Microbiological Assay of Two Selected Products of Ceftriaxone Powder for Injection from Pharmaceuticals' Market in Sudan

Background: Different techniques have classically been used to evaluate and assure the quality of medicines circulated on the market; one of the commonly uses is chemical analysis. However, some evidence has shown that there are other important indicators (e.g. bioequivalence, relative potency, etc.) that should also be considered when evaluating the quality of pharmaceutical products.Materials and Methods: A microbiological assay was conducted to compare the relative potency of two Ceftriaxone products (with a third one used as standard product) from the market using 3 reference bacteria including Streptococcus pneumoniae, Klebsiella pneumoniae and Staphylococcus aureus. Serial dilutions were made with the corresponding 1, 4, 8, 16 and 32-fold Minimum Inhibitory Concentration (MIC) of Ceftriaxone against the bacteria under investigation.Results: The relative potency of one product compared to the standard product was estimated to be within the acceptable range of bioequivalence (89.6%), while the other product showed unacceptable relative potency (72.3%).Conclusions: The microbiological assay is an effective and simple method for comparing the equivalency of injectable products. A complaint reporting system about quality and effectiveness problems needs to be considered as a priority source of such information to inform decision-makers.Keywords: Microbiological assay, Ceftriaxone, quality assurance, relative potency and genericmedicines

Interchangeability and Comparative Effectiveness between Micronized and Non-micronized Products of Glibenclamide Tablets

Background: During the last few years there was wide debate about the interchangeability and effectiveness between circulated products containing Glibenclamide in the market.Objectives: This study aimed to compare the effectiveness of this product “non-micronized” to the originator’s product of Glibenclamide tablets “of micronized” sulfonylurea.Methods: 12 volunteers received a dose of 5mg of Glibenclamide (from test and standard products) under fasting conditions in two separate sessions using randomized crossover design. Blood glucose level for the volunteers was monitored to avoid the development of hypoglycemia. Plasma samples were collected over 24 hours and analyzed using HPLC.Results: The maximum concentration Cmax for the test and reference products were 2.508 ± 0.104 and 3.526 ± 0.118 (ìg/ml) respectively and the area under the curve AUC0-[ were 3.511 ± 0.153 4.572 ± 0.202 (ìg.h/ml) for these products respectively, with a difference of about 24% between the test and reference products in its AUC.Conclusions: The results indicate that the test product is not bioequivalent to reference product. The difference in formulation between micronized product and non-micronized product of Glibenclamide tablets has impact on clinical outcomes.Key words:sulfonylurea,Blood glucose,hypoglycemia

The Palestinian health research system:who orchestrates the system, how and based on what? A qualitative assessment

Abstract Background In 2011, the WHO Eastern Mediterranean Region committee launched a strategy for scaling up research in the region to address the countries’ health needs through formulating and analysing the National Health Research System (HRS). Stewardship comprises three functions, namely governance, policy and priorities, and is a central pillar of this system to ensure a well-organised and functioning HRS. This study aims to examine the perceptions of the HRS performers to understand these functions and to generate insights for system strengthening. Methods The study was carried out in Palestine, targetting three sectors in the health field, including relevant governmental health institutions, schools of public health, and major local and international health agencies. The data were collected through 52 in-depth interviews (IDIs) and 6 focus group discussions (FGDs) with policy-makers, academics, directors, and experts. Participants and institutions were selected purposively based on a set of criteria and peer review. Results A total of 104 experts participated in the IDIs (52 participants) and FGDs (52 participants in 6 FGDs), highlighting that stewardship functions remain problematic and insufficiently performed, mainly due to a missing health research structural and regulatory framework and dispersed health research work. Despite the limited good practices, the majority of the participants described the Ethical Review and Clearance as weak due to the lack of an agreed-upon national committee and procedural quality and ethics guidelines for non-compliance. A policy or strategy dedicated to health research is lacking. The exercises of research priority-setting appear to be evolving despite the lack of consensus and the low levels of knowledge and experience in research prioritisation. Common gaps, such as weak political will and capacity support, the absence of a national unified regulating body, and the indirect effects of political conditions on strengthening the HRS as well as other sectors, also emerged. Conclusions The stewardship functions of the Palestinian HRS remain weak along with substantial political, structural, and resources and capacity gaps. The study emphasises the imperative need to initiate strategic efforts led by the MOH and the Palestinian National Institute of Public Health alongside with other players to strengthen a national HRS through improving the stewardship functions. To achieve this, attention and support of decision-makers, involvement, mobilisation and strategic dialogue are indispensable, in order to embark on building a well-regulated and coordinated structure, operational research policy, and prioritisation of essential research

Additional file 1: of The Palestinian health research system: who orchestrates the system, how and based on what? A qualitative assessment

Table S1. Responses on health research (HR) governance challenges and improvement opportunities. Table S2. Responses on HR related to coordination and cooperation status, gaps and improvements. Table S3. Responses on the status of HR ethical review and clearance. Table S4. Responses on the status of HR policy, gaps and improvements. Table S5. Responses on the pattern of HR priorities, gaps and improvements. Table S6. Comparison between HR priorities defined in this study and those defined by Palestinian National Institute of Public Health in August 2017. (DOCX 76 kb