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Drug Hd Safety Articles & Analysis
33 articles found
In preclinical respiratory studies, traditional methods like plethysmography often require animal restraint and extensive acclimation, limiting their ability to capture dynamic respiratory changes. To overcome these challenges, IPS Therapeutique Inc. validated a novel telemetry-based technique for continuous monitoring of intrapleural pressure and respiratory patterns in conscious, freely ...
Introduction PEGylation, the process of attaching polyethylene glycol (PEG) chains to therapeutic molecules, has become a cornerstone in pharmaceutical development. This technique improves the pharmacokinetic and pharmacodynamic properties of drugs, enhancing their stability, solubility, and circulation time while reducing immunogenicity. Since its first FDA-approved application in 1990 with ...
Pharmaceutical manufacturers face growing challenges in ensuring product quality, maintaining regulatory compliance, and safeguarding against counterfeit drugs. Near-infrared (NIR) spectroscopy is an important tool in this arena, offering rapid, non-destructive analysis for raw material identification, impurity detection, and counterfeit screening. By integrating NIR spectroscopy into quality ...
Introduction Cytochrome P450 (CYP) refers to a family of enzymes that play a fundamental role in the metabolism of various substances within the body, particularly drugs, toxins, and endogenous compounds. These enzymes are crucial for the detoxification processes in the liver and affect the pharmacokinetics of numerous medications. Understanding the function and importance of cytochrome P450 is ...
Nuclear receptors are a class of proteins that play a vital role in cellular communication, gene expression, and overall homeostasis within the body. They act as transcription factors, responding to various stimuli, including hormones, nutrients, and even environmental agents. Due to their crucial roles in physiological and pathological processes, nuclear receptors have emerged as significant ...
In the realm of pharmaceutical research and development, ADME testing services play a pivotal role in evaluating the pharmacokinetics of drug candidates. ADME stands for Absorption, Distribution, Metabolism, and Excretion, which are critical processes that determine the fate of a drug within the body. Effectively assessing these parameters is essential for ensuring the safety, efficacy, and ...
Pharmacokinetics (PK) and pharmacodynamics (PD) are two fundamental pillars in the field of pharmacology and drug development. Understanding their intricate interplay is essential for determining the efficacy and safety of therapeutic compounds. When studied in living organisms, this relationship is referred to as in vivo PK/PD, a discipline that provides invaluable insights into drug behavior ...
The world of drug development has long been marked by the rigorous assessment of cardiac safety. Recognizing the need for a more accurate and efficient evaluation system, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative emerged. At the heart of this initiative are CiPA Translational Assays, designed to improve the prediction of drug-induced cardiac arrhythmias. Understanding the ...
HCEC-12 is a well-established human corneal epithelial cell line derived from human corneal tissue. It plays a crucial role in ocular research, particularly for studies related to corneal physiology, wound healing, and the pathogenesis of various ocular diseases. This article delves into the characteristics, applications, and significance of the HCEC-12 cell line in biological and medical ...
Medical advancement relies on clinical trials, which are essential for the development of safe and effective innovative treatments. However, the success and general applicability of these treatments heavily depend on the diversity of the participants involved¹?³. This blog explores the importance of achieving data diversity in clinical trials to enhance clinical trial results and ...
The scientific realm behind the development and evaluation of therapeutic drugs, pesticides, industrial and environmental chemicals profoundly relies on a field of research called Pharmacokinetic/Toxicokinetic (PK/TK) studies. These investigations provide substantial information on how an organism affects a substance, delineating vital zones of absorption, distribution, metabolism, and excretion. ...
Glycosylation impurities are a type of chemical commonly encountered in biochemical, medical, and pharmaceutical chemistry research. The presence of these impurities can affect the efficacy, safety, and stability of drugs. Therefore, the detection and analysis of glycosylation impurities are crucial in ensuring the quality and therapeutic effectiveness of pharmaceutical products.What are ...
Drug antibody testing is a laboratory testing method specifically designed to evaluate the immune response of the human body to certain drugs. This test is commonly used to monitor a patient's immune response to biological agents or other drugs, especially in the treatment of chronic diseases such as autoimmune diseases, certain cancers, and inflammatory diseases. The principle of drug antibody ...
Circular Dichroism (CD) uses the absorption properties of optically active substances to analyze the molecular structure of drugs. It has very valuable applications in drug analysis, including:1. Identification of Drug StereochemistryMany drug molecules are chiral, and their activity, metabolism, and toxicity can significantly differ due to stereochemistry. CD can differentiate the different ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...