METHODS: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials.
RESULTS: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing.
CONCLUSION: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies.
OBJECTIVE: To evaluate the surgical learning curve of a dual attending surgeon strategy in IS patients.
STUDY DESIGN: Retrospective study.
PATIENT SAMPLE: 415 IS patients (Cobb angle <90°) who underwent PSF using a dual attending surgeon strategy OUTCOME MEASURES: Primary outcomes included operative time, total blood loss, allogenic blood transfusion requirement, length of hospital stay and perioperative complication rate.
METHODS: Regression analysis using Locally Weighted Scatterplot Smoothing (LOWESS) method was applied to create the best-fit-curve between case number versus operative time and total blood loss in identifying cut-off points for the learning curve.
RESULTS: The mean Cobb angle was 60.8±10.8°. Mean operative time was 134.4±32.1 minutes and mean total blood loss was 886.0±450.6 mL. The mean length of hospital stay was 3.0±1.6 days. The learning curves of a dual attending surgeon strategy in this study were established at the 115th case (operative time) and 196th case (total blood loss) respectively (p
METHODS: Data of all patients diagnosed with NPC over a 5-year period from January 2015 to December 2019 inclusive were collected from the NPC registry of 3 main hospitals in Sabah. Age-standardized rates (ASRs) for different genders, ethnicities, and districts of origin were calculated.
RESULTS: 215 NPC patients were identified with a mean age at diagnosis of 49 (range 9-82). The ASR of NPC was 7.9/100,000 where the average age-adjusted male-to-female ratio was 2.4. The highest ASR was found in Dusun ethnicity in both male (3.19/100,000) and female (1.69/100,000) individuals, followed by Chinese (both genders), and Kadazan (for male individuals) and Bajau (for female individuals). The highest ASR was found in patients originating from Sandakan, Kota Kinabalu, Keningau, and Tawau.
CONCLUSION: This is the first report on the incidence of NPC in Sabah, Borneo. The data suggest high ASRs among the population, especially in male Dusun and Chinese ethnic groups. Further research looking into NPC in this state, especially on risk factors and ways to improve diagnosis and prevention among the population, is recommended.