Displaying publications 1 - 20 of 2412 in total

Abstract:
Sort:
  1. Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
    Boobalan J, Sohn KB, Shinawatra O
    Ther Innov Regul Sci, 2024 Mar;58(2):223-233.
    PMID: 38194164 DOI: 10.1007/s43441-023-00600-7
    When the regulatory requirements are converged or harmonized, the country-specific variance of countries is often reduced or omitted, and this facilitates the possibility of preparing a core dossier that caters to multiple countries. When such options of a core dossier are acceptable to multiple countries, the resource required to prepare the dossier and the time taken to prepare it is also reduced, thus eliminating resource constraints in supporting dossier planning and preparation and indirectly facilitating earlier submission in countries. In this paper, the authors have illustrated a process applied to standardize the dossier requirements amongst selected countries in Asia, producing an output of a core dossier that applies to four submission types amongst these countries. The core dossier adopts the International Council for Harmonization-Common Technical Dossier format as a reference. Main focus is the standardization of format and requirements within the Module 3 or Chemistry Manufacturing Controls sections of the dossier, which from the authors' organizational experience usually notes a higher variances and country-specific elements. Development of the dossier standardization process is due to an internal hurdle within the authors' organization, where global resource constraints and prioritizations of dossier preparation and compliance review process needed to be improved to facilitate earlier or near-simultaneously submissions in the majority of the Asia countries. The paper demonstrates an assessment of the dossier components and standardization to assemble a fit-for-purpose core dossier termed 'Asia Core Dossier' (ACD). ACD has been successfully implemented within the authors' organization to reduce country-specific requirements and facilitate earlier (fit for strategy) submissions in the selected Asia countries. The paper also discusses the tangible benefits of the authors' experiences from utilizing the ACD. Regulatory professionals in different organizations could reference the ACD as a template for preparing a simplified and efficient dossier and as a relevant component of Good Submission Practice (GSubP).
    Matched MeSH terms: Asia
  2. Abstracts of the 13th Asia-Pacific International Academy of Pathology Congress 2023 held 16th to 18th June 2023
    Malays J Pathol, 2023 Aug;45(2):299-313.
    PMID: 37658541
    No abstract available.
    Matched MeSH terms: Asia
  3. The establishment of the Asia-Pacific Oral Cancer Network-Inaugural stakeholders' Meeting
    Syed Mohd Sobri SNS, Kanapathy J, Liew CS, Cheong SC
    Oral Dis, 2020 Jul;26(5):1094-1097.
    PMID: 32145142 DOI: 10.1111/odi.13320
    The majority of oral cancer cases occur in Asia and the incidence is expected to continue to rise. Oral cancer is amenable to early detection through visual oral examination yet in many Asian countries, the disease presents at a late stage. The barriers to early detection are similar across the Asia-Pacific countries therefore, strategies to address these could be more effective if there were concerted efforts and joint resources amongst the countries. To facilitate better engagement and collaboration between stakeholders in oral cancer detection and management, the Asia-Pacific Oral Cancer Network (APOCNET) was established and the inaugural meeting was held in Kuala Lumpur on the 13th to 15th of September 2019. In this meeting, we identified the challenges faced in the early detection and management of oral cancer amongst the stakeholder countries, showcased the successful oral cancer programs in the region and identified strategic areas for collaboration. For this, notable international speakers and those from local universities and the Ministry of Health Malaysia were invited to share their experiences. The lessons learned from our neighbouring countries could lead to the implementation of similar programs that could help reduce the oral cancer burden in the region.
    Matched MeSH terms: Asia/epidemiology
  4. Unmet needs and practical solutions in the management of invasive mould infections in Asia
    Chen YC, Chayakulkeeree M, Chakrabarti A, Gan GG, Kwong YL, Liu WL, et al.
    J Antimicrob Chemother, 2022 09 30;77(10):2579-2585.
    PMID: 35904002 DOI: 10.1093/jac/dkac251
    Management of invasive mould infections (IMIs) is challenging in Asia, as awareness among medical practitioners can be low and resources are limited. Timely diagnosis and appropriate treatment of IMIs can mitigate the impact on morbidity and mortality, but diagnostic methods, as well as access to preferred antifungal medications, may vary throughout the region. Knowledge of local epidemiology and accurate diagnosis and identification of causal pathogens would facilitate optimal treatment but data in Asia are lacking. To address these unmet needs in the management of IMIs, this paper is a call for urgent action in the following areas: improving awareness of the threat of IMIs; providing education to frontline clinicians across a broad range of specialties on 'red flags' for suspicion of IMIs; prioritizing cost-effective rapid diagnostic testing; improving access to preferred antifungal medications; and closing the gaps in local epidemiological data on IMIs to inform local treatment guidelines.
