Drug Enforcement Administration Articles & Analysis
87 articles found
Liposomes, spherical vesicles composed of one or more phospholipid bilayers, have garnered significant attention in the field of drug delivery due to their unique properties. These nanocarriers offer a promising approach to overcome challenges associated with traditional drug administration, enhancing therapeutic efficacy while minimizing side effects. This article will delve into the role of ...
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 ...
HCP (Host Cell Proteins) residual detection is a key quality control step in the field of biopharmaceuticals, aiming at ensuring that the proteins of the host cells used for producing therapeutic proteins in any cell-based production system are maintained at acceptable low levels in the final drug product.ImportanceHCPs are impurities during the production process, which may adversely affect the ...
One of the biggest challenges clinical data management faces is the sheer amount of data that needs to be processed. With more and more patient data becoming available, it can be difficult for CDM systems to keep up. In addition, many CDM systems are not user-friendly or interactive, making it difficult for users to get the most out of them. What challenges do clinical data management systems ...
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Successful AAV formulation demands understanding factors such as administration routes and organ-specific distribution, stability, vector aggregation, manufacturing-related impurities, and vector-host interactions. Enhancing cGMP Capacity: A Prerequisite for Efficient Therapies To accompany this technical transformation, expansion in cGMP capacity is a necessity. cGMP represents ...
Poly(lactic-co-glycolic acid) (PLGA) is a functional polymer organic compound randomly polymerized by lactic acid (PLA) and glycolic acid (PGA). It has been approved by the U.S. Food and Drug Administration It is certified by the Food and Drug Administration (FDA) and is a copolymer material available on the market. PLGA has good biocompatibility, biodegradability, mechanical strength, good ...
Nanogels (NGs), namely nanoscale hydrogel particles, are three-dimensional network systems formed by physical or chemical cross-linking of polymers. Nanogels have received widespread attention in recent years due to their unique properties and potential applications in various fields such as drug delivery, tissue engineering, and diagnostics.Classification of NanogelsAccording to the phase change ...
In recent years, various nucleic acid-based therapies (NBT) have emerged as effective and specific activators of endogenous gene expression. Unlike gene therapy approaches supplementing gene expression, RNA-targeted therapy enhances protein production by selectively modulating cellular mechanisms mediated by endogenous RNA, such as transcription, splicing, translation, mRNA stability, and ...
Transdermal drug delivery system is a type of drug formulation that is absorbed into the body circulation through capillaries at a certain rate through the skin to produce drug effects. Transdermal drug delivery systems allow the drug to continuously diffuse through the skin, penetrate and absorb into the blood circulation, maintain stable blood concentrations for a long time, reduce the ...
The COVID-19 pandemic has killed millions of people. Vaccines certainly are the most outstanding ways to prevent major diseases and death, though they haven't eliminated infections. At present, the most effective vaccine is the mRNA vaccine developed by Pfizer-BioNTech and Moderna. Before that, mRNA technology stopped in the lab phase. How to apply mRNA technology to more complex diseases in the ...
In the field of medicine, effectively delivering drugs to the target site in the body is crucial for successful treatment. Over the years, several innovative drug delivery systems have been developed to improve drug efficacy and patient outcomes. In this article, we will discuss four novel drug delivery systems that have shown promising results in recent research. These systems include ...
Medical devices are incredibly important in today’s world. They play a significant role in the treatment and prevention of various medical conditions. However, their effectiveness can be compromised if they are not packaged correctly. Packaging is an essential component of maintaining the integrity and shelf life of medical devices, especially during transportation and storage. Read on ...
Regulatory Requirements and Standards The Federal Drug Administration (FDA) oversees medical device package testing in the United States. ...
Microneedle patch technologies have revolutionized the field of drug delivery, offering a wide range of advantages over traditional methods. These innovative patches provide a minimally invasive and painless alternative to injections while ensuring precise and controlled drug administration. In this article, we will explore various types of microneedle patch technologies, including ...
Transdermal drug delivery systems have gained considerable importance in the pharmaceutical industry due to their convenience, effectiveness, and ease of use. These systems rely on various excipients, which are inactive substances that aid in the delivery and absorption of active drug compounds through the skin. In this article, we will discuss eight important excipients commonly used in ...
Patient-centric drug development is a divisive concept. Dismissed as a buzzword by some. Adopted extensively by others. It has, nevertheless, gained enormous traction over the last decade. This new approach to treatment incorporates patient perspectives into drug development. A key benefit is the keener focus on convenience and safe drug administration. Traditional approaches, prioritising ...
Bleeding disorders, a collection of conditions that prevent blood from clotting correctly, can be life-threatening. They’re caused by issues such as aberrant platelets, abnormal clotting proteins, or problematic blood vessels. Understanding how blood clots normally can help elucidate why these disorders are so serious. In a standard clotting process, platelets, a type of blood cell, act ...
Opioid-related addiction, overdose and death is a widespread public health crisis. A recent paper published in The Journal of Pharmacology and Experimental Therapeutics by Dr. Renata Marchette working within the National Institute on Drug Abuse Intramural Research Program provides a model example of the how plethysmography can be used to assess ventilatory behavior changes that occur with opioid ...
Host Cell Residual DNA (rcDNA) refers to fragments of DNA derived from host cells that may be present in biological products. These products must not contain foreign substances, particularly host DNA, to avoid immune rejection and potential threats to life safety. Regulatory agencies worldwide have imposed strict limits on the amount of rcDNA, and various pharmacopoeias have outlined several ...
Structural biology is an important field in drug discovery as it helps researchers understand the three-dimensional structure of proteins and how they interact with other molecules. This knowledge is crucial in developing new drugs as it allows scientists to target specific proteins and understand how they contribute to diseases. One of the most important resources in structural biology is the ...