Papers matching “regulatory considerations” 167
Not finding it? Sign in to also search OpenAlex live.
-
Solution Oligonucleotide APIs: Regulatory Considerations2022 Therapeutic Innovation & Regulatory Science article Immunology and Microbiology Biosimilars and Bioanalytical Methods Open access
Christian Wetter, Chris Chorley, Corrine Curtis, Nicole del Canto, J. Gair Ford, Jennifer L. Franklin, +6 more
10citations -
Real‐World Evidence to Inform Regulatory Decision Making: A Scoping Review2024 Clinical Pharmacology & Therapeutics article Economics, Econometrics and Finance Pharmaceutical Economics and Policy Open access
Marieke S. Jansen, Olaf M. Dekkers, Saskia le Cessie, Lotty Hooft, Helga Gardarsdóttir, Anthonius de Boer, +1 more
10citations -
Considerations in the Preclinical Assessment of the Safety of Antisense Oligonucleotides2022 Nucleic Acid Therapeutics article Biochemistry, Genetics and Molecular Biology RNA Interference and Gene Delivery Open access cited by 3 patents
Aurélie Goyenvalle, Cecilia Jimenez-Mallebrera, Willeke van Roon‐Mom, Sabine Sewing, Arthur Μ. Krieg, Virginia Arechavala‐Gomeza, +1 more
94citations -
Adversity Considerations for Thyroid Follicular Cell Hypertrophy and Hyperplasia in Nonclinical Toxicity Studies: Results From the 6th ESTP International Expert Workshop2020 Toxicologic Pathology article Immunology and Microbiology Immunotoxicology and immune responses
Maike Huisinga, Lise Bertrand, Ronnie Chamanza, Isabelle Damiani, Jeffery A. Engelhardt, Sabine Francke, +16 more
34citations -
Development of tailored splice-switching oligonucleotides for progressive brain disorders in Europe: development, regulation, and implementation considerations
Annemieke M Aartsma-Rus, Willeke van Roon‐Mom, Marlen C. Lauffer, Christine L. E. Siezen, Britt Duijndam, Tineke Coenen-de Roo, +3 more
33citations -
Artificial Intelligence for Regulatory Evidence: A Systematic Document Analysis of European Medicines Agency Regulatory Advice and Public Reports2026 Clinical Pharmacology & Therapeutics article Medicine Artificial Intelligence in Healthcare and Education Open access
Lucina-May Nollen, Gerard J. P. van Westen, Gabriel Westman, Anna M.G. Pasmooij
1citations -
General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children2022 British Journal of Clinical Pharmacology article Medicine Pharmaceutical studies and practices Open access
Naïm Bouazza, Aristides Dokoumetzidis, Catherijne A. J. Knibbe, Saskia N. de Wildt, Claire L. Ambery, Pieter A. J. G. De Cock, +9 more
10citations -
Designing integrated early-phase protocols to reduce substantial modifications, including considerations for patient cohorts – a multi-stakeholder consensus view for a practical approach in Germany2026 Frontiers in Pharmacology article Mathematics Statistical Methods in Clinical Trials Open access
Robert Schultz-Heienbrok, S. Baumann, Ruwen Böhm, Andreas Bonertz, K. Breithaupt-Groegler, U. Buckpesch-Heberer, +12 more
0citations -
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions2025 Drug Safety article Pharmacology, Toxicology and Pharmaceutics Pharmacovigilance and Adverse Drug Reactions Open access
Jami Peters, Ayad K. Ali, Maria Moitinho de Almeida, Keiko Asao, Tarek A. Hammad, Xintong He, +5 more
0citations -
Advancing regulatory dialogue: In silico models for improved vaccine biomanufacturing - an expert meeting report2025 Vaccine article Biochemistry, Genetics and Molecular Biology Viral Infectious Diseases and Gene Expression in Insects Open access
Irina Meln, Wim Van Molle, Mónica Vélez, Greger Abrahamsen, Koen Brusselmans, Éric Calvosa, +19 more
6citations -
Regulatory and standardization framework analysis / D1.22026 Zenodo (CERN European Organization for Nuclear Research) article Engineering Smart Grid Security and Resilience Open access
L.R. Valencia Pérez, Alberto Dognini, Mário Couto, Efthimia Chassioti, Konstantinos F. Krommydas, Georgios A. Barzegkar‐Ntovom, +2 more
0citations -
Regulatory and standardization framework analysis / D1.22026 Zenodo (CERN European Organization for Nuclear Research) article Engineering Power Systems and Technologies Open access
L.R. Valencia Pérez, Alberto Dognini, Mário Couto, Efthimia Chassioti, Konstantinos F. Krommydas, Georgios A. Barzegkar‐Ntovom, +2 more
0citations -
Review of dose setting for the extended one-generation reproductive toxicity studies (OECD TG 443): Considerations on ECHA's dose level selection recommendations2024 Regulatory Toxicology and Pharmacology article Veterinary Animal testing and alternatives Open access
Manon E. W. Beekhuijzen, Jason C. Manton, Pragati Sawhney Coder, Katy O. Goyak, Rashin Ghaffari, Susan L. Makris, +3 more
9citations