drug safety Articles
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Early efficacy signals in ovarian cancer patients in ongoing Ph1 trial: Poster reporting findings presented at SITC 2020 Annual Meeting
ENB Therapeutics reports preliminary data from the ongoing Phase 1/2 trial assessing the safety and efficacy of lead product ENB-003 in combination with pembrolizumab. Safety data are encouraging with no significant drug related safety events from the first 3 dosing cohorts. Best overall responses from the first 6 patients include 2 disease stabilizations and 1 confirmed partial response. The ...
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An In-depth Analysis of hERG (IKr, Kv11.1): Its Function, Role, and Importance
Introduction hERG, which stands shorthand for the human Ether-à-go-go-Related Gene, generates the protein responsible for a certain type of potassium channel in the human heart, denoted as IKr or Kv11.1. The role of this potassium channel is fundamental for normal cardiac function, playing a vital role in the termination of the cardiac action potential and ultimately contributing to the ...
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Some Basic Facts about Forced Degradation Test for Drug Development
Benefits of forced degradation test The degradation pathway of the drug is closely related to the molecular structure of the drug. The ester group or amide bond in the molecular structure may be hydrolyzed under acid-base catalysis conditions. Provide support for drug safety. When toxicologically relevant impurities are not readily available, toxicological evaluation of samples degraded to a ...
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Understanding API-Excipient Interactions in Pharmaceutical Formulations
Pharmaceutical formulations consist of active pharmaceutical ingredients (APIs) and excipients. Appropriate excipient selection is critical to the final quality of pharmaceutical products. When designing pharmaceutical preparations, the choice of excipients should not only consider the dosage form factors and excipient functions but also the interaction and compatibility between APIs and ...
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What Clinical Trial Speed Factors Can Sponsors Actually Control?
When promising drug candidates are identified for further investigation in clinical trials, sponsor companies are usually optimistic about outcomes. But there are times, when after years of sunk effort and resources, clinical trials fail to bring a viable drug to market. Frequently, a drug fails for safety or efficacy reasons that are beyond a sponsor’s control. However, to some degree, ...
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Distribution of Oxytetracycline residues in eggs from orally administered hens
Twenty five-week old hens (n = 6) were administered with an oral dose of 75 mg of Oxytetracycline (OTC) hydrochloride per day per head for five consecutive days and its residues in eggs as well as breast, leg and liver tissues were analysed by a high-performance liquid chromatography-ultraviolet visible detection (HPLC-UV) technique. The highest OTC residue concentration in egg white (0.5944 µg ...
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Accelerating Drug Discovery: The Power of Protein-Small Molecule Docking
Protein-small molecule docking is a computational technique used to predict the binding mode of a small molecule to a protein. This technique has emerged as a powerful tool in drug discovery and design. Docking services can be used to identify potential drug candidates, optimize the activity and selectivity of drugs, predict the toxicity of drugs, and design new proteins with specific functions. ...
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How to Apply In Vitro DMPK Services to Support Drug Development and ADMET Study
Drug development is a complex and multifaceted process that involves extensive research and testing to ensure safety, efficacy and quality for human use. One critical element in the drug development process is drug metabolism and pharmacokinetics (DMPK), which refers to how a drug is absorbed, distributed, metabolized, and excreted (ADME) from the body. In vitro DMPK services, along with ...
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How to Apply In Vitro DMPK Services to Support Drug Development and ADMET Study
Drug development is a complex and multifaceted process that involves extensive research and testing to ensure safety, efficacy and quality for human use. One critical element in the drug development process is drug metabolism and pharmacokinetics (DMPK), which refers to how a drug is absorbed, distributed, metabolized, and excreted (ADME) from the body. In vitro DMPK services, along with ...
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How much do animal models play a role in drug development?
Published by Vijay K Singh and Thomas M Seed on September 3, 2021, in Expert Opinion on Drug Discovery and deals with the necessity of animal models for modern drug research in the direction of animal strains, animal models, requirements, and pathways for developing new drugs. The use of experimental animal models in drug development aids in the understanding of disease and/or related conditions' ...
