drug distribution Articles
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What’s the 2019 DSCSA Requirement and Why Was it Delayed?
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA), which was enacted to enhance FDA’s ability to protect consumers from exposure to potentially harmful drugs. The act outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. New requirements ...
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What’s Next for DSCSA Dispenser Requirements?
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA) and is designed to protect consumers from potentially harmful drugs. New requirements roll out on November 27th of each year. Each new requirement progresses toward building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United ...
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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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6 Best Practices to Help Achieve DSCSA Compliance
Many hospitals struggle to achieve optimal compliance with the Drug Supply Chain Security Act (DSCSA). The challenge to comply seems to come from an incomplete or inaccurate understanding of the regulations, which is understandable given the Act’s complexity. DSCSA was put in place to protect consumers from harmful drugs, such as those that are stolen or contaminated. The Act outlines ...
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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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How to Prepare Nano-vesicles for Encapsulating Protein Drugs?
Nano-vesicles, also known as liposomes, have emerged as promising drug delivery systems due to their unique structure and properties. These tiny spherical lipid bilayers can encapsulate various therapeutic agents, including protein drugs. In this article, we will explore the process of preparing nano-vesicles for encapsulating protein drugs, as well as the advantages of utilizing this innovative ...
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CMC Regulatory Considerations for ADCs
Antibody drug conjugates (ADCs) are a new class of biopharmaceuticals that use monoclonal antibodies to target tumor cells to deliver potent cytotoxic drugs. So far, a total of 15 ADC drugs have been approved worldwide, of which the FDA has approved 13 ADCs for various cancers, including Adcetris®, Kadcyla®, Besponsa®, Mylotarg®, Lumoxiti®, Polivy®, Padcev®, Enhertu ®, Trodelvy® and Blenrep®. As ...
By BOC Sciences
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Comparison and Analysis of SMDC, ADC, and DAC
In order to more effectively deliver chemotherapy drugs, Small Molecule Drug Conjugates (SMDC), Antibody Drug Conjugates (ADC), and Degradation Antibody Conjugates (DAC) have been successively explored and developed, enhancing the therapeutic index while providing selective delivery. What are their similarities and differences? What are their respective advantages? What is the current status of ...
By BOC Sciences
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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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Bioconjugation Strategies for Enhancing Drug Delivery and Therapeutic Efficacy
In recent years, bioconjugation has emerged as a powerful strategy for improving drug delivery and enhancing therapeutic efficacy. By linking drugs to various biological entities, such as proteins, antibodies, nanoparticles, or targeting moieties, bioconjugation enables precise and targeted delivery of therapeutic agents to desired sites. This article aims to provide an overview of different ...
By BOC Sciences
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Temperature Excursion Management in Pharmaceutical Storage
The quality of pharmaceuticals relies on the environment controls during its storage and handling. Every pharmaceutical item ought to be taken care of and stored under manufacturer-recommended storage condition marked on data information sheet or packaging. Temperature Excursion Management in Pharmaceutical Storage is important during receipt of raw materials, manufacturing and distribution of ...
By AKCP
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How to Prepare Drug Microcapsules: A Holistic Approach
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 ...
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Cytochrome P450: A Vital Biosynthetic Enzymes for Drug Metabolism
Overview of Cytochrome P450 Cytochrome P450 (CYP450), is a family of hemoglobin-coupled monooxygenases. In mammals, CYP450 oxidizes steroids, fatty acids, and xenobiotics, playing an important role in the metabolism of various compounds as well as in the synthesis and breakdown of hormones. In plants, they regulate the synthesis of defense compounds, fatty acids, and hormones. With the progress ...
By BOC Sciences
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What is a surfactant?
Surfactants have become a flexible and diverse class of fine chemical products due to their physical and chemical effects such as wetting or anti-sticking, emulsification or demulsification, foaming or defoaming, solubilization, dispersion, washing, anti-corrosion, etc. Currently, surfactants are most widely used as detergents in daily life, but they have been found potentially useful in many ...
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Three generations of ADC: Nearly a decade of development-PII
Kadcyla and second-generation non-cleavable linkers Alternative linker design methodologies are still under development. Immunogen discovered a very powerful ADC by an accidental discovery. The lysine residue of trastuzumab is linked to DM1 via a non-cleavable linker containing N-succinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate (SMCC), an ADC (T-DM1, Kadcyla) authorized by the FDA in ...
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Liposomes in Anti-tumour Drug Carriers
Introduction Chemotherapy with anti-tumor agents is currently one of the most important systemic treatments for cancer. However, direct treatment with drugs lacks specificity and sensitivity and tends to attack normal cells indiscriminately, resulting in side effects. Liposomes, as drug carriers, provide a superior solution for maintaining or enhancing the efficacy of chemotherapy while reducing ...
By BOC Sciences
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Brief Introduction of ADC Drug Production Technology
Drug-to-antibody ratio (DAR, drug-to-antibody ratio) The number of cytotoxic drugs connected to each antibody is the drug-to-antibody ratio (DAR). When the DAR increases, the drug metabolism rate of ADC drugs increases, the half-life decreases, and the systemic toxicity increases. Ideally, when the DAR is 4, the drug has the highest efficacy. Therefore, in actual production, the drugs with DAR ...
By BOC Sciences
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Ultra Low Temperature (ULT) Pharmaceutical Freezers
What is an Ultra Low Temperature Freezer? An ultra-low temperature freezer (ULT freezer) typically has a temperature range of -45°C to -86°C and is used for the storage of drugs, enzymes, chemicals, bacteria and other samples. They are available in various designs and sizes depending on how much storage is needed. An upright ULT freezer gives easy access for frequent use and a chest ULT ...
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