Topics

PubMed Journals Articles About "Completes Expansion Specialty Drug Product Capabilities" RSS

16:11 EST 25th January 2020 | BioPortfolio

Completes Expansion Specialty Drug Product Capabilities PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Completes Expansion Specialty Drug Product Capabilities articles that have been published worldwide.

More Information about "Completes Expansion Specialty Drug Product Capabilities" on BioPortfolio

We have published hundreds of Completes Expansion Specialty Drug Product Capabilities news stories on BioPortfolio along with dozens of Completes Expansion Specialty Drug Product Capabilities Clinical Trials and PubMed Articles about Completes Expansion Specialty Drug Product Capabilities for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Completes Expansion Specialty Drug Product Capabilities Companies in our database. You can also find out about relevant Completes Expansion Specialty Drug Product Capabilities Drugs and Medications on this site too.

Showing "Completes Expansion Specialty Drug Product Capabilities" PubMed Articles 1–25 of 14,000+

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...


Little Consistency In Evidence Cited By Commercial Plans For Specialty Drug Coverage.

We found wide variation in the evidence that US commercial health plans reported reviewing in their specialty drug coverage policies. There was little consistency in the numbers or types of studies cited by health plans. On average, only 15 percent of health plans' coverage policies cited the same study evaluating a specific drug for a specific indication.

How does open innovation lead competitive advantage? A dynamic capability view perspective.

The relationship between open innovation and company's competitive advantage, and organisational capabilities required remains to be explained. This study was conducted to answer the following questions. Does open innovation create organisation's competitive advantage? What types of capabilities are needed in the process of open innovation reaching competitive advantage, and what kind of relationship do they have? This study extends the scope of theoretical discussion about open innovation from the point of...


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...

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...

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...

Successful expansion of community-based drug-resistant TB care in rural Eswatini - a retrospective cohort study.

Provision of drug-resistant tuberculosis (DR-TB) treatment is scarce in resource-limited settings. We assessed the feasibility of ambulatory DR-TB care for treatment expansion in rural Eswatini.

Impact of a co-pay accumulator adjustment program on specialty drug adherence.

To assess the impact of a co-pay accumulator adjustment program (CAAP) on usage patterns of autoimmune specialty drugs, comparing health savings account (HSA) or preferred provider organization (PPO) plan enrollees before and after implementation of the CAAP.

Black-White differences in barriers to specialty alcohol and drug treatment: findings from a qualitative study.

The objective of this study was to explore, in-depth, differences in barriers to specialty alcohol and drug treatment services between Black and White participants with recent substance use disorders (SUD). We recruited 34 participants with a recent SUD of White and Black racial/ethnic descent for qualitative interviews. Interviews were coded to identify barriers to specialty treatment. We found that barriers related to stigma and lack of social support were more pervasive in the narratives of Blacks as com...

Are You Applying to More Than One Specialty?

Although the majority of U.S. medical students predominantly apply to only one specialty, some apply to more than one. When it comes to emergency medicine (EM), applicants may apply to additional specialties due to several reasons: being international medical graduates as well as their inability to make a decision regarding the choice of specialty, fear from the growing competitiveness of EM, or the desire to stay in a specific geographic area. Accordingly, in this article we aim to guide medical students t...

Tools to improve referrals from primary care to specialty care.

Referrals from primary to specialty care are a critical first step in coordination of specialty care, but shortcomings in the appropriateness, clarity, or completeness of referrals are common. We examined (1) whether 3 tools to coordinate specialty care are associated with better referral characteristics and (2) whether greater perceived helpfulness of these tools is associated with better referral characteristics among specialists who use all 3 of them.

Access to Elective Orthopaedic Surgery After the Affordable Care Act Medicaid Expansion: The New York State Experience.

As part of the Patient Protection and Affordable Care Act, states were given the option of expanding Medicaid coverage to include adults younger than age 65 years with income at or below 138% of the federal poverty level. Although this expansion was intended to provide health care coverage to an estimated 20 million Americans, several studies have shown increased coverage does not equate to increased access to care by specialty providers.

