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103 articles found
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 ...
Absorption refers to how a drug is absorbed into the bloodstream after administration. Factors influencing this process include the drug’s solubility, chemical stability, and the route of administration. ...
When studied in living organisms, this relationship is referred to as in vivo PK/PD, a discipline that provides invaluable insights into drug behavior within a biological context. Pharmacokinetics: The Journey of a Drug The pharmacokinetic profile of a drug describes its absorption, distribution, metabolism, and excretion (ADME) processes. ...
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 ...
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 ...
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. An effective PK study offers invaluable insights into the required timing, dosage, route of administration, and potential drug interaction. Thus, ...
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 ...
In such a scenario, if a patient does not react to a drug, it may be decided to change the drug or dosage. Some therapeutic areas and scenarios like immuno-oncology, multi-arm trials also add new levels of complexity to clinical trials. ...
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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 ...
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. ...
Ordinary nanogels will swell when absorbing water, and their drug administration and subsequent release behavior will be single. Environmentally responsive nanogels will swell or dissolve when exposed to different environments, and their administration and subsequent release behavior will be more intelligent. ...
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 subcellular localization.Currently, the US Food and Drug Administration (FDA) and the European Medicines Agency ...
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 ...
Based on the needs above, current ionizable cationic lipids approved by Food and Drug Administration, such as DLinMC3-DMA (MC3), ALC-0315, and SM-102, do not meet the requirement of "biodegradable". ...
FDA Requirements The U.S. Food and Drug Administration (FDA) oversees the manufacturing of sterilized medical devices and their packaging. ...
The most reliable way to detect HP is to use this non-invasive 13C-UBT method, which can infer H. pylori in the stomach by detecting the 13C/12C isotope ratio in the exhaled gas after oral administration of 13C-urea. Drug Metabolism Study The study of drug metabolism in the body is a very critical process for the development of new ...
Over the years, several innovative drug delivery systems have been developed to improve drug efficacy and patient outcomes. ...
Factors Considered When Determining Shelf Life Expiration Dates Shelf life expiration dates are vitally important to ensure medical devices are safe to use. The Food and Drug Administration (FDA) requires product labels to indicate an expiration date if a certain component is not useful past a certain date. ...