Drug development
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Therapeutic peptides: Historical perspectives, current development trends, and future directions Open
Peptide therapeutics have played a notable role in medical practice since the advent of insulin therapy in the 1920s. Over 60 peptide drugs are approved in the United States and other major markets, and peptides continue to enter clinical …
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Targeting microbial biofilms: current and prospective therapeutic strategies Open
Biofilm formation is a key virulence factor for a wide range of microorganisms that cause chronic infections. The multifactorial nature of biofilm development and drug tolerance imposes great challenges for the use of conventional antimicr…
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oncoPredict: an R package for predicting <i>in vivo</i> or cancer patient drug response and biomarkers from cell line screening data Open
Cell line drug screening datasets can be utilized for a range of different drug discovery applications from drug biomarker discovery to building translational models of drug response. Previously, we described three separate methodologies t…
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Three-Dimensional in Vitro Cell Culture Models in Drug Discovery and Drug Repositioning Open
Drug development is a lengthy and costly process that proceeds through several stages from target identification to lead discovery and optimization, preclinical validation and clinical trials culminating in approval for clinical use. An im…
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Estimation of clinical trial success rates and related parameters Open
Previous estimates of drug development success rates rely on relatively small samples from databases curated by the pharmaceutical industry and are subject to potential selection biases. Using a sample of 406 038 entries of clinical trial …
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Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018 Open
Importance The mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion. Objective To estimate the research and development investment required to bring a new therap…
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Biomarker definitions and their applications Open
Biomarkers are critical to the rational development of medical therapeutics, but significant confusion persists regarding fundamental definitions and concepts involved in their use in research and clinical practice, particularly in the fie…
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Research and Development on Therapeutic Agents and Vaccines for COVID-19 and Related Human Coronavirus Diseases Open
Since the outbreak of the novel coronavirus disease COVID-19, caused by the SARS-CoV-2 virus, this disease has spread rapidly around the globe. Considering the potential threat of a pandemic, scientists and physicians have been racing to u…
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Human organs-on-chips for disease modelling, drug development and personalized medicine Open
The failure of animal models to predict therapeutic responses in humans is a major problem that also brings into question their use for basic research. Organ-on-a-chip (organ chip) microfluidic devices lined with living cells cultured unde…
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History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology Open
Background: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered bi…
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Treatment of muscle‐invasive and advanced bladder cancer in 2020 Open
Bladder cancer accounts for nearly 170,000 deaths worldwide annually. For over 4 decades, the systemic management of muscle‐invasive and advanced bladder cancer has primarily consisted of platinum‐based chemotherapy. Over the past 10 years…
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Challenges and strategies in anti-cancer nanomedicine development: An industry perspective Open
Successfully translating anti-cancer nanomedicines from pre-clinical proof of concept to demonstration of therapeutic value in the clinic is challenging. Having made significant advances with drug delivery technologies, we must learn from …
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Computational approaches streamlining drug discovery Open
Computer-aided drug discovery has been around for decades, although the past few years have seen a tectonic shift towards embracing computational technologies in both academia and pharma. This shift is largely defined by the flood of data …
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Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials: Table 1. Open
Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and d…
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Current Trends and Challenges in the Clinical Translation of Nanoparticulate Nanomedicines: Pathways for Translational Development and Commercialization Open
The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of att…
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The target landscape of clinical kinase drugs Open
An atlas for drug interactions Kinase inhibitors are an important class of drugs that block certain enzymes involved in diseases such as cancer and inflammatory disorders. There are hundreds of kinases within the human body, so knowing the…
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Therapeutic target database 2020: enriched resource for facilitating research and early development of targeted therapeutics Open
Knowledge of therapeutic targets and early drug candidates is useful for improved drug discovery. In particular, information about target regulators and the patented therapeutic agents facilitates research regarding druggability, systems p…
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Network-based prediction of drug combinations Open
Drug combinations, offering increased therapeutic efficacy and reduced toxicity, play an important role in treating multiple complex diseases. Yet, our ability to identify and validate effective combinations is limited by a combinatorial e…
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Molecular Actions of PPARα in Lipid Metabolism and Inflammation Open
Peroxisome proliferator-activated receptor α (PPARα) is a nuclear receptor of clinical interest as a drug target in various metabolic disorders. PPARα also exhibits marked anti-inflammatory capacities. The first-generation PPARα agonists, …
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Artificial Intelligence in Pharmaceutical Technology and Drug Delivery Design Open
Artificial intelligence (AI) has emerged as a powerful tool that harnesses anthropomorphic knowledge and provides expedited solutions to complex challenges. Remarkable advancements in AI technology and machine learning present a transforma…
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The Potential for microRNA Therapeutics and Clinical Research Open
As FDA-approved small RNA drugs start to enter clinical medicine, ongoing studies for the microRNA (miRNA) class of small RNAs expand its preclinical and clinical research applications. A growing number of reports suggest a significant uti…
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Cyclic peptide therapeutics: past, present and future Open
Cyclic peptides combine several favorable properties such as good binding affinity, target selectivity and low toxicity that make them an attractive modality for the development of therapeutics. Over 40 cyclic peptide drugs are currently i…
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Alzheimer's disease drug development pipeline: 2019 Open
Introduction Alzheimer's disease (AD) has few available treatments, and there is a high rate of failure in AD drug development programs. Study of the AD drug development pipeline can provide insight into the evolution of drug development a…
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Alzheimer's disease drug development pipeline: 2018 Open
Introduction Treatments for Alzheimer's disease (AD) are needed due to the growing number of individuals with preclinical, prodromal, and dementia forms of AD. Drug development for AD therapies can be examined by inspecting the drug develo…
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Plant-Derived Natural Products: A Source for Drug Discovery and Development Open
For thousands of years, nature has been a source of medical substances, and an astounding numeral of contemporary remedies have been identified from natural origins. Plants have long been used as folk herbal medicines to treat various diso…
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The global preclinical antibacterial pipeline Open
Antibacterial resistance is a great concern and requires global action. A critical question is whether enough new antibacterial drugs are being discovered and developed. A review of the clinical antibacterial drug pipeline was recently pub…
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A Comprehensive Review on Current Advances in Peptide Drug Development and Design Open
Protein–protein interactions (PPIs) execute many fundamental cellular functions and have served as prime drug targets over the last two decades. Interfering intracellular PPIs with small molecules has been extremely difficult for larger or…
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Drug discovery and development: Role of basic biological research Open
This article provides a brief overview of the processes of drug discovery and development. Our aim is to help scientists whose research may be relevant to drug discovery and/or development to frame their research report in a way that appro…
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Are drug targets with genetic support twice as likely to be approved? Revised estimates of the impact of genetic support for drug mechanisms on the probability of drug approval Open
Despite strong vetting for disease activity, only 10% of candidate new molecular entities in early stage clinical trials are eventually approved. Analyzing historical pipeline data, Nelson et al. 2015 (Nat. Genet.) concluded pipeline drug …
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Alzheimer's disease drug development pipeline: 2022 Open
Introduction Alzheimer's disease (AD) represents a global health crisis. Treatments are needed to prevent, delay the onset, slow the progression, improve cognition, and reduce behavioral disturbances of AD. We review the current clinical t…