Journal of Preventive Medicine

Description

Over the past ten years, the regulatory science for generic Dry Powder Inhalers (DPIs) in the United States (U.S.) has developed. The draft Product-Specific Guidance (PSG) for salmeterol xinafoate inhalation powder and fluticasone propionate was made public by the FDA in 2013. The details of a weight-of-evidence method for establishing Bioequivalence (BE) were provided in this, the first PSG for a DPI that was available in the United States. These recommendations were supported by a variety of research activities, including in vivo and in vitro studies. In January 2019, the first generic DPI for salmeterol xinafoate inhalation powder and fluticasone propionate was approved in the United States. This review discusses research using novel in vitro and in silico methods that may potentially facilitate generic DPI development and approval, as well as the scientific and regulatory activities. Over the past decade, regulatory science for generic dry powder inhalation products around the world has changed. The FDA published a summary of product considerations and potential Critical Quality Attributes (CQAs) in the revised draft guidance for Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI).0020The International Conference for Harmonization of (ICH) Guidelines' aspects of pharmaceutical development and quality by design (QbD) principles must be implemented, as emphasized in this guidance. This review outlines the scientific and regulatory obstacles that must be overcome in order to successfully introduce a generic DPI to the market. Prior to the first approval of a generic DPI product in the United States, guidance recommendations were supported by quality research studies. This review's objective is to focus on pertinent issues and challenges related to the CMC topics of the generic DPI quality attributes. Additionally, this review offers suggestions for expediting generic approvals to applicants for Abbreviated New Drug Applications (ANDAs). As the first line of defense against the negative health effects that are associated with ticks, personal protection measures to prevent human tick encounters that result in bites are widely recommended.

Protective Effect

This includes using repellents, wearing protective clothing that has been permethrin-treated or not, and checking for ticks after coming inside. You can do this by taking a shower or bath (to help find ticks on the skin) and taking off your outdoor clothing and running it through a dryer on high heat to kill ticks that haven't been found. These measures are cost-effective, but they must be utilized consistently for maximum effectiveness. In this paper, I examine the effectiveness of the aforementioned personal protection measures in preventing tick bites and tick-borne diseases, as well as the level of use (acceptability combined with behavior). Variable phrasings of survey questions pertaining to a specific personal protection measure have been used in studies on the level of use of personal protection measures to prevent tick bites. Additionally, results have been presented based on varying frequencies of taking action. This makes it harder to sum up the results, but the studies all show that people frequently take steps to prevent tick bites, most commonly by wearing untreated protective clothing or conducting tick checks (done routinely by 30 to 70% of respondents in most studies of the public), then by showering or bathing after being outside or using repellents on clothing or skin (15 to 40% range), with permethrin-treated clothing being the least frequently used method (5 to 20% range). A number of experimental studies have demonstrated that coveralls and uniform-style clothing treated with repellents or permethrin can reduce the number of tick bites, but no such studies have been conducted on people who wear summer-weight clothing on a daily basis. In addition, a number of cross-sectional and case-control studies have investigated the connections between the application of various personal protection measures and the development of Lyme disease or other infections transmitted by ticks. For each personal protection measure, the results are mixed, with some studies finding a reduction in tick-borne disease with regular use, while others found no similar protective effect. Although the information gathered up to this point has not been sufficiently detailed to clarify the circumstances under which protection is achieved, particularly with regard to frequency of use, parts of the body that are protected, and the utilization of combinations of two or more potentially protective measures, one possible interpretation is that these personal protection measures can protect against infection carried by ticks. In conclusion, the public uses personal protection measures to avoid tick bites. More research is needed to better understand how these measures should be used to have the greatest impact on public health. Utilizing quarterly Medicaid data for the years 2011–2018 and a difference-in-differences method that compares the evolution of prices of allegedly collusive drugs with a group of competitive control drugs, we investigate cartels in the US generic drug industry.

Healthcare Services

When collusion is widespread, establishing a suitable control group is challenging, market structure shifts must be taken into account when defining the control period, and drug-to-drug heterogeneity exists, according to our research. We concentrate on six drug markets that were a part of the expanded initial complaint and where there was no entry in the same class during the collusive period. This makes it possible to accurately measure the impact of collusion on prices. Inertia refers to consumers' propensity to repurchase products. The slow and limited adoption of generic medications despite their lower prices is the focus of this study, which examines inertia in the choice between brand-name and generic medications. We focus on Pitavastatin, a widely prescribed lipid-lowering medication, using claims data from Japan. We have the unique opportunity to determine the impact of inertia by keeping track of the time before and after the generic entry. In order to quantify the magnitude of each component, we develop a choice model that incorporates price, diverse brand preferences, and inertia. Both inertia and heterogeneity in brand preferences have significant effects, according to our findings. Counterfactual simulations suggest that a nudge policy that encourages patients to switch from brand-name medications to cheaper generics, for example, could have significant effects and help patients make the best choices. For developing nations like India to improve their quality of life, it is essential to establish standard, universal, and high-quality healthcare services. In India, a number of healthcare programs, including the Jan Aushadhi Scheme and the Mukhyamantri Nishulk Dava Yojna, offer free medical care and the distribution of medicines. The supply chain for the majority of the medicines provided by these programs has already been established. In addition to having distinct self-lives, costs, and logistics requirements, the variety of generic drugs varies in quantity across various storage and consumption locations. It was discovered that these supply chains need to perform better in a number of different ways. As a result, the distribution of generic drugs in Rajasthan is the subject of the current investigation. The study takes into account a process view of the existing supply chain, sourcing, ordering, and procurement, logistics and warehousing, inventory management, and information system, among other aspects of generic drug distribution. In order to come up with a plan for better resource utilization, various methods like value stream mapping, an integrated analytical tool for ordering, the 5S practice, and a performance measurement system are looked into.