Results 1 to 10 of about 104,796 (175)

Navigating Drug–Drug Interactions in Clinical Drug Development: A Tutorial [PDF]

Clinical and Translational Science
This tutorial provides essential guidelines and insights, in addition to regulatory guidance, for the evaluation of drug–drug interactions (DDIs), with a focus on the tools and timing of assessment critical for effective management of inclusion/exclusion
Jesmin Lohy Das, Antoinette (Toni) Ajavon‐Hartmann, Virginia (Ginny) D. Schmith   +2 more
doaj   +2 more sources

Oncologists' reflections on patient rights and access to compassionate use drugs: A qualitative interview study from an academic cancer center.

PLoS ONE, 2021
The U.S. Food and Drug Administration (FDA) allows patients with serious illnesses to access investigational drugs for "compassionate use" outside of clinical trials through expanded access (EA) Programs.
Jeremiah Stout, Cambray Smith, Jan Buckner, Alex A Adjei, Mark Wentworth, Jon C Tilburt, Zubin Master   +6 more
doaj   +1 more source

Review of investigational drugs for coronavirus disease 2019

Journal of Education and Health Promotion, 2021
In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became evident in Wuhan, China, and then spread rapidly worldwide.
Dhruva Sharma, Neha Sharma, Preksha Sharma, Ganapathy Subramaniam   +3 more
doaj   +1 more source

Factors of feasibility: an interview study of physicians’ experiences of expanded access to investigational drugs in three countries

Humanities & Social Sciences Communications, 2021
Seriously ill patients who have exhausted all approved treatment regimens and who cannot be enrolled in clinical trials may resort to expanded access programmes in order to gain access to unapproved, investigational drugs. It seems that in some countries,
Stefan F. Vermeulen, Marjolijn Hordijk, Nikkie Aarts, Eline M. Bunnik   +3 more
doaj   +1 more source

Investigational Drugs for the COVID 19 Pandemic – A Concise Review [PDF]

Pharmaceutical Sciences, 2020
The present year saw the emergence of a pandemic Corona Virus Disease of 2019 (COVID 19). The unpreparedness for the pandemic and lack of drugs/vaccine against this virus has led to a high mortality rate across the world.
Reena Sherin Parveen, Sherya Hegde, Veena Nayak   +2 more
doaj   +1 more source

A two-year evaluation of the minutes of Investigational New Drug committee meetings

Perspectives in Clinical Research, 2021
Introduction: The Investigational New Drug (IND) committee advises the Drug Controller General of India on matters pertaining to clinical trials (CTs) of IND for clinical development.
Jeffrey Pradeep Raj, Nithya J Gogtay, Urmila M Thatte   +2 more
doaj   +1 more source

National landscape assessment of academic medical center support for expanded access to investigational products

Journal of Clinical and Translational Science, 2023
Expanded access (EA) provides a pathway for the clinical use of investigational products (drugs, biologics, and medical devices) for patients who are without satisfactory therapeutic options and for whom a clinical trial is not available.
Misty Gravelin, Joan E. Adamo, Sharon Ellison, Erika Segear, Amanda B. Parrish, Christine Deeter, Jennifer Hamill, Laurie Rigan, George A. Mashour, Kevin J. Weatherwax   +9 more
doaj   +1 more source

Repurposed and investigational disease-modifying drugs in osteoarthritis (DMOADs)

Therapeutic Advances in Musculoskeletal Disease, 2022
In spite of a major public health burden with increasing prevalence, current osteoarthritis (OA) management is largely palliative with an unmet need for effective treatment.
Win Min Oo, David J. Hunter
doaj   +1 more source

Efficacy and safety of compassionate use for rare diseases: a scoping review from 1991 to 2022

Orphanet Journal of Rare Diseases, 2023
Background Compassionate use is a system that provides patients with expedited access to drugs which has not yet been approved, but currently in clinical trials.
Jiayu Wu, Yang Yang, Jiaxin Yu, Luyao Qiao, Wei Zuo, Bo Zhang   +5 more
doaj   +1 more source

Expanding Patient Access to Investigational Drugs

JACC: Basic to Translational Science, 2018
Summary: With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic ...
Gail A. Van Norman, MD
doaj   +1 more source