    Matched MeSH terms: Asia/epidemiology
  5. Fulltext Asian Best Practices for Care of Diabetes in Elderly (ABCDE)
    Kalra S, Dhar M, Afsana F, Aggarwal P, Aye TT, Bantwal G, et al.
    Rev Diabet Stud, 2022 Jun 30;18(2):100-134.
    PMID: 35831938 DOI: 10.1900/RDS.2022.18.100
    The elderly population with diabetes is diverse with the majority experiencing a decline in physical and mental capabilities, impacting the entire diabetes management process. Therefore, a need for geriatric-specific guidelines, especially for the Asian population, was identified and subsequently developed by an expert panel across government and private institutions from several Asian countries. The panel considered clinical evidence (landmark trials, position papers, expert opinions), recommendations from several important societies along with their decades of clinical experience and expertise, while meticulously devising thorough geriatric-specific tailored management strategies. The creation of the ABCDE best practices document underscores and explores the gaps and challenges and determines optimal methods for diabetes management of the elderly population in the Asian region.
    Matched MeSH terms: Asia/epidemiology
  6. Fulltext Expert consensus on the management of chronic lymphocytic leukaemia in Asia
    Tse E, Kwong YL, Goh YT, Bee PC, Ng SC, Tan D, et al.
    Clin Exp Med, 2023 Oct;23(6):2895-2907.
    PMID: 36795237 DOI: 10.1007/s10238-023-01007-2
    In recent years, considerable progress has been made in the standard treatment for chronic lymphocytic leukaemia (CLL) due to the availability of new potent drugs. However, the majority of data on CLL were derived from Western populations, with limited studies and guidelines on the management of CLL from an Asian population perspective. This consensus guideline aims to understand treatment challenges and suggest appropriate management approaches for CLL in the Asian population and other countries with a similar socio-economic profile. The following recommendations are based on a consensus by experts and an extensive literature review and contribute towards uniform patient care in Asia.
    Matched MeSH terms: Asia/epidemiology
  7. Asia-Pacific association for study of liver guidelines on management of ascites in liver disease
    Singh V, De A, Mehtani R, Angeli P, Maiwall R, Satapathy S, et al.
    Hepatol Int, 2023 Aug;17(4):792-826.
    PMID: 37237088 DOI: 10.1007/s12072-023-10536-7
    Matched MeSH terms: Asia/epidemiology
  8. The APLAR Gout Registry: A multinational collaboration to better understand people with gout in the Asia-Pacific
    Jatuworapruk K, De Vera R, Estrella AM, Sollano MHMZ, Vaidya B, Rahman MM, et al.
    Int J Rheum Dis, 2023 Aug;26(8):1432-1434.
    PMID: 37527022 DOI: 10.1111/1756-185X.14765
    Matched MeSH terms: Asia/epidemiology
  9. Fulltext Geographic Expansion of Banana Blood Disease in Southeast Asia
    Ray JD, Subandiyah S, Rincon-Florez VA, Prakoso AB, Mudita IW, Carvalhais LC, et al.
    Plant Dis, 2021 Oct;105(10):2792-2800.
    PMID: 33973808 DOI: 10.1094/PDIS-01-21-0149-RE
    Blood disease in bananas caused by Ralstonia syzygii subsp. celebesensis is a bacterial wilt causing significant crop losses in Indonesia and Malaysia. Disease symptoms include wilting of the plant and red-brown vascular staining, internal rot, and discoloration of green banana fruit. There is no known varietal resistance to this disease in the Musa genus, although variation in susceptibility has been observed, with the popular Indonesian cooking banana variety Kepok being highly susceptible. This study established the current geographic distribution of Blood disease in Indonesia and confirmed the pathogenicity of isolates by Koch's postulates. The long-distance distribution of the disease followed an arbitrary pattern indicative of human-assisted movement of infected banana materials. In contrast, local or short-distance spread radiated from a single infection source, indicative of dispersal by insects and possibly contaminated tools, water, or soil. The rapid expansion of its geographical range makes Blood disease an emerging threat to banana production in Southeast Asia and beyond.
