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Drug Enforcement Administration Articles & Analysis
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Joint replacement surgery—most commonly performed on hips and knees—has transformed the lives of millions by relieving pain, restoring movement, and improving quality of life. As technology advances, surgeons now have choices in how they fixate the prosthesis to the bone. The two primary techniques are cemented fixation and cementless fixation (also called uncemented fixation). ...
Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring. Here’s an overview of CAPA requirements in ISO 13485 for medical device ...
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 ...
Introduction The pharmaceutical industry faces stringent regulatory requirements to ensure the safety, efficacy, and quality of drug products. Among these, Current Good Manufacturing Practice (CGMP) guidelines set by agencies such as the U.S. Food and Drug Administration (FDA) play a pivotal role. Pharmaceutical CGMP manufacturing encompasses all processes that abide by these guidelines to ensure ...
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 ...
Vaccines are considered one of the most successful medical interventions in the past few centuries, aiming to harness the human immune system and generate lasting protection against specific diseases. Traditional vaccines rely on the use of inactivated pathogens to trigger an immune response. However, many of these formulations carry a high risk of causing allergies or autoimmune reactions. ...
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 ...