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Drug Substance Articles & Analysis
43 articles found
When multiple administrations occur polyethylene glycol gets recognized by the mononuclear phagocytic system as a foreign substance which activates the immune system and results in the fast clearance of the substance thus preventing the drug from reaching target cells. ...
In the ever-evolving world of pharmaceutical development, the quest to innovate and improve the delivery of drug substances remains a top priority. Among the many formulation strategies, oral liquid formulations hold a special place, offering alternatives particularly appealing for specific populations and addressing unique formulation challenges. ...
Pharmacokinetic studies serve as the foundation for understanding the drug's bioavailability – the degree and rate at which an administered drug reaches the systemic circulation. ...
In the pharmaceutical industry, maintaining stringent contamination control strategies is not just a regulatory obligation but a fundamental aspect of ensuring product safety and efficacy. The EU GMP Annex 1 outlines the importance of a Contamination Control Strategy (CCS) for sterile drug products, emphasizing the need for a structured approach to manage risks and maintain compliance. We ...
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 to the drug. ...
Certain HCPs can act as adjuvants to enhance the immune response to drugs. Some HCPs with proteolytic activity can also affect the stability and efficacy of drugs if they are not sufficiently removed or inactivated. ...
Pharmaceutical Analysis Pharmaceutical analysis is a branch of analytical chemistry that deals with the analysis of pharmaceutical substances, including drugs, their formulations, and their compatibility with various excipients. ...
The main considerations include optical chirality, polymorphism, impurities (product-related, process-related, free drugs and related substances, residual solvents, heavy metals), biological activity (target specific binding, affinity, effector function) and potency. ...
The NIR-PIT drug is not a cytotoxic substance, but a water-soluble phthalocyanine derivative.Dual Payload ADCAs resistance to ADC therapies emerges, combining one antibody with two or more different cytotoxic payloads provides options for the development of next-generation ADCs. ...
By identifying and tracking the presence of these substances, scientists can devise strategies to mitigate environmental risks. Forensic Investigations: Chromatography and mass spectrometry allow for the identification and analysis of illegal drugs, toxic substances, and explosive residues in forensic science. ...
The United States Pharmacopeia (USP) started updating around 4300 Monographs and 220 General Chapters with modern technology in 2010 [1]. During this time, ion chromatography (IC) also became a more popular analytical technique as it matured. Regulatory agencies now consider IC as an acceptable technology to analyze pharmaceuticals and biopharmaceuticals. ...
ByB&W Tek
Even low levels of total HCP impurities can adversely affect the properties of the drug. Some of these HCPs may elicit an immune response even at microinjection, and some may even be biologically active or toxic themselves, potentially altering the binding affinity and potency of the drug. ...
While formulating commonly used preparations, it's vital to examine the compatibility between APIs and excipients to select excipients that do not adversely effects the drug. Solid Dosage Forms Interactions between drug substances and excipients in solid dosage forms involve both physical and chemical interactions. The former can induce changes ...
With our CompassCDS, a powerful Chromatography Data System is available that brings 20 years of legacy and continuous development to your desktop to fit into any combination of laboratory and type of industry.This summarising article covers a range of Gas Chromatography applications, looking at the industries that we supply solutions to, providing the best results for your laboratory from a ...
Related substance inspection: It is necessary to control the content of related substances in certain drugs during drug inspection. ...
The Perinatology Research Branch (PRB) is the only Clinical Branch in the Division of Intramural Research (DIR) of the National Institutes of Health (NIH) to focus its research on human pregnancy and unborn children. It is currently housed at the Detroit Medical Center in Detroit, Michigan through a service contract. The Branch has thrived in this environment, earning a national and international ...
Pharmacology: a brief history Our search for medicines is nearly as old as humanity itself. Medicinal ingredients from plant, mineral, and animal sources were used for healing purposes since the earliest of advanced civilizations. Herbal remedies from China date back to a couple of thousand years ago, while indigenous populations have been relying on environmental sources for healing for several ...
ByB&W Tek
This is to say that relatively more drugs will enter the lymphatic circulation and at the same time avoid the first pass effect of the drug in the liver. ...
This is to say that relatively more drugs will enter the lymphatic circulation and at the same time avoid the first pass effect of the drug in the liver. ...
Pharmaceutical excipients are natural or synthetic substances formulated together with the active ingredients of the drug, whose purpose is to increase the formulations containing effective active ingredients or endow the active ingredients in the final dosage form with therapeutic effects, such as promoting drug absorption or solubility. ...