    Matched MeSH terms: Asia, Southeastern
  10. Fulltext Prevalence of chronic kidney disease in Asia: a systematic review and analysis
    Liyanage T, Toyama T, Hockham C, Ninomiya T, Perkovic V, Woodward M, et al.
    BMJ Glob Health, 2022 Jan;7(1).
    PMID: 35078812 DOI: 10.1136/bmjgh-2021-007525
    INTRODUCTION: The burden of chronic kidney disease (CKD) is growing rapidly around the world. However, there is limited information on the overall regional prevalence of CKD, as well as the variations in national prevalence within Asia. We aimed to consolidate available data and quantify estimates of the CKD burden in this region.

    METHODS: We systematically searched MEDLINE, Embase and Google Scholar for observational studies and contacted national experts to estimate CKD prevalence in countries of Asia (Eastern, Southern and South Eastern Asia). CKD was defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 or the presence of proteinuria. For countries without reported data, we estimated CKD prevalence using agglomerative average-linkage hierarchical clustering, based on country-level risk factors and random effects meta-analysis within clusters. Published CKD prevalence data were obtained for 16 countries (of the 26 countries in the region) and estimates were made for 10 countries.

    RESULTS: There was substantial variation in overall and advanced (eGFR <30 mL/min/1.73 m2) CKD prevalence (range: 7.0%-34.3% and 0.1%-17.0%, respectively). Up to an estimated 434.3 million (95% CI 350.2 to 519.7) adults have CKD in Asia, including up to 65.6 million (95% CI 42.2 to 94.9) who have advanced CKD. The greatest number of adults living with CKD were in China (up to 159.8 million, 95% CI 146.6 to 174.1) and India (up to 140.2 million, 95% CI 110.7 to 169.7), collectively having 69.1% of the total number of adults with CKD in the region.

    CONCLUSION: The large number of people with CKD, and the substantial number with advanced CKD, show the need for urgent collaborative action in Asia to prevent and manage CKD and its complications.

    Matched MeSH terms: Asia/epidemiology; Asia, Southeastern
  11. The importance of assessment and management of morning stiffness in Asian patients with rheumatoid arthritis: Recommendations from an expert panel
    Mok CC, Cha HS, Hidayat R, Nguyen LT, Perez EC, Ramachandran R, et al.
    Int J Rheum Dis, 2016 Jan;19(1):30-7.
    PMID: 26403254 DOI: 10.1111/1756-185X.12755
    OBJECTIVE: In patients with rheumatoid arthritis (RA), morning stiffness is linked more to functional disability and pain than disease activity, as assessed by joint counts and markers of inflammation. As part of the Asia Pacific Morning Stiffness in Rheumatoid Arthritis Expert Panel, a group of eight rheumatologists met to formulate consensus points and develop recommendations for the assessment and management of morning stiffness in RA.
    METHODS: On the basis of a systematic literature review and expert opinion, a panel of Asian rheumatologists formulated recommendations for the assessment and medical treatment of RA.
    RESULTS: The panel agreed upon 10 consensus statements on morning stiffness, its assessment and treatment. Specifically, the panel recommended that morning stiffness, pain and impaired morning function should be routinely assessed in clinical practice. Although there are currently no validated tools for these parameters, they should be assessed as part of the patients' reported outcomes in RA. The panel also agreed on the benefits of low-dose glucocorticoids in RA, particularly for the improvement of morning stiffness.
    CONCLUSIONS: These recommendations serve to guide rheumatologists and other stakeholders on the assessment and management of morning stiffness, and help implement the treat-to-target principle in the management of RA.
    KEYWORDS: consensus recommendations; morning stiffness; rheumatoid arthritis
    Matched MeSH terms: Asia
  12. Fulltext The influence of firm age on the relationships of airline performance, economic situation and internal operation
    Ismail NA, Jenatabadi HS
    Transp Res Part A Policy Pract, 2014 Sep;67:212-224.
    PMID: 32288368 DOI: 10.1016/j.tra.2014.06.010
    The ways in which airline performance depends on the economic situation and internal operation are well established in the literature. One of the contextual factors that may change the nature of these relationships is firm age. As such, the aim of this study is to investigate the moderating influence of firm age on airline performance outcomes. Thirty airline companies from the Asia Pacific region were selected, and relevant data from 2006 to 2011 were collected. It can be deduced that company experience or firm age can help in taking control of the relationship between the constructs; thus, this measurement acts as a moderator in the research model.
