FDA

Males and females respond differently to medications due to physiologic, metabolic, and genetic factors. At times, sex-related differences cannot be mitigated by dose adjustment to body mass, and are evident from the tissue level to the single cell. The rising number of clinically approved…
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WILMINGTON, Del., Oct. 31, 2022 -- Ashland Inc. (NYSE: ASH) today announced the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research Office of New Drugs has accepted Ashland Viatel™ bioresorbable mPEG-PDLLA pharmaceutical excipient in the review cycle of the FDA…
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CDER scientists are seeking ways to improve the bioavailability of drugs that on their own do not dissolve well in water. Recent CDER research explores the potential for using amorphous solid dispersions to formulate generic drug products that may include ingredients that are poorly water-soluble.…
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In this paper, we have studied Wurster Coating operation for the manufacture of modified release (MR) capsule products submitted to FDA as New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) by using a data-driven approach. We have collected and classified information into…
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Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility.…
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With the on-going pandemic, vaccine developing methods have gained attention of the scientific community, specially towards the production, downstream and transport aspects, making it clear that new methods with less complex production and transport are needed, especially for developing…
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Purpose Mixing with liquids or soft foods is a common procedure to improve acceptability of oral medicines in children but may affect drug stability and the in vivo performance of the administered drug product. The aim of the present study was to obtain an overview of the variability of critical…
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Liposomes have been considered promising and versatile drug vesicles. Compared with traditional drug delivery systems, liposomes exhibit better properties, including site-targeting, sustained or controlled release, protection of drugs from degradation and clearance, superior therapeutic effects, and…
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The FDA approved 50 novel drugs in 2021, including the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. Article by Asher Mullard - Nature Reviews Drug Discovery - 04 January 2022 The FDA’s approval count last year was in line with recent trends,…
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TORONTO/ANDERNACH, December 20, 2021 — PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, and LTS LOHMANN Therapie-Systeme AG (“LTS”), a leading pharmaceutical technology company, today announced they have entered into a process…
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