Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 5.839
Filter
1.
Clin Geriatr Med ; 38(1): 99-118, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34794706

ABSTRACT

Over-the-counter (OTC) products such as pharmaceuticals, dietary supplements, vitamins, and herbal remedies are widely available and copiously used by older adults for health maintenance and symptom management. Owing to physiology, multimorbidity, and polypharmacy, this population is particularly vulnerable to inappropriate use of OTC products, adverse effects, and drug interactions. While OTC pharmaceuticals are bound by FDA-approved standards, dietary supplements are regulated differently, resulting in variable quality and increased possibility for adulteration. Internationally, standards for OTC products vary widely. Accessible educational information, improved provider-patient communication, and revision of regulatory policy could improve safety for older adult users of OTC products.

2.
Medicina (Kaunas) ; 57(11)2021 Nov 05.
Article in English | MEDLINE | ID: mdl-34833426

ABSTRACT

Pain management is a crucial issue for athletes who train and compete at the highest performance levels. There are still evidence gaps for the use of analgesics for sports injuries despite the growing interest in training and competition settings. However, high-quality research is needed to determine the most appropriate and optimal timing and formulations in non-steroidal anti-inflammatory drug and opioid management, particularly given the strictness of anti-doping regulations. Indeed, the role of pharmacological therapy in reducing acute traumatic pain in athletes should still be addressed to minimize the timing of return to sport. Therefore, the aim of this comprehensive review was to summarize the current evidence about pain management in the setting of acute injury in elite athletes, providing the most informed strategy for pain relief and performance recovery.


Subject(s)
Athletic Injuries , Musculoskeletal Pain , Sports , Athletes , Athletic Injuries/complications , Athletic Injuries/drug therapy , Humans , Musculoskeletal Pain/drug therapy , Musculoskeletal Pain/etiology , Pain Management
3.
Environ Mol Mutagen ; 62(9): 512-525, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34775645

ABSTRACT

We present a hypothetical case study to examine the use of a next-generation framework developed by the Genetic Toxicology Technical Committee of the Health and Environmental Sciences Institute for assessing the potential risk of genetic damage from a pharmaceutical perspective. We used etoposide, a genotoxic carcinogen, as a representative pharmaceutical for the purposes of this case study. Using the framework as guidance, we formulated a hypothetical scenario for the use of etoposide to illustrate the application of the framework to pharmaceuticals. We collected available data on etoposide considered relevant for assessment of genetic toxicity risk. From the data collected, we conducted a quantitative analysis to estimate margins of exposure (MOEs) to characterize the risk of genetic damage that could be used for decision-making regarding the predefined hypothetical use. We found the framework useful for guiding the selection of appropriate tests and selecting relevant endpoints that reflected the potential for genetic damage in patients. The risk characterization, presented as MOEs, allows decision makers to discern how much benefit is critical to balance any adverse effect(s) that may be induced by the pharmaceutical. Interestingly, pharmaceutical development already incorporates several aspects of the framework per regulations and health authority expectations. Moreover, we observed that quality dose response data can be obtained with carefully planned but routinely conducted genetic toxicity testing. This case study demonstrates the utility of the next-generation framework to quantitatively model human risk based on genetic damage, as applicable to pharmaceuticals.

4.
Article in English | MEDLINE | ID: mdl-34755214

ABSTRACT

Bacteria belonging to the Burkholderia genus are extremely versatile and diverse. They can be environmental isolates, opportunistic pathogens in cystic fibrosis, immunocompromised or chronic granulomatous disease patients, or cause disease in healthy people (e.g., Burkholderia pseudomallei) or animals (as in the case of Burkholderia mallei). Since the genus was separated from the Pseudomonas one in the 1990s, the methodological tools to study and characterize these bacteria are evolving fast. Here we reviewed the techniques used in the last few years to update the taxonomy of the genus, to study gene functions and regulations, to deepen the knowledge on the drug resistance which characterizes these bacteria, and to elucidate their mechanisms to establish infections. The availability of these tools significantly impacts the quality of research on Burkholderia and the choice of the most appropriated is fundamental for a precise characterization of the species of interest.Key points• Updated techniques to study the genus Burkholderia were reviewed.• Taxonomy, genomics, assays, and animal models were described.• A comprehensive overview on recent advances in Burkholderia studies was made.

