receiver medium showed comparable results to simple buffer solutions. Further in vivo investigations are warranted.
Correction
Medicine, Research & Experimental
Andrea Pensado, Laura Hattam, K. A. Jane White, Anita McGrogan, Annette L. Bunge, Richard H. Guy, M. Begon Delgado-Charro
MOLECULAR PHARMACEUTICS
(2022)
Article
Medicine, Research & Experimental
Hazel Garvie-Cook, Magdalena Hoppel, Richard H. Guy
Summary: This article illustrates the application of confocal Raman microspectroscopy and imaging to investigate the performance of topical and transdermal drug products at the formulation-skin interface. These techniques provide qualitative and potentially semi-quantitative insights into the interaction between the delivery system and the skin, drug transfer mechanisms, changes in drug solubility, and drug absorption and clearance within the skin.
MOLECULAR PHARMACEUTICS
(2022)
Article
Dermatology
O. Yelamos, D. Andersen, M. Pont, P. Iglesias, M. Potrony, M. Dominguez, A. Herrero, B. Alejo, J. Mateu, M. Ropke, N. B. Danneskiold-Samsoe, J. Malvehy, R. H. Guy, S. Brix, S. Puig
Summary: We developed a minimally invasive and image-guided tape stripping method for sampling atopic skin in children. This method is safe, reliable, and provides reproducible acquisition of cDNA. By comparing and optimizing skin tape stripping procedures using multiple imaging techniques, we successfully established a protocol that produced good cDNA yield without significant adverse events in a shorter time compared to previous methods. This minimally invasive method enables rapid sample collection, which is crucial in clinical practice.
CLINICAL AND EXPERIMENTAL DERMATOLOGY
(2023)
Article
Medicine, Research & Experimental
M. Alice Maciel Tabosa, Pauline Vitry, Panagiota Zarmpi, Annette L. Bunge, Natalie A. Belsey, Dimitrios Tsikritsis, Timothy J. Woodman, K. A. Jane White, M. Begona Delgado-Charro, Richard H. Guy
Summary: The evaluation of drug bioavailability in the skin requires quantitative and non-invasive experimental tools. In this study, infrared and Raman spectroscopies were used to assess the uptake of a chemical into the stratum corneum. Experiments on excised porcine skin showed good correlations between spectroscopic results and chemical quantification using the tape-stripping method. The spectroscopic approach can potentially be used to investigate chemical disposition deeper in the skin.
MOLECULAR PHARMACEUTICS
(2023)
Article
Biochemical Research Methods
Joan Eilstein, Vimal Nair, Kieran Moore, Steve Thomas Pannakal, Sebastien Gregoire, Prashant Ekhar, Richard H. Guy, M. Begona Delgado-Charro, Nita Roy
Summary: To commercially isolate phytochemicals, it is necessary to identify a suitable plant biomass source and conduct frequent analytical verification. Reverse iontophoretic (RI) sampling offers a potential solution that allows for non-destructive extraction of phytochemicals from different biomasses.
PHYTOCHEMICAL ANALYSIS
(2023)
Article
Medicine, Research & Experimental
Panagiota Zarmpi, M. Alice Maciel Tabosa, Pauline Vitry, Annette L. Bunge, Natalie A. Belsey, Dimitrios Tsikritsis, Timothy J. Woodman, M. Begona Delgado-Charro, Richard H. Guy
Summary: Confocal Raman spectroscopy is a promising tool for quantifying drug uptake and clearance in the skin, providing valuable insights into local bioavailability. This research confirmed that Raman signals can be used to correct for signal attenuation and detect drug disposition, as well as distinguish between different formulations.
MOLECULAR PHARMACEUTICS
(2023)
Article
Chemistry, Multidisciplinary
Kieran Moore, Shaun B. B. Reeksting, Vimal Nair, Steve T. T. Pannakal, Nita Roy, Joan Eilstein, Sebastien Gregoire, M. Begona Delgado-Charro, Richard H. H. Guy
Summary: Reverse iontophoresis (RI) was employed to non-destructively extract phytochemicals from intact fruits, and the extraction of ellagic acid from pomegranate fruit was successfully demonstrated. The RI sampling protocol was optimized, and multiple additional phytochemicals were also identified by LC-MS/MS.
Correction
Medicine, Research & Experimental
Andrea Pensado, Laura Hattam, K. A. . Jane White, Anita McGrogan, Annette L. Bunge, Richard H. Guy, M. Begona Delgado-Charro
MOLECULAR PHARMACEUTICS
(2022)
Article
Instruments & Instrumentation
Maria Alice Maciel Tabosa, Magdalena Hoppel, Annette L. Bunge, Richard H. Guy, M. Begona Delgado-Charro
Summary: The study shows that drug clearance from the difficult-to-access compartment in the skin can be inferred from systemic pharmacokinetic data, and is closely related to key physical chemical properties of the drug. A multiple regression analysis was used to determine this relationship and demonstrated that the model predictions correlated well with in vitro skin experiments.
DRUG DELIVERY AND TRANSLATIONAL RESEARCH
(2021)
