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Pharmaceutical Regulatory Science

International Journal of Pharmaceutical Research and Applications
TitlePharmaceutical Regulatory Science Authors / Editors Editor: Dr. Ravi Shankar Tripathi Co-Editor: Dr. Pravin Badhe Contributing Authors: Sushmita Hiremath; Nikhil Gawas; Bono Naga Sudha; Thokala Ujwala Reddy; Kanchanam AshaDeepthi; Shaik Shabana; Dr. Vivek R. Mallurwar; Reema Sanghvi; Dr.
Dr. Ravi Shankar Tripathi, Sushmita Hiremath, Nikhil Gawas, Bono Naga Sudha, Thokala Ujwala Reddy, Kanchanam AshaDeepthi, Shaik Shabana, Dr. Vivek R. Mallurwar, Reema Sanghvi, Dr. Sivakumar Kullampalayam Krishnasamy., Dr. Abinaya Mouralidasse, Yarra Sai Phanindra, Mrs. Kandregula Kesava Uma Maheswari   +1 more
semanticscholar   +3 more sources

Legitimizing Values in Regulatory Science [PDF]

Environmental Health Perspectives, 2019
Over the last several decades, scientists and social groups have frequently raised concerns about politicization or political interference in regulatory science. Public actors (environmentalists and industry advocates, politically aligned public figures, scientists and political commentators, in the United States as well as in other countries) across ...
Pinto, Manuela Fernández, Hicks, Daniel J   +1 more
openaire   +5 more sources

Bayesian Methods in Regulatory Science [PDF]

Statistics in Biopharmaceutical Research, 2019
Regulatory science comprises the tools, standards, and approaches that regulators use to assess safety, efficacy, quality, and performance of drugs and medical devices. A major focus of regulatory science is the design and analysis of clinical trials. Clinical trials are an essential part of clinical research programs that aim to improve therapies and ...
G. Rosner
openaire   +3 more sources

Sensitivity analysis for causality in observational studies for regulatory science. [PDF]

J Clin Transl Sci, 2023
Objective: The United States Congress passed the 21st Century Cures Act mandating the development of Food and Drug Administration guidance on regulatory use of real-world evidence.
Díaz I, Lee H, Kıcıman E, Schenck EJ, Akacha M, Follman D, Ghosh D.   +6 more
europepmc   +3 more sources

Is regulatory science ready for artificial intelligence? [PDF]

NPJ Digit Med
Trust is key in AI for regulatory science, but its definition is debated. If AI models use different features yet perform similarly, which should be trusted? If scientific theories must be testable, how critical is explainability? At the Global Summit on
Hartung T, Whelan M, Tong W, Califf RM.
europepmc   +2 more sources

Regulatory Science

Journal of Japan Society of Computer Aided Surgery, 2016
K. Chinzei
openaire   +5 more sources

New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science. [PDF]

Front Med (Lausanne), 2022
The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency.
Chiu K, Racz R, Burkhart K, Florian J, Ford K, Iveth Garcia M, Geiger RM, Howard KE, Hyland PL, Ismaiel OA, Kruhlak NL, Li Z, Matta MK, Prentice KW, Shah A, Stavitskaya L, Volpe DA, Weaver JL, Wu WW, Rouse R, Strauss DG.   +20 more
europepmc   +2 more sources

Advancing EFSA's regulatory science: Updated research and innovation needs. [PDF]

EFSA J
This editorial provides an update on research & innovation (R&I) needs that can support EFSA's regulatory science in the coming years. The paper presents research needs for EFSA's work in a number of domains: omics technologies; gut microbiome; new ...
European Food Safety Authority (EFSA), Bronzwaer S, Devos Y, Dorne JCM, Dujardin B, Dumont AF, Heppner C, Fernández EN, Paraskevopoulos K, das Neves CG.   +9 more
europepmc   +2 more sources

From traditional medicine to modern medicine: the importance of TCM regulatory science (TCMRS) as an emerging discipline. [PDF]

Chin Med
Traditional Chinese medicine (TCM) has become a standardized medical system through systematic development across global healthcare practices. However, concerns persist regarding the safety, efficacy and quality of traditional medicinal products ...
Hua H, Tang JY, Zhao JN, Wang T, Zhang JH, Yu JY, Yang CM, Ai YL, Luo QX.   +8 more
europepmc   +2 more sources

Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science. [PDF]

Bioact Mater
Nanomaterials and nanotechnology are emerging as promising strategies for medical devices due to their advantageous properties, including the ability to effectively interact with biomolecules and tissues, as well as enhance therapeutic efficacy and ...
Lin C, Huang X, Xue Y, Jiang S, Chen C, Liu Y, Chen K.   +6 more
europepmc   +2 more sources