Search results for "Drug product"
showing 8 items of 8 documents
Do terrorism, organized crime (drug production), and state weakness affect contemporary armed conflicts? An empirical analysis
2015
ABSTRACTIn 2014, the UN Security Council emphasized the dangers of terrorism, criminal activity (especially drug production and trafficking), and state weakness in conflict areas. However, neither policy debates nor scholarly analyses have focussed on the potential impact of these elements on conflict dynamics and characteristics, and the investigated partial relationships have led to inconclusive results. This article explores the presence in armed conflicts of terrorist groups among fighting parties, major drug production (indicating the presence of activities typical of criminal organizations), and state failure in the period 1990–2011. Focussing on intrastate conflicts, this article hig…
Impact of orphan drugs on Latvian budget
2016
Background Number of orphan medicinal products on the market and number of rare disease patients, taking these usually expensive products, are increasing. As a result, budget impact of orphan drugs is growing. This factor, along with the cost-effectiveness of orphan drugs, is often considered in the reimbursement decisions, directly affecting accessibility of rare disease therapies. The current study aims to assess the budget impact of orphan drugs in Latvia. Methods Our study covered a 5-year period, from 2010 to 2014. Impact of orphan drugs on Latvian budget was estimated from the National Health Service’s perspective. It was calculated in absolute values and relative to total pharmaceuti…
Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms
2014
Excipients encompass a wide range of properties that are of importance for the resulting drug product. Regulatory guidelines on biowaivers for immediate release formulations require an in depth understanding of the biopharmaceutic effects of excipients in order to establish bioequivalence between two different products carrying the same API based on dissolution tests alone. This paper describes a new approach in evaluating biopharmaceutic excipient effects. Actually used quantities of a model excipient, lactose, formulated in combination with APIs from different BCS classes were evaluated. The results suggest that companies use different (relative) amounts depending on the characteristics o…
Adjuncts for ovarian stimulation: when do we adopt “orphan indications” for approved drugs?
2009
Several drugs, shown to be safe for other uses, have proven to be highly effective adjuncts for ovarian stimulation. The authors evaluate these "orphan" indications and make recommendations so that more patients will benefit from their use.
Unraveling the behavior of oral drug products inside the human gastrointestinal tract using the aspiration technique: History, methodology and applic…
2020
Fluid sampling from the gastrointestinal (GI) tract has been applied as a valuable tool to gain more insight into the fluids present in the human GI tract and to explore the dynamic interplay of drug release, dissolution, precipitation and absorption after drug product administration to healthy subjects. In the last twenty years, collaborative initiatives have led to a plethora of clinical aspiration studies that aimed to unravel the luminal drug behavior of an orally administered drug product. The obtained drug concentration-time profiles from different segments in the GI tract were a valuable source of information to optimize and/or validate predictive in vitro and in silico tools, freque…
In vivopredictive release methods for medicated chewing gums
2012
Understanding the performance of a drug product in vivo plays a key role in the development of meaningful in vitro drug release methodology. In case of functional chewing gums, the mode and the mechanism of release and the site of application differ significantly from other conventional solid oral dosage forms and require a special consideration to extract meaningful information from clinical studies. In the current study, suitable drug release methodology was developed to predict the in vivo performance of an investigated chewing gum product. Different parameters of the drug release testing apparatus described in the Ph. Eur. and Pharmeuropa were evaluated. Drug release data indicate that …
Equivalence Testing With Particle Size Distribution Data: Methods and Applications in the Development of Inhalative Drugs
2017
ABSTRACTKey criteria of the quality of inhalative drugs are assessed in experiments generating so-called particle size distributions as data. Many experiments of that kind are carried out to demonstrate that necessary modifications to whatever part of the manufacturing process do not substantially change basic characteristics of an inhalable drug product. The equivalence testing procedures we derive for that purpose rely on different models accommodating the specific structure of such data and on different ways of specifying the region of nonrelevant differences. For each hypotheses formulation, three different tests are derived (two parametric and one asymptotically distribution-free proce…
Rare diseases and orphan drugs: Latvian story
2014
Background Ten years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Orphan diseases have been recognized as a priority area for action in the public health system, though there are significant differences in the national healthcare services for rare diseases among the EU States. This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries. Methods We used the national plan for rare diseases, EUCERD reports, Orphanet data, Latvian and European regulations, publicly availa…