Drug Evaluation Articles & Analysis: Older
28 articles found
Knockin cell line generation represents a pivotal advancement in genetic engineering, providing vital tools for biological research and therapeutic development. This process involves the integration of specific DNA sequences into precise loci within the genome, allowing scientists to explore gene function, model diseases, and develop new treatments. Understanding Knockin Cell Line Generation At ...
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 ...
Antibody drugs are a type of drugs that treat diseases through artificially synthesized antibodies, which bind specifically to target molecules for therapeutic purposes. Common types of antibody drugs include monoclonal antibodies, artificially synthesized antibody fragments, immunotoxins, and antibody-drug conjugates, etc. Antibody drugs have shown significant therapeutic effects in the ...
Recombinant protein drugs are protein-based therapeutic drugs which are produced by using DNA recombination technology or other biotechnological methods. These drugs include cytokines, peptide hormones, recombinant enzymes, monoclonal antibodies, and fusion proteins. Compared to traditional low-molecular-weight synthetic drugs, recombinant protein drugs have advantages such as high specificity, ...
Sialic acid proteins are a special type of glycoproteins, characterized by the presence of sialic acid at the end of the sugar chain. Sialic acid is a biologically important sugar molecule that plays a crucial role in many intercellular interactions, including cell recognition, adhesion and signal transduction. Therefore, the detection of sialic acid proteins holds significant value in disease ...
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. ...
When we look at the awe-inspiring architecture of life at the cellular level, one of the most intriguing and essential features is the cytoskeleton. This dynamic network of protein filaments provides structure, facilitates movement, and enables intracellular transport. Advances in technology have revolutionized our understanding of the cytoskeleton and have expanded the possibilities of ...
Antibody-drug conjugates (ADCs) are a new class of drugs that combine the advantages of both antibodies and small molecule toxins. Compared with traditional cytotoxins, ADCs have the advantages of strong targeting, less toxic side effects, etc. They can accurately target tumor cells, reduce side effects, and improve the therapeutic effect.ADC drugs are mainly composed of monoclonal antibodies, ...
Peptide drugs are bioactive molecules formed by connecting multiple amino acids through peptide bonds. Generally, they are formed by connecting 10-100 amino acids, with a relative molecular mass lower than 10000. Most peptide drugs come from endogenous peptides or natural peptides, so they have no or little side effects on the human body. Compared to protein drugs, peptide drugs also have ...
Since antibody-drug conjugates (ADCs) have the molecular characteristics of both small molecule and macromolecule therapeutic drugs, when choosing analytical methods, the typical ones used for both should all be considered. There are many different molecules in ADCs, and the difference between these molecules lies in the drug-to-antibody ratio (DAR) value and/or the site where the antibody binds ...
MtoZ Biolabs, leveraging high-precision mass spectrometry technology in conjunction with a chemical proteomics platform, provides you with high quality Collagen Analysis services and other Medical Device services. As a leading biotechnology company, MtoZ Biolabs is committed to providing comprehensive, one-stop CRO testing services to scientific research institutions and pharmaceutical companies ...
Stroke, also known as transient ischemic attack or cerebrovascular accident, is an acute brain disease. Usually, a sudden rupture of a blood vessel in the brain or a blockage of a blood vessel that prevents blood from flowing to the brain can cause damage to brain tissue, resulting in a stroke. Long-term strokes can lead to brain damage, disability and even death. The brain serves as a ...
Flow cytometry (FC) is an important tool for analyzing complex pathways and responses of single cells, which can track cell phenotypes and functions in multiple dimensions. It is also increasingly applied in drug development. FC not only can detect intracellular and extracellular components, but also detect soluble analytes in serum or plasma samples, such as cytokines, drug complexes, or ...
CD Genomics, a well-established leader in transcriptome solutions, is pleased to announce the introduction of Ribosome Profiling technology. This innovative technique promises to provide valuable insights into gene expression, protein synthesis, and regulation, offering potential advancements in the field of RNA translation research. Ribo-seq is a cutting-edge high-resolution sequencing ...
Microencapsulation technology has revolutionized drug delivery systems, allowing for the protection and controlled release of therapeutic agents. Microcapsules, tiny spherical structures capable of encapsulating drugs, offer numerous advantages in terms of stability, targeted delivery, and improved patient outcomes. In this article, we will delve into the methods involved in preparing drug ...
The FDA's Center for Drug Evaluation and Research (CDER) regulatory approval of a total of 26 NME (New Molecular Entity) drugs in the first half of 2023. It is worth noting that the 26 drugs approved include 4 peptide drugs, accounting for 15% of the total. In the past 2022, the FDA has approved only three peptide drugs: Tirzepatide, Lutetium 177Lu Vipivotide Tetraxetan and Terlipressin, of which ...
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 ...
In the field of biomedical research, immortalized cell lines have proven to be invaluable tools for a wide range of studies. These cell lines, derived from primary cells, possess the unique ability to undergo continuous division, providing researchers with a sustainable and consistent source of cells for experimentation. Additionally, immortalized cell lines have the advantage of maintaining the ...
Recently, in the renowned academic journal Nature Medicine, the Kimmel Cancer Center at Johns Hopkins University published Phase 2 clinical results regarding enoblituzumab, a monoclonal antibody targeting B7-H3, for the treatment of prostate cancer. The results demonstrate that enoblituzumab can successfully induce the body's anti-cancer activity, showing favorable therapeutic efficacy and safety ...
The biologics license application (BLA) has been accepted for Enfortumab Vedotin for the treatment of locally advanced or metastatic urothelial carcinoma in patients who have previously received PD-1/PD-L1 inhibitors and platinum-containing chemotherapy. Enfortumab Vedotin is the first domestically submitted targeted antibody-drug conjugate that specifically targets Nectin-4. Enfortumab ...