Results 21 to 30 of about 272,653 (310)

Mechanistic modeling of drug products applied to the skin: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
The development of a generic drug product involves demonstrating that there is no significant difference in the rate and extent to which the active ingredient becomes available at the site of action, relative to the reference listed drug product.
Eleftheria Tsakalozou, Khondoker Alam, Priyanka Ghosh, Jessica Spires, Sebastian Polak, Lanyan Fang, Srinivasa Sammeta, Ping Zhao, Sumit Arora, Sam G. Raney   +9 more
doaj   +1 more source

Avobenzone, Guaiazulene and Tioxolone identified as potent autophagy inducers in a high-throughput image based screen for autophagy flux

Autophagy Reports, 2022
Autophagy is a conserved intracellular degradation pathway that is essential for maintaining cellular homeostasis. Given its critical role in several disease conditions, recent studies are focussed on identifying drugs/small molecules with autophagy ...
Surendra Kumar Prajapat, Chandru Subramani, Puja Sharma, Sudhanshu Vrati, Manjula Kalia   +4 more
doaj   +1 more source

A Review of FDA-Approved Antiparasitic Drugs in USA for Sheep and Goats: Their Synthesis and Pharmaceutical Use [PDF]

Trends in Pharmaceutical Sciences, 2023
This review describes the Food and Drug Administration (FDA)-approved antiparasitic drugs for sheep and goats in the USA updated to 2021. The emerging drug resistance is posing a significant burden for the treatment of parasitic infections in these small
Davide Benedetto Tiz, Črtomir Podlipnik
doaj   +1 more source

FDA-Approved Small Molecules in 2022: Clinical Uses and Their Synthesis

Pharmaceutics, 2022
This review describes the recently FDA-approved drugs (in the year 2022). Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient or as part of a combination.
Davide Benedetto Tiz, Luana Bagnoli, Ornelio Rosati, Francesca Marini, Claudio Santi, Luca Sancineto   +5 more
doaj   +1 more source

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
MORETTI, Ugo, De Ponti F., Sturkenboom, M, Sturkenboom, M.C.J.M. (Miriam), De Ponti, F, Behr, E.R. (Elijah), Koci A, Spina, E, Sturkenboom M, Ariola Koci, Poluzzi E, Spina E, Raschi, E. (Emanuel), Ponti, F. (Fabrizio) de, Ugo Moretti, Spina, E. (Edoardo), Poluzzi, E, POLUZZI, ELISABETTA, Koci, A. (Ariola), Behr ER, Koci, A, Elijah R. Behr, Elisabetta Poluzzi, Poluzzi, E. (Elisabetta), Sturkenboom, MCJM, Moretti, U. (Ugo), Fabrizio De Ponti, KOCI, ARIOLA, Moretti, U, Emanuel Raschi, Raschi, E, Miriam Sturkenboom, DE PONTI, FABRIZIO, Moretti U, RASCHI, EMANUEL, Behr, ER, Raschi E, Edoardo Spina   +37 more
core   +1 more source

Patient-reported outcomes in breast cancer FDA drug labels and review documents

Journal of Patient-Reported Outcomes, 2021
Background Patient-reported outcomes (PROs) can provide valuable information about drug benefit-risk tradeoffs from the patient perspective and are particularly important to patients with breast cancer due to its symptoms and adverse events from breast ...
Kyungwan Hong, Kayleigh R. Majercak, Ester Villalonga-Olives, Eleanor M. Perfetto   +3 more
doaj   +1 more source

Comprehensive chemo-profiling of coumarins enriched extract derived from Aegle marmelos (L.) Correa fruit pulp, as an anti-diabetic and anti-inflammatory agent

Saudi Pharmaceutical Journal, 2023
Aegle marmelos (L.) Correa is an Indian medicinal plant known for its vast therapeutic activities. In Ayurveda, the plant is known to balance “vata,” “pitta,” and “kapha” dosh.
Ritu Tiwari, Smita Mishra, Gnanabhaskar Danaboina, Gaurav Pratap Singh Jadaun, M. Kalaivani, Vivekanandan Kalaiselvan, Mahaveer Dhobi, Rajeev S Raghuvanshi   +7 more
doaj   +1 more source

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

OTO Open, 2022
Objective To evaluate new medical devices and drugs pertinent to otolaryngology–head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Data Sources Publicly available FDA device and drug approvals from ENT (ear, nose,
Alexander M. Choi MD, Michael J. Brenner MD, Daniel Gorelik, Isaac D. Erbele MD, Matthew G. Crowson MD, PhD, Prajoy Kadkade MD, Masayoshi Takashima MD, Peter L. Santa Maria MBBS, PhD, Robert S. Hong MD, Austin S. Rose MD, MBA, Benjamin T. Ostrander MD, MSE, Cyrus C. Rabbani MD, Robert J. Morrison MD, Philip A. Weissbrod MD, Alan D. Tate MD, Joshua J. Kain MD, Ioan A. Lina MD, Scott R. Shaffer MD, Omar G. Ahmed MD   +18 more
doaj   +1 more source

Large numbers of patients are needed to obtain additional approvals for new cancer drugs: A retrospective cohort study

Scientific Reports, 2023
Patients endure risk and uncertainty when they participate in clinical trials. We previously estimated that 12,217 patient-participants are required to bring a new cancer drug to market.
Charlotte Ouimet, Nora Hutchinson, Catherine Wang, Carol Matyka, Joseph C. Del Paggio, Jonathan Kimmelman   +5 more
doaj   +1 more source

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context

The Lancet Regional Health. Americas, 2023
Summary: Background: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings.
Adriana M. Ivama-Brummell, Fernanda L. Marciniuk, Anita K. Wagner, Claudia G.S. Osorio-de-Castro, Sabine Vogler, Elias Mossialos, Carla L. Tavares-de-Andrade, Huseyin Naci   +7 more
doaj   +1 more source