RESUMO
Objectives@#The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. @*Methods@#The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. @*Results@#The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. @*Conclusion@#Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.
Assuntos
Estudos de Viabilidade , Equivalência Terapêutica , Medicamentos GenéricosRESUMO
Objective@#To evaluate the safety and efficacy of Blumea balsamifera (L.) DC for the treatment of urinary tract stones.@*Methods@#Data were collected from online databases, the Philippine National Library, and unpublished clinical trials. We obtained permission from authors of unpublished clinical trials but with existing patent applications. Studies were selected based on the criteria: randomized controlled trials (RCT) on the efficacy of Blumea balsamifera (L.) DC for the treatment of urinary tract stones given alone or in combination with a non-pharmacological/pharmacological intervention in comparison to a pharmacological/non-pharmacological intervention for urinary tract stones with participants aged 15 to 65 years in an ambulatory setting.@*Results@#Our search methods yielded a total of 20 studies. Four studies met our inclusion criteria. Patients who took sambong had a reduction in stone size by radiographic evidence 23.45 times more than those who took the placebo (p=0.001). Also, patients taking sambong were 38.04 times more likely to pass stones compared to those patients taking a placebo (p=0.0004). Patients taking sambong were 7.48 times more likely to have reduction or disappearance of signs and symptoms compared to the placebo group (p=0.008).@*Conclusions@#Sambong treatment is effective in treating patients with urolithiasis by radiographic evidence of a decrease in size and/or number of stones, the passage of stone/s and/or disappearance or reduction of signs and symptoms with no serious adverse events.