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Understanding the Importance of Preclinical Animal Models in Drug Development
In the world of pharmaceuticals, developing safe and effective drugs is a complex and time-consuming process. Before a new drug candidate can progress to clinical trials and ultimately reach the market, it needs to undergo rigorous testing in various model systems to assess its efficacy and safety. One critical component of this evaluation is the use of preclinical animal models. Preclinical ...
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The Key Factor of Excellent Drug Efficacy: Chemical Structure of Drug
How to keep the drug active and give full play to its therapeutic effect has always been the primary problem to be solved by researchers in the field of pharmacy. It is a very complex process from drug administration to the generation of drug efficacy. Scientists have divided this process into three phases: Pharmaceutical phase, pharmacokinetic phase and pharmacodynamic phase. Only by ensuring ...
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High precision single use temperature recorder for pharmaceuticals
Many drugs are temperature sensitive, and higher or lower temperatures will affect their quality and safety. The storage and transportation of medicines require cold chain management and temperature monitoring. The high-precision single use temperature recorder is very suitable for use in the pharmaceutical cold chain. It has low cost, small space occupation, high accuracy, and meets ...
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Predicting cardiotoxicity with engineered 3D human cardiac tissue models
Cardiovascular safety liabilities caused 52.3 % of 44 marketed data from 1980 to 2011, and cardiovascular disease remains the leading cause of death globally, yet only 8.7% of cardiovascular drugs successfully pass clinical trials. These statistics demonstrate the need to address a patient’s specific genetic make-up and phenotype by adopting a personalized treatment methodology for ...
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How to Select Excipients in Drug Formulation?
The purpose of formulation development is to ensure that the drug is safe, effective, stable, and convenient to use. If the dosage form is improperly selected and if the prescription and process design are unreasonable, it will have a certain impact on the quality of the drug product, and even affect the drug’s efficacy and safety. Therefore, formulation research occupies a very important ...
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Improved 3D Liver Model Could Forever Change Drug Testing – Allevi Author
The liver plays an incredibly important role in the human body by metabolizing drugs and other compounds. Developing accurate in vitro liver models to study is a critical step in better understanding the biological dynamics of our bodies and removing our dependence on animal models. In their recent publication, Allevi authors Marie Cuvellier, Frédéric Ezan, Hugo Oliveira, Sophie ...
By Allevi, Inc.
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What Is Drug Stability Analysis? - Basics You Need to Know in Drug Discovery
The basic requirements of pharmaceutical preparations are safety, efficacy, and stability. Drug stability means that a drug product should maintain the same properties and characteristics as it was at the time of production and within the specified time frame. The stability of pharmaceutical preparations directly affects the effectiveness and safety of drugs. Therefore, it is of great ...
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Bispecific Antibodies and Bispecific Antibody ADCs
With the rapid development of antibody-drug conjugate (ADC), more and more companies have entered the field of ADC research and development, and various types of ADC technologies and branches have emerged. Bispecific antibody conjugates (BsAb ADCs) are one of the emerging new technologies. The high specificity of bispecific antibodies enables more precise targeting of tumor cells. On the other ...
By BOC Sciences
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The Five Factors of Smart Laboratory Success
The Five Factors Research organizations are under pressure to cut costs while maintaining or increasing throughput. To improve their operations, many laboratories are considering investments in data management or support and automation systems like ELNs, LIMS or Robotics/HTS. Whatever the change that is introduced, there are many pitfalls on the way to delivery, roll-out and successful ...
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A hybrid modeling approach for assessing mechanistic models of small molecule partitioning in vivo using a machine learning integrated modeling platform
Prediction of the first-in-human dosing regimens is a critical step in drug development and requires accurate quantitation of drug distribution. Traditional in vivo studies used to characterize clinical candidate’s volume of distribution are error-prone, time and cost intensive and lack reproducibility in clinical settings. The paper demonstrates how a computational platform integrating ...
By VeriSIM Life
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