Displaying all 11 publications

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  1. Sengupta P, Chatterjee B, Tekade RK
    Int J Pharm, 2018 May 30;543(1-2):328-344.
    PMID: 29635054 DOI: 10.1016/j.ijpharm.2018.04.007
    Different regulatory guidelines recommend establishing stability profile of pharmaceuticals at the time of drug development. The expiry date, retesting period and storage conditions of active drugs or products are established through stability analysis. Several regulatory guidelines exist for stability testing of pharmaceuticals. Mostly, ICH stability guidelines are followed in practice. This guideline recommends to validate stability indicating method using forced degradation samples that contains all possible degradation impurities. ICH guidelines provide general recommendations for inclusion of stability indicating parameters in a stability testing protocol. However, those guidelines do not provide specific requirements and experimental methodology to be followed for stability studies. Due to this gap, often confusion arises in the scientific community in designing stability testing protocol. Therefore, significant variations are observed in reported literature in selection of stability indicating parameters. Procedural dissimilarity amongst reported stability studies is also evident. This review discusses the regulatory guidelines and procedures to follow in performing stability testing of pharmaceuticals. Scope of this review also includes recommendations on practical approaches for designing stability testing protocol to fulfill current regulatory requirements for drug substances and their formulations.
    Matched MeSH terms: Legislation, Drug*
  2. Ahmad A, Khan MU, Balkrishnan R
    Lancet Glob Health, 2016 08;4(8):e521.
    PMID: 27443777 DOI: 10.1016/S2214-109X(16)30093-6
    Matched MeSH terms: Legislation, Drug*
  3. Abas A
    Biologicals, 2011 Sep;39(5):339-42.
    PMID: 21784655 DOI: 10.1016/j.biologicals.2011.06.009
    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products.
    Matched MeSH terms: Legislation, Drug/standards*
  4. Vicknasingam B, Narayanan S, Singh D, Corazza O
    Curr Opin Psychiatry, 2020 07;33(4):295-300.
    PMID: 32398543 DOI: 10.1097/YCO.0000000000000612
    PURPOSE OF REVIEW: The aim of this review is to provide an update on recent trends of New Psychoactive Substances (NPS) and the current global strategies implemented to manage them.

    RECENT FINDINGS: The number of NPS has increased from 166 in 2009 to 892 in 2018, with about 36% having stimulant effects. Such trend revels some unprecedented patterns. The decline in the emergence of new synthetic cannabinoids has coincided with rising deaths due to overdose of fentanyl and non-fentanyl compounds in North America and Europe. The detection of new stimulant NPS has stabilized since 2015. Although the level of seizures of mephedrone have risen since then, they are still below the levels reported before international control. The legal status of kratom still remains unclear, whereas calls for research on its benefits continue. The nonmedical use of tramadol in Africa and Middle East is a cause of growing concern.

    SUMMARY: Although the rise of NPS is a cause for concern, evidence suggests that the strategy to face the challenge should include updating international data collection systems, integrating scientific-based interventions for drug use, strengthening national monitoring, and increasing collaborative research and forensic capabilities. The legal, regulatory framework and clinical guidelines should remain dynamic, whereas enforcement agencies should measure success by destroying drug networks as seizures rarely dismantle drug markets.

