Stilescurtis1702

BACKGROUND Probiotics are pharmaceutical products that contain living bacteria and are used to manage certain disorders, as well as to enhance general health. There are some reports criticizing the quality of these products, highlighting findings such as pathogen contamination and misleading labeling. Regulation and control of probiotics vary between international regulatory authorities, creating a gap between probiotic manufacturers and regulatory bodies. METHODS In this article, the probiotics available in Saudi Arabia were analyzed in regard to their presented method of identification and labeling information. RESULTS Only 1 of 22 products had confirmed the bacterial strain using a genotypic method; the rest presented various phenotypic methods. More than half of the reviewed products did not contain the strain designation on the outside labeling of the probiotic. CONCLUSION The Saudi Food and Drug Authority should act by adopting a new guideline to control and regulate probiotics in Saudi Arabia, which could then be expanded to cover gulf countries (GCC).BACKGROUND More patients are now taking high-risk medicines such as non-vitamin K oral anticoagulants (NOACs). Hence, patient education materials need to be in an understandable format so that they can be empowered to act on their knowledge. Factors such as health literacy and the design of the medicine information material may influence the patient's ability to understand and act on key information. METHOD The PRISMA checklist was used to inform the study design. A structured search was conducted to obtain all freely accessible online educational resources designed for patients about the non-vitamin K antagonists (NOACs) during August 2018. Three search engines were used Google, Yahoo! and Bing, using the search terms "NOAC" and "anticoagulant" combined with "patient/consumer information and patient/consumer resources."We applied the Patient Education Materials Assessment Tool (PEMAT) to evaluate web-based patient education materials in terms of understandability and actionability for patients taking NOACs. RESULTS Of the 35 materials included, the majority of the materials (n = 32, 91%) were rated as highly understandable (PEMAT score ≥70%), and more than three-quarters of all the materials (n = 29, 83%) were rated as poorly actionable (PEMAT score less then 70%). Ravoxertinib manufacturer For understandability, the majority of materials neither provided a summary of the key points nor used visual aids for several items such as simple tables, illustrations, and photographs. For actionability, few materials provided a tangible tool, such as a checklist, to prompt the user into action (n = 4). Few used visual aids such as nonverbal cues to the written instructions (n = 4). CONCLUSION To improve the understandability and actionability of most of the NOAC patient education materials, there is a need to include more summaries of information, visual aids, and tangible tools such as checklists. Further research is warranted where patients are involved in providing feedback on the design of medicine information materials for NOACs.In the current pharmaceutical regulatory environment, patients continue to benefit from great advances in medical care. Sophisticated regulatory review systems have also evolved to ensure that safe and effective medicines are approved. However, these systems are not optimized in all countries. Gaps in individual regulatory agency capabilities together with duplication in non-value added national regulatory requirements, particularly in low- and middle-income countries (LMICs), can slow down regulatory approvals and therefore impede patient access to new medicines. These gaps exist despite the achievements in both regulatory convergence and harmonization of technical requirements by bodies such as the International Conference on Harmonization (ICH). There is a pressing need to strengthen regulatory review systems in emerging market economies as highlighted by the World Health Organization (WHO). These diverse challenges may seem overwhelming to individual national regulators, in part because of the sheer number of initiatives by multiple stakeholders, combined with a lack of information on concise practical actionable measures that can have a positive impact on review efficiency. This commentary presents 10 pillars that we believe represent the key hallmarks of strong regulatory review systems. Leveraging our internal company expertise at the global, regional, and country level across our entire product portfolio (both innovative and generic), we selected features proven to work in leading regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which are also relevant for other regulatory authorities, especially in LMICs.Phage display (PD) is a technology based on the presentation of functional exogenous peptides on the capsid surface of bacteriophages. PD is performed by introducing a DNA sequence of interest at a specific position within a functional viral gene. In addition, peptide phage libraries are powerful tools for expressing a wide range of random peptides and for specific peptide screening. Specifically, PD applications include the analysis of binding and interactions between proteins, the identification of bioactive peptides that bind to receptors, the identification of disease-associated antigens, and the identification of cell-specific peptides. Since its emergence, PD technology has revolutionized several fields in the biological sciences, such as oncology, cell biology, and pharmacology, the innumerable applications for which will be described throughout this review.BACKGROUND A fixed dose combination (FDC) product containing two components can be authorized for the use in 3 conceptual scenarios (1) as substitution for a treatment regimen containing both components given separately (substitution therapy) or (2) as replacement for a treatment regimen where the patient currently receives one of the components (add-on therapy) or (3) initial treatment of patients naïve to both components (initial combination therapy). METHOD Trends in European Medicine Agency (EMA) and Food and Drug Administration (FDA) approvals of FDC products for the 3 scenarios were explored by comparing the therapeutic indications retrieved from the EMA and FDA websites for FDCs approved between January 2000 and April 2017 within 5 selected therapeutic areas type 2 diabetes mellitus (T2DM), asthma, chronic obstructive pulmonary disease, hypertension, and human immunodeficiency virus (HIV) infection. RESULT Approval decisions between EMA and FDA were largely aligned for the substitution therapy and add-on therapy scenarios.