Results 1 to 10 of about 945,046 (251)

Approval success rates of drug candidates based on target, action, modality, application, and their combinations

open access: yesClinical and Translational Science, 2021
The current success rate of a drug candidate, from the beginning of the clinical trial to receiving marketing approval, is about 10%–20%, and it has not changed during the past few decades. Therefore, pharmaceutical companies are under pressure to select
Shingo Yamaguchi   +2 more
doaj   +1 more source

Antibody-drug conjugates in cancer therapy: current advances and prospects for breakthroughs

open access: yesFrontiers in Cell and Developmental Biology
Antibody-drug conjugates (ADCs), often referred to as “intelligent biological missiles,” have garnered significant attention in the rapidly evolving landscape of cancer therapy. ADCs represent a sophisticated approach by integrating monoclonal antibodies
Dan Wu   +9 more
doaj   +1 more source

A review of the regulatory framework for personalized bacteriophages registration

open access: yesВопросы вирусологии, 2020
The increasing trend in antimicrobial resistance of pathogenic bacteria dictates the need for alternative solutions. Bacteriophages are bacterial viruses that kill their hosts during the lifecycle.
N. N. Landyshev   +5 more
doaj   +1 more source

In vitro toxicity model: Upgrades to bridge the gap between preclinical and clinical research

open access: yesBiomolecules & Biomedicine, 2020
The Centers for Disease Control and Prevention (CDC) provides extensive data that indicate our need for drugs to maintain human population health. Despite the substantial availability of drugs on the market, many patients lack specific drugs.
Eneko Madorran   +3 more
doaj   +1 more source

The drug approval tactician [PDF]

open access: yesNature Reviews Drug Discovery, 2003
Regulatory affairs in the pharmaceutical industry is both a familiar and unfamiliar world. The industry is well known as being one of the most highly regulated, revolving around the approval of new compounds that emerge from the drug development pipeline by national or multinational regulatory bodies.
openaire   +2 more sources

Global Regulatory Perspectives on Clinical Data Management: A Comparative Review of Various Regulatory Agencies

open access: yesNational Board of Examinations Journal of Medical Sciences
Background: Clinical trials are conducted with a set of ethical standards, patient safety measures, and scientific scrutiny. Clinical Data Management Systems have evolved over time, shaped by historical milestones, technological advancement, and ...
Thrupthi D L   +4 more
doaj   +1 more source

Real-World Outcomes of Incurable Cancer Patients Treated with Unlisted Anticancer Treatments in an Academic Center in Quebec, Canada

open access: yesCurrent Oncology
Medical oncology is a rapidly evolving field, with new medications being discovered yearly, contributing to increased survival rates. However, accessing drugs in a timely manner can be challenging. In Quebec, Canada, a physician can prescribe an unlisted
Adam Miller   +4 more
doaj   +1 more source

A descriptive study of new drug approvals during 2017–2021 and disease morbidity and mortality patterns in India

open access: yesPerspectives in Clinical Research
Aim: Studies show the presence of a mismatch between drug research and disease burden. A study conducted in the European Union found that new drug development was restricted to certain diseases.
Urvashi Gupta   +2 more
doaj   +1 more source

New frontiers in oncolytic viruses: optimizing and selecting for virus strains with improved efficacy

open access: yesBiologics: Targets & Therapy, 2018
Kenneth Lundstrom PanTherapeutics, Lutry, Switzerland Abstract: Oncolytic viruses have demonstrated selective replication and killing of tumor cells.
Lundstrom K
doaj  

Assessment of the implementation of accelerated drug marketing registration procedures for antineoplastic and immunomodulating agents in China: based on 2016–2022 review data

open access: yesFrontiers in Pharmacology
Objective:Since 2016, China has successively implemented Accelerated Drug Marketing Registration Procedures (ADMRPs) for drugs, including Breakthrough Therapy Drug (BTD), Conditional Approval (CA), and Priority Review and Approval (PRA), which have ...
Yipeng Lan   +7 more
doaj   +1 more source

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