5.
Article in English | MEDLINE | ID: mdl-34763368

ABSTRACT

BACKGROUND: Supply chain management is essential for cold chain medicines since they are temperature-controlled and must be maintained within a specific temperature range to ensure product integrity and quality. In Nigeria, guidelines that address drug distribution do not adequately address the issue of cold chain management in addition to challenges in implementation. Given the chaotic medicines distribution system, this study examined the quality of practice of supply chain management of cold chain products in line with the World Health Organisation's Expert Committee report on Specifications for Pharmaceutical Preparations. METHODS: The study was set in Abuja Nigeria and descriptive survey was used to explore cold chain supply management. A checklist developed from regulatory requirements stipulated by the World Health Organisation covering documentations, storage and distribution guidelines was used to assess supply chain management of cold chain medicines across various facilities. Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 25. RESULTS: The results from this study showed that most of the storage facilities assessed (66.7%) did not meet up to the required standards of quality management for cold chain products. In addition, 50.4% of retail and hospital pharmacy facilities performed poorly in cold chain management practices. Many of aspects of quality management guidelines and regulations were not met by the facilities. Most facilities (66.7%) do not have their equipment calibrated, 43.6% of the hospital and retail pharmacies assessed do not have an automated system to cater for power failure while 37.6% do not perform a temperature check on cold chain products before receiving from suppliers. CONCLUSION: The study has shown that the levels of the supply chain assessed for quality management and regulatory compliance performed poorly. There was limited availability and use of validated quality monitoring systems for cold chain medicines in these facilities.

6.
Cad. Ibero Am. Direito Sanit. (Impr.) ; 10(4): 84-98, out.-dez.2021.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1344343

ABSTRACT

Introducción: el derecho al acceso a la información administrativa es un derecho fundamental consagrado en la Constitución Política de Costa Rica. La información que presentan las empresas respecto a seguridad, calidad y eficacia para que se otorgue la aprobación para comercializar un medicamento en el país por parte del Estado es necesaria para un usoracional de los medicamentos. Objetivo: determinar si la población costarricense tiene acceso a la información pública del registro sanitario de un medicamento. Metodología: consistió en la revisión detallada de la normativa nacional relacionada con acceso a la información pública y su aplicaciónpara los expedientes de registros sanitarios en el país. Resultados: según la legislación nacional esta información es de acceso público, excepto algunos datos de sustancias nuevas. Sin embargo, el Ministerio de Salud de Costa Rica no permite que la ciudadanía conozca esta información, al no disponer de una base de datos pública, de acceso en tiempo real, a partir de una plataforma digital. Conclusión: existe una violación del derecho fundamental a acceder a la información administrativa por parte del Ministerio de Salud de Costa Rica.


Introduction: the right of access to administrative information is a fundamental right enshrined in the Political Constitution of Costa Rica. The information that companies present regarding safety, quality,and efficacy forthe State to grant approval to market a drug in the country is necessary for a rational use ofdrugs. Objective: To determine if the Costa Rican population has access to the public information of the sanitary registry of a medicine. Methods: a detailed review of the national regulations related to access to public information was made and its application to the records of health records in the country. Results: According to national legislation, this information is publicly accessible, except for data on new substances. However, the Costa Rican Ministry of Health does not allow citizens to know this information, as it does not have a public database, accessible in real time, from a digital platform. Conclusion: there is a violation of the fundamental right to access administrative information by the Ministry of Health of Costa Rica.


Introdução: o direito de acesso à informação administrativa é um direito fundamental consagrado na Constituição Política da Costa Rica. As informações que as empresas apresentam sobre segurança, qualidade e eficácia para que o Estado conceda a aprovação para comercialização de um medicamento no país são necessárias para o uso racional dos medicamentos. Objetivo: determinar se a população costarriquenha tem acesso às informações públicas do registro sanitário de um medicamento. Metodologia: consistiu em uma revisão detalhada das regulamentações nacionais relacionadas ao acesso à informação pública e sua aplicação aos registros dos prontuários de saúde do país. Resultados: de acordo com a legislação nacional, essa informação está acessível ao público, exceto para alguns dados sobre novas substâncias. No entanto, o Ministério da Saúde da Costa Rica não permite que os cidadãos conheçam essas informações, pois não possui um banco de dados público, acessível em tempo real, a partir de uma plataforma digital. Conclusão: há uma violação do direito fundamental de acesso à informação administrativa por parte do Ministério da Saúde da Costa Rica.

7.
Stem Cells Transl Med ; 10 Suppl 2: S18-S30, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34724720

ABSTRACT

Mesenchymal stem/stromal cells (MSCs) have broad application prospects for regenerative medicine due to their self-renewal, high plasticity, ability for differentiation, and immune response and modulation. Interest in turning MSCs into clinical applications has never been higher than at present. Many biotech companies have invested great effort from development of clinical grade MSC product to investigational new drug (IND) enabling studies. Therefore, the growing demand for publication of MSC regulation in China necessitates various discussions in accessible professional journals. The National Medical Products Administration has implemented regulations on the clinical application of MSCs therapy. The regulations for MSCs products as drug have been updated in recent years in China. This review will look over the whole procedure in allogeneic MSC development, including regulations, guidance, processes, quality management, pