Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER. [PDF]
Ther Innov Regul Sci, 2023 The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) have been leaders in protecting and promoting the U.S.
Ionan AC +8 more
europepmc +2 more sources
Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective. [PDF]
Pharmaceuticals (Basel)Artificial Intelligence (AI) has the disruptive potential to transform patients’ lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing.
Mirakhori F, Niazi SK.
europepmc +2 more sources
Comparability Considerations and Challenges for Expedited Development Programs for Biological Products. [PDF]
Drugs R D, 2020 Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed clinical development timeframes.
Schrieber SJ +8 more
europepmc +2 more sources
Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials". [PDF]
AAPS J, 2019 To guide developers of innovative and generic drug products that contain nanomaterials, the U.S. Food and Drug Administration issued the draft guidance for industry titled: “Drug Products, Including Biological Products, that Contain Nanomaterials” in ...
de Vlieger JSB +8 more
europepmc +2 more sources
Comparative Price Analysis of Biological Products for Treatment of Rheumatoid Arthritis. [PDF]
Front Pharmacol, 2018 Biological products for treatment of rheumatoid arthritis usually are cost effective for healthcare systems in Europe, but they are huge financial burden due to the high number of patients and the significant budget impact.
Manova M +7 more
europepmc +2 more sources
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary. [PDF]
Clin Pharmacol Ther, 2017 This report serves as a summary of a 2‐day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation.
Wang J +19 more
europepmc +2 more sources
Biological Activities of Natural Products [PDF]
Molecules, 2020 Natural products and their biological activities are currently a subject of great interest in the pharmaceutical, health food, and cosmetics industries, and numbers of scientific studies in this field are increasing rapidly [...]
Halina Maria Ekiert, Agnieszka Szopa
openaire +4 more sources
Partnership for productive development of biosimilar products: perspectives of access to biological products in the Brazilian market. [PDF]
Einstein (Sao Paulo), 2018 The manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the ...
Scheinberg MA +4 more
europepmc +2 more sources
Annals of the New York Academy of Sciences, 2017 The most advanced regulatory processes for complex biological products have been put in place in many countries to provide appropriate regulatory oversight of biotherapeutic products in general, and similar biotherapeutics in particular.
Ivana Knežević
exaly +2 more sources
Evaluating and Reporting the Immunogenicity Impacts for Biological Products--a Clinical Pharmacology Perspective. [PDF]
AAPS J, 2016 Wang YM +5 more
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