    Matched MeSH terms: Legislation, Drug*
  5. Murayama A, Ueda M, Shrestha S, Tanimoto T, Ozaki A
    Cancer Cell, 2021 09 13;39(9):1165-1166.
    PMID: 34358449 DOI: 10.1016/j.ccell.2021.07.008
    Matched MeSH terms: Legislation, Drug/organization & administration*
  6. Abubakar U, Tangiisuran B
    Int J Clin Pharm, 2020 Apr;42(2):756-764.
    PMID: 32270378 DOI: 10.1007/s11096-020-01019-y
    Background Non-prescription dispensing of antibiotics is common in Nigeria and this could contribute to the emergence of microbial resistance. Objectives To evaluate knowledge, perception and practices of community pharmacists towards dispensing antibiotics without prescription. Setting Community pharmacies in two cities in Northern Nigeria. Methods A prospective cross-sectional study was conducted among community pharmacists in two cities in Northern Nigeria, using a validated and pilot-tested questionnaire. The questionnaire was self-administered and data was collected between 06th April and 31st May 2019. The data was analyzed using descriptive and inferential analyses. Main outcome measure Knowledge, perception and practices towards dispensing antibiotics without prescription. Results A total of 98 out of 130 community pharmacists completed and returned the questionnaire (response rate: 75.3%). About two-third (64.3%) of the community pharmacists were aware that dispensing antibiotics without prescription is illegal. However, this malpractice was common as 39.7% of the respondents indicated that they dispensed antibiotics without prescription five times or more in a day. Antibiotics dispensed without prescription were used for the treatment of urinary tract infections (83.7%), typhoid fever (83.7%) and sexually transmitted infections (66.3%). Pharmacist's confidence in knowledge of antibiotic therapy was the most common reason for non-prescription dispensing of antibiotics. Respondents with less than 5 years of working experience (66.7%) were significantly more likely to dispense antibiotics without prescription 5 times or more in a day compared to those with more than 5 years community pharmacy experience (33.3%), P = 0.031. Conclusion Non-prescription dispensing of antibiotics was common among community pharmacists despite awareness about its prohibition and implications. The malpractice was associated with number of years of community pharmacy experience. Confidence in knowledge of antibiotic therapy was the main reason community pharmacists dispensed antibiotics without prescription. Continuous pharmacy education and training on handling of antibiotics may help to reduce inappropriate practices among community pharmacists.
    Matched MeSH terms: Legislation, Drug/standards
  7. Iqbal MZ, Qadir MI, Hussain T, Janbaz KH, Khan YH, Ahmad B
    Pak J Pharm Sci, 2014 Mar;27(2):405-15.
    PMID: 24577933
    Joint FAO/WHO expert's consultation report defines probiotics as: Live microorganisms which when administered in adequate amounts confer a health benefit on the host. Most commonly used probiotics are Lactic acid bacteria (LAB) and bifidobacteria. There are other examples of species used as probiotics (certain yeasts and bacilli). Probiotic supplements are popular now a days. From the beginning of 2000, research on probiotics has increased remarkably. Probiotics are now day's widely studied for their beneficial effects in treatment of many prevailing diseases. Here we reviewed the beneficiary effects of probiotics in some diseases.
    Matched MeSH terms: Legislation, Drug
  8. Shetty P
    Lancet, 2013 Jun 15;381(9883):2073.
    PMID: 23769222 DOI: 10.1016/S0140-6736(13)61231-3
    Matched MeSH terms: Legislation, Drug
  9. Arokiasamy CM, Taricone PF
    Int J Addict, 1992 Nov;27(11):1301-11.
    PMID: 1332927
    West Malaysia has had a long history of drug use, beginning as early as the 1800s. While early use was primarily restricted to Chinese coolies and Indian immigrant laborers, the 1970s saw drug use become the domain of the youth of Malaysia and achieve the proportions of a national crisis. This paper traces the early origins of drug use and misuse in Malaysia, its development and expansion during the 1970s and the current efforts at eradication and rehabilitation. This examination of Malaysian efforts in response to the spread of drug use or misuse may provide researchers and practitioners in other countries some historical and cross cultural perspectives on current international efforts at eradicating similar problems.
    Matched MeSH terms: Legislation, Drug
  10. Subin TS, Vijayan V, Kumar KJR
    Pharm Nanotechnol, 2017;5(3):180-191.
    PMID: 28641516 DOI: 10.2174/2211738505666170615095542
    BACKGROUND: Nanomedicine is a branch which deals with medicinal products, devices, nonbiological complex drugs and antibody-nanoparticle conjugates and general health products that are manufactured using nanotechnology.

    OBJECTIVE: Nano-medicine provides the same efficacies as traditional medicines owing to their improved solubility and bioavailability with reduced dosages. However, there are currently safety concerns due to the difficulties related to nanomaterial characterization; this might be the reason for unawareness of such medicines among the patients. The absence of clear regulatory guidelines further complicates matters, as it makes the path to registering them with regulatory bodies difficult. However, some products have overcome these obstacles and have been registered. While there are many international initiatives to harmonize the regulatory requirements and helps the industry to determine the most important characteristics that influence in vivo product performance.

    CONCLUSION: This review focuses on the various types of nanopharmaceuticals, and developments process with strategies tailored to upcoming regulations may satisfy the patients' needs.

    Matched MeSH terms: Legislation, Drug
  11. Perehudoff SK, Alexandrov NV, Hogerzeil HV
    PLoS One, 2019;14(6):e0215577.
    PMID: 31251737 DOI: 10.1371/journal.pone.0215577
    Persistent barriers to universal access to medicines are limited social protection in the event of illness, inadequate financing for essential medicines, frequent stock-outs in the public sector, and high prices in the private sector. We argue that greater coherence between human rights law, national medicines policies, and universal health coverage schemes can address these barriers. We present a cross-national content analysis of national medicines policies from 71 countries published between 1990-2016. The World Health Organization's (WHO) 2001 guidelines for developing and implementing a national medicines policy and all 71 national medicines policies were assessed on 12 principles, linking a health systems approach to essential medicines with international human rights law for medicines affordability and financing for vulnerable groups. National medicines policies most frequently contain measures for medicines selection and efficient spending/cost-effectiveness. Four principles (legal right to health; government financing; efficient spending; and financial protection of vulnerable populations) are significantly stronger in national medicines policies published after 2004 than before. Six principles have remained weak or absent: pooling user contributions, international cooperation, and four principles for good governance. Overall, South Africa (1996), Indonesia and South Sudan (2006), Philippines (2011-2016), Malaysia (2012), Somalia (2013), Afghanistan (2014), and Uganda (2015) include the most relevant texts and can be used as models for other settings. We conclude that WHO's 2001 guidelines have guided the content and language of many subsequent national medicines policies. WHO and national policy makers can use these principles and the practical examples identified in our study to further align national medicines policies with human rights law and with Target 3.8 for universal access to essential medicines in the Sustainable Development Goals.
    Matched MeSH terms: Legislation, Drug
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