2D Mechanical Metamaterials with Widely Tunable Unusual Modes of Thermal Expansion.

Most natural materials expand uniformly in all directions upon heating. Artificial, engineered systems offer opportunities to tune thermal expansion properties in interesting ways. Previous reports exploit diverse design principles and fabrication techniques to achieve a negative or ultralow coefficient of thermal expansion, but very few demonstrate tunability over different behaviors. This work presents a collection of 2D material structures that exploit bimaterial serpentine lattices with micrometer featu...

The Effect of Reduced Drug Copayments on Adherence to Oral Diabetes Medications Among Childless Adults in Wisconsin Medicaid.

Medication adherence is an indicator of the quality of drug use, which is associated with better health outcomes and reduced health care expenditures. Drug cost sharing can be a barrier to adherence, especially for low-income individuals with chronic conditions. Most of the existing studies in a Medicaid population have evaluated the effects of increasing drug copayments, but few studies have evaluated the effects of reducing drug copayments on medication adherence. Medicaid coverage for low-income childles...

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...

Listening for the therapeutic window: Advances in drug delivery utilizing photoacoustic imaging.

The preclinical landscape of photoacoustic imaging has experienced tremendous growth in the past decade. This non-invasive imaging modality augments the spatiotemporal capabilities of ultrasound with optical contrast. While it has principally been investigated for diagnostic applications, many recent reports have described theranostic delivery systems and drug monitoring strategies using photoacoustics. Here, we provide an overview of the of the progress to date while highlighting work in three specific are...

Microfluidics for personalized drug screening of cancer.

Resistance to targeted therapies is a major clinical challenge in cancer treatment. Despite technological advances, robust biomarkers or platforms predictive of treatment response are lacking owing to the inherent nature of complex genomic landscape of carcinoma. Nevertheless, recent efforts centred on performing direct drug screening on patient-derived cells through their ex vivo expansion and maintenance have enabled personalized stratification of treatment modalities. Microfluidics is one such technology...

Navigating the Wild West of Medication Adherence Reporting in Specialty Pharmacy.

Estimating medication adherence through the use of pharmacy claims-based adherence calculations such as medication possession ratio (MPR) and proportion of days covered (PDC) plays a significant role in specialty pharmacy practice. Although MPR and PDC are frequently used in clinical practice, calculation methodologies vary, making meaningful comparisons of adherence rates difficult. In addition, MPR and PDC are increasingly used by insurance companies, pharmacies, accrediting bodies, and drug manufacturers...

The Impact of HIV-1 Drug Escape on the Global Treatment Landscape.

The rising prevalence of HIV drug resistance (HIVDR) could threaten gains made in combating the HIV epidemic and compromise the 90-90-90 target proposed by United Nations Programme on HIV/AIDS (UNAIDS) to have achieved virological suppression in 90% of all persons receiving antiretroviral therapy (ART) by the year 2020. HIVDR has implications for the persistence of HIV, the selection of current and future ART drug regimens, and strategies of vaccine and cure development. Focusing on drug classes that are in...

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...

Need for sustainable approaches in antileishmanial drug discovery.

Leishmaniasis is a neglected parasitic disease for which the current antileishmania therapeutics are hampered by drug toxicity, high cost, need for parenteral administration, increasing treatment failure rates, and emergence of drug resistance. The R&D pipeline had run fairly dry for several years, but fortunately some new drug candidates are now under (pre)clinical development. Identification of novel drugs will nevertheless remain essential to adequately sustain and improve effective disease control in th...

Pharmacovigilance in ophthalmology in Switzerland: an analysis of the most frequently reported ocular adverse drug reactions within the last 25 years.

Although systemic drugs can exert local effects on the eye, ophthalmology is a medical specialty with perhaps the fewest assessed adverse drug reactions (ADRs), representing a particular challenge in pharmacovigilance. Our aim was to quantify ADRs in ophthalmology in Switzerland, with a focus on angiogenesis inhibitors.


Quick Search