    Matched MeSH terms: Asia
  13. Inhibition of Human Cytochrome P450 2c8-catalyzed Amodiaquine N-desethylation: Effect of Five Traditionally and Commonly Used Herbs
    Muthiah YD, Ong CE, Sulaiman SA, Ismail R
    Pharmacognosy Res, 2016 Oct-Dec;8(4):292-297.
    PMID: 27695271
    In Southeast Asia and many parts of the world, herbal products are increasingly used in parallel with modern medicine.
    Matched MeSH terms: Asia, Southeastern
  14. Overview of HIV molecular epidemiology among people who inject drugs in Europe and Asia
    Nikolopoulos GK, Kostaki EG, Paraskevis D
    Infect Genet Evol, 2016 Dec;46:256-268.
    PMID: 27287560 DOI: 10.1016/j.meegid.2016.06.017
    HIV strains continuously evolve, tend to recombine, and new circulating variants are being discovered. Novel strains complicate efforts to develop a vaccine against HIV and may exhibit higher transmission efficiency and virulence, and elevated resistance to antiretroviral agents. The United Nations Joint Programme on HIV/AIDS (UNAIDS) set an ambitious goal to end HIV as a public health threat by 2030 through comprehensive strategies that include epidemiological input as the first step of the process. In this context, molecular epidemiology becomes invaluable as it captures trends in HIV evolution rates that shape epidemiological pictures across several geographical areas. This review briefly summarizes the molecular epidemiology of HIV among people who inject drugs (PWID) in Europe and Asia. Following high transmission rates of subtype G and CRF14_BG among PWID in Portugal and Spain, two European countries, Greece and Romania, experienced recent HIV outbreaks in PWID that consisted of multiple transmission clusters including subtypes B, A, F1, and recombinants CRF14_BG and CRF35_AD. The latter was first identified in Afghanistan. Russia, Ukraine, and other Former Soviet Union (FSU) states are still facing the devastating effects of epidemics in PWID produced by AFSU (also known as IDU-A), BFSU (known as IDU-B), and CRF03_AB. In Asia, CRF01_AE and subtype B (Western B and Thai B) travelled from PWID in Thailand to neighboring countries. Recombination hotspots in South China, Northern Myanmar, and Malaysia have been generating several intersubtype and inter-CRF recombinants (e.g. CRF07_BC, CRF08_BC, CRF33_01B etc.), increasing the complexity of HIV molecular patterns.
    Matched MeSH terms: Asia/epidemiology
  15. Current status of filariasis in Southeast Asia. Proceedings of the 34th SEAMEO TROPMED regional semiar. Kuala Lumpur, Malaysia, 26-27 June 1992
    Southeast Asian J. Trop. Med. Public Health, 1993;24 Suppl 2:1-112.
    PMID: 7973936
    Matched MeSH terms: Asia, Southeastern/epidemiology
  16. [Asia: front-line country in the HIV epidemic]
    J Sykepleien, 1993 Jan 19;81(1):20.
    PMID: 8466793
    Matched MeSH terms: Asia/epidemiology
  17. National Policies and strategies on science and technology for development
    Ayob A
    Dev Forum, 1979.
    PMID: 12261806
    Matched MeSH terms: Asia; Asia, Southeastern
  18. Secondary prevention of fragility fractures in Asia Pacific: an educational initiative
    Ebeling PR, Chan DC, Lau TC, Lee JK, Songpatanasilp T, Wong SH, et al.
    Osteoporos Int, 2020 May;31(5):805-826.
    PMID: 31788717 DOI: 10.1007/s00198-019-05197-y
    The Asia -Pacific Bone Academy (APBA) Fracture Liaison Service (FLS) Focus Group educational initiative has stimulated activity across the Asia -Pacific region with the intention of supporting widespread implementation of new FLS. In 2017, the APBA FLS Focus Group developed a suite of tools to support implementation of FLS across the Asia-Pacific region as a component of a multi-faceted educational initiative. This article puts this initiative into context with a narrative review describing the burden of fragility fractures in the region, the current secondary fracture prevention care gap and a summary of emerging best practice. The results of a survey to evaluate the impact of the APBA educational initiative is presented, in addition to commentary on recent activities intended to improve the care of individuals who sustain fragility fractures across the Asia -Pacific. A FLS Toolbox for Asia-Pacific was developed which included the following sections:1. The burden of fragility fractures in the Asia-Pacific region.2. A summary of evidence for FLS in the Asia-Pacific.3. A generic, fully referenced FLS business plan template.4. Potential cost savings accrued by each country, based on a country-specific FLS Benefits Calculator.5. How to start and expand FLS programmes in the Asia-Pacific context.6. A step-by-step guide to setting up FLS in countries in the Asia-Pacific region.7. Other practical tools to support FLS establishment.8. FLS online resources and publications.The FLS Toolbox was provided as a resource to support FLS workshops immediately following the 5th Scientific Meeting of the Asian Federation of Osteoporosis Societies (AFOS) held in Kuala Lumpur in October 2017. The FLS workshops addressed three key themes:• The FLS business case.• Planning the FLS patient pathway.• The role of the FLS coordinator in fragility fracture care management.A follow-up survey of 142 FLS workshop participants was conducted in August-September 2018. The survey included questions regarding how FLS were developed, funded, the scope of service provision and the support provided by the educational initiative. Almost one-third (30.3%) of FLS workshop participants completed the survey. Survey responses were reported for those who had established a FLS at the time the survey was conducted and, separately, for those who had not established a FLS. Findings for those who had established a FLS included:• 78.3% of respondents established a multidisciplinary team to develop the business case for their FLS.• 87.0% of respondents stated that a multidisciplinary team was established to design the patient pathway for their FLS.• 26.1% of respondents stated that their FLS has sustainable funding.• The primary source of funding for FLS was from public hospitals (83.3%) as compared with private hospitals (16.7%).Most hospitals that had not established a FLS at the time the survey was conducted were either in the process of setting-up a FLS (47%) or had plans in place to establish a FLS for which approval is being sought (29%). The primary barrier to establishing a new FLS was lack of sustainable funding. The APBA FLS Focus Group educational initiative has stimulated activity across the Asia-Pacific region with the intention of supporting widespread implementation of new FLS. A second edition of the FLS Toolbox is in development which is intended to complement ongoing efforts throughout the region to expedite widespread implementation of FLS.
    Matched MeSH terms: Asia/epidemiology
  19. Fulltext Prevalence of Alpha(α)-Thalassemia in Southeast Asia (2010-2020): A Meta-Analysis Involving 83,674 Subjects
    Goh LPW, Chong ETJ, Lee PC
    Int J Environ Res Public Health, 2020 10 09;17(20).
    PMID: 33050119 DOI: 10.3390/ijerph17207354
    Alpha(α)-thalassemia is a blood disorder caused by many types of inheritable α-globin gene mutations which causes no-to-severe clinical symptoms, such as Hb Bart's hydrops fetalis that leads to early foetal death. Therefore, the aim of this meta-analysis was to provide an update from year 2010 to 2020 on the prevalence of α-thalassemia in Southeast Asia. A systematic literature search was performed using PubMed and SCOPUS databases for related studies published from 2010 to 2020, based on specified inclusion and exclusion criteria. Heterogeneity of included studies was examined with the I2 index and Q-test. Funnel plots and Egger's tests were performed in order to determine publication bias in this meta-analysis. Twenty-nine studies with 83,674 subjects were included and pooled prevalence rates in this meta-analysis were calculated using random effect models based on high observed heterogeneity (I2 > 99.5, p-value < 0.1). Overall, the prevalence of α-thalassemia is 22.6%. The highest α-thalassemia prevalence was observed in Vietnam (51.5%) followed by Cambodia (39.5%), Laos (26.8%), Thailand (20.1%), and Malaysia (17.3%). No publication bias was detected. Conclusions: This meta-analysis suggested that a high prevalence of α-thalassemia occurred in selected Southeast Asia countries. This meta-analysis data are useful for designing thalassemia screening programs and improve the disease management.
    Matched MeSH terms: Asia, Southeastern/epidemiology
  20. Fulltext Asia-Pacific perspectives on the COVID-19 pandemic
    Pawankar R, Thong BY, Tiongco-Recto M, Wang JY, Abdul Latiff AH, Thien F, et al.
    Allergy, 2021 09;76(9):2998-2901.
    PMID: 33948966 DOI: 10.1111/all.14894
    Matched MeSH terms: Asia/epidemiology
Related Terms
Filters
Contact Us

Please provide feedback to Administrator (afdal@afpm.org.my)

External Links