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PubMed Journals Articles About "Insights Planning Managing Drug Product Shortages" RSS

21:28 EST 28th February 2020 | BioPortfolio

Insights Planning Managing Drug Product Shortages PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Insights Planning Managing Drug Product Shortages articles that have been published worldwide.

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Showing "Insights planning managing drug product shortages" PubMed Articles 1–25 of 17,000+

Insights on planning for and managing drug product shortages.


Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products.

Pseudoephedrine (PSE) extracted from its dosage forms can be used as the starting material to prepare methamphetamine by drug abusers. Recently, some pseudoephedrine drug products marketed under the over the counter (OTC) monograph have been promoted as 'meth-deterrent'. The goal of this investigation was to evaluate the extraction and dissolution of these product against controls of non-meth-deterrent products of pseudoephedrine. Immediate release (IR) PSE OTC Product-C, Product-D and Product-E with meth-d...

How do drug shortages affect dermatologists?


New Report Examines Drug Shortages.

Use of a Predictive Regression Model for estimating Hold-Up Volume for Biologic Drug Product Presentations.

A drug delivery system is designed to administer a therapeutic dose according to its label claim. Upon delivery of a parenteral drug product, the volume remaining inside the container which cannot be extracted at the end of drug administration is called the hold-up volume (HUV) and is primarily considered product wastage. In order to meet the label claim every drug product container is filled with a slight excess volume to meet the label claim. For early stage products in clinical phase, where material avai...

Letter to the editor - Factual inaccuracies of the article Causes of drug shortages in the legal pharmaceutical framework.

Integrating drug- and formulation-related properties with gastrointestinal tract variability using a product-specific particle size approach: case example ibuprofen.

In the present study an in vitro-in vivo extrapolation of dissolution integrated to a physiologically-based pharmacokinetics modeling approach, considering a product-specific particle size distribution and a self-buffering effect of the drug, is introduced and appears to be a promising translational modeling strategy to support drug product development, manufacturing changes and setting clinically relevant specifications for immediate release formulations containing ibuprofen and other weak acids with simil...

Association between US Pharmacopeia (USP) monograph standards, generic entry and prescription drug costs.

Despite the importance of pharmacopeial standards, little is known regarding their effect on drug competition. Such information is of particular relevance given the rising costs of prescription drugs and the focus of policy-makers and other stakeholders on addressing these costs. We examined 982 prescription drugs approved by U.S Food and Drug Administration since 1982 to examine the association between U.S. Pharmacopeia (USP) standards, generic entry and prescription costs. The presence of a USP drug produ...

USP General Chapter <800> and Its Impact on Nursing Practice.

The Infusion Nurses Society (INS) and the Journal of Infusion Nursing (JIN) editors are pleased to debut Pharmacology Report, a recurring bimonthly column authored by Susan Kleppin, RPh, FASHP. Susan is an accomplished pharmacist in health-system pharmacy with significant experience in infusion therapy. Her column will discuss relevant pharmacology topics, including medications new to market, safe handling for hazardous drugs, and managing drug shortages. INS and JIN extend Susan a warm welcome.

Introduction: Novel insights into TB research and drug discovery.

Mycobacterium tuberculosis (Mtb), the causative agent of tuberculosis (TB), kills more people than any other bacterium. TB control is threatened by the continued spread of drug resistance; multi-drug and extensively drug resistant Mtb require longer, more costly, treatment with multiple drugs causing worse side effects and have a lower likelihood of treatment success. The urgent need for better treatment options for drug resistant Mtb has led the World Health Organization to prioritize development of not on...

Evaluation of Particle Techniques for the Characterization of Subvisible Particles from Elastomeric Closure Components.

Evaluating a particle profile for parenteral drug products is a well-known challenge due to inevitable variability of results with limited accuracy to actual particle levels present in the product, especially in the subvisible particulate (SbVP) range. It is important to understand the appropriate SbVP counting/characterization technology, methodology capability, and the particle source (intrinsic or extrinsic). Elastomeric closures are prevalent in many types of drug product container closure systems and a...

New regulatory strategies to manage medicines shortages in Europe.

Medicine shortages have been spreading in European countries. In many cases, the unavailability of medicinal products has a substantial impact on the capability of National healthcare systems in ensuring the continuity of care. Shortages originate from multifactorial causes. In particular, they can be due to supply-related factors (e.g., manufacturing issues, regulatory issues, logistics, distribution) and demand-related ones (e.g., fluctuating drug demand, parallel market, tendering, price and reimbursemen...

Army Antimalarial Drug Development: An Advanced Development Case Study for Tafenoquine.

Malaria is classified as a top-tier infectious disease threat associated with a high risk for mortality among U.S. service members deployed overseas. As malarial drug resistance degrades the efficacy of current gold standard drugs for malarial prophylaxis and treatment, it is vitally important to maintain a robust drug pipeline to discover and develop improved, next-generation antimalarial prevention and treatment tools. The U.S. Army Medical Materiel Development Activity (USAMMDA) manages the medical produ...

Key Insights on Participation Measurement from Real-world Health Care Interventions.

Overcoming Challenges of Implementing Closed System Transfer Device Clinical In-Use Compatibility Testing for Drug Development of Antibody Drug Conjugates.

Closed System Transfer Devices (CSTD) are a supplemental engineering control designed to reduce occupational exposure of hazardous drugs and are currently implemented in accordance to evolving regulations. Due to the novelty and complexity of these devices and their importance in clinical in-use testing, here we evaluated FDA approved CSTD, assessing product quality through stability indicating assays to determine any drug product incompatibilities. Six devices were used in a simulated compounding and admin...

Fibrin Degradation Product β15-42-New Insights in an Old Pathway.

Stakeholder perspectives on the challenges surrounding management and supply of essential medicines.

Background Shortages of essential medicines impact patient safety and raise the costs of medicines to consumers and governments. Ongoing medicine shortages have become a critical issue that threaten global access to medicines. Objective The aim of this study was to explore key stakeholders' perspectives on the challenges surrounding management and supply of essential medicines. Setting Western Pacific, Asia, Europe, North America, and Africa. Methods In-depth, semi-structured interviews with 47 participants...

The physical stability of drugs linked to quality-by-design (QbD) and in-process technology (PAT) perspectives.

The physical stability of solid-state forms in which drugs may exist is in some sense an overlooked aspect. In an era where strategies such as amorphous solid dispersions or co-amorphous preparations might provide answers to stumbling blocks such as poor drug solubility and bioavailability, the physical stability of such solid-state preparations should be a priority. Furthermore, the pharmaceutical industry is moving towards adapting a real time release of pharmaceutical products strategy, through the utili...

Synthesis and biological evaluation of cis-restrained carbocyclic combretastatin A-4 analogs: Influence of the ring size and saturation on cytotoxic properties.

Combretastatin A-4 (CA-4) is a highly cytotoxic natural product and several derivatives have been prepared which underwent clinical trial. These investigations revealed that the cis-stilbene moiety of the natural product is prone to undergo cis/trans isomerization under physiological conditions, reducing the overall activity of the drug candidates. Herein, we report the preparation of cis-restrained carbocyclic analogs of CA-4. The compounds, which differ by the size and hybridization of the carbocyclic rin...

Investigation of quality review issues and the association with application characteristics for new drug applications in first-cycle reviews.

Quality, essential in the drug development and approval process, was demonstrated to be a major reason leading to multiple reviews for New Drug Applications (NDAs) submitted to the United States Food and Drug Administration (USFDA). The present study aimed at systematically investigating quality deficiencies described in the first-cycle NDA reviews of the approved drug products to identify the types of concerns and the association between the occurrence of quality deficiencies and the characteristics of the...

Review of the most common chemometric techniques in illicit drug profiling.

The information generated through drug profiling can be used to infer a common source between one or several seizures as well as drug trafficking routes to provide insights into drug markets. Although well established, it is time-consuming and ineffective to compare all drug profiles manually. In recent years, there has been a push to automate processes to enable a more efficient comparison of illicit drug specimens. Various chemometric methods have been employed to compare and interpret forensic case data ...

Manipulation of pharmaceutical polymorphic transformation process using excipients.

In pharmaceutical field, it is vital to ensure a consistent product containing a single solid-state form of the active pharmaceutical ingredient (API) in the drug product. However, some APIs are suffering from the risk of transformation of their target forms during processing, formulation and storage.

Method to Predict Glass Vial Fogging in Lyophilized Drug Products.

Glass fogging is a phenomenon occurring in lyophilized drug products, and can be described as a thin product layer deposited on the inner surface of the glass container, in the area not covered by the lyo cake itself. It is often considered a cosmetic defect, however the loss of container closure integrity is a potential consequence of the fogging's expansion to the vial neck region, making this a potential critical defect. Thus, a method for predicting the extent of vial fogging before the actual freeze dr...

An update on pediatric surgical epilepsy: Part I.

Epilepsy affects many children worldwide, with drug-resistant epilepsy affecting 20-40% of all children with epilepsy. This carries a significant burden for patients and their families and is strongly correlated with poor cognitive outcomes, depression, anxiety, developmental delay, and impaired activities of daily living. For this reason, we sought to explore the role of pediatric epilepsy surgery and provide an overview of the factors contributing to epilepsy surgery planning and execution. We review the ...

Dearomative Photocatalytic Construction of Bridged 1,3-Diazepanes.

The construction of diverse sp 3 -rich skeletal ring systems is of importance to drug discovery programmes and natural product synthesis. Herein, we report the photocatalytic construction of 2,7-diazabicyclo[3.2.1]octanes (bridged 1,3-diazepanes) via a reductive diversion of the Minisci reaction. The fused tricyclic product is proposed to form via radical addition to the C4 position of 4-substituted quinoline substrates, with subsequent Hantzsch ester-promoted reduction to a dihydropyridine intermediate whi...


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