In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...
New drug modalities, including oligonucleotides, bispecific antibodies, prodrugs, cell and gene therapies, and fusion proteins, offer new ways to treat human diseases once considered "untreatable." Cell and gene therapies have been around for years, but advancing...
Pathologists examine the causes and mechanisms of diseases and, in the world of drug development, that means collecting, processing and analyzing tissue for toxicity. Histotechnologists fix tissue samples onto slides, stain them to distinguish types of cells and cell...
The newest partnership between Quanterix and WuXi AppTec Laboratory Testing Division (LTD) integrates industry-leading instruments and reagents with world-class laboratory and technical staff to form the co-developed Simoa Joint Lab in Shanghai. Starting in 2021, drug...
Encountering challenges while developing a new drug is expected, but drug developers who understand the pitfalls are often better prepared to navigate them and emerge successfully. Nonclinical safety assessment is a highly complex and molecule-specific process, but...
We offer a true, single-platform, end-to-end solution that can be catered to your specific drug discovery and development needs – saving you money while providing industry-leading turnaround times. With solutions for both small- and large-molecule development, our...
Engaging the right partners at the right time is essential to drug developers and the success of their compound. We sat down with Grace Furman, small-molecule toxicology consultant at Paracelsus, Inc., to get her perspective on some of the most pressing challenges and...
Metabolites in safety testing (MIST) has become an integrated part of drug metabolism research in drug development, and is a widely discussed topic within the drug development industry. Recent guidance from the U.S. Food and Drug Administration (FDA) on safety...
The use of Internal Standards (IS) is essential to Liquid Chromatography-tandem Mass Spectrometric (LC-MS/MS) quantitative bioanalytical methods. Yet, there are no set methodologies or widely adopted criteria among laboratories for establishing and assessing Internal...
The development path for bringing new drugs and therapeutics to market requires extensive planning to meet the short- and long-term needs of products intended for global registration. Because international regulatory agencies may have different requirements for...
DMPK - A Key Step, Every Step of the Way Drug metabolism and pharmacokinetics (DMPK) is a crucial component in the success of your drug development – at every stage, from discovery to preclinical to clinical. DMPK studies set basic expectations of drug behavior, which...
Developing biologic solutions is a complex process, and bridging bioanalytical assays from preclinical to phase I clinical trials is a demanding step in advancing your therapeutic. While maneuvering through regulatory requirements and intensive testing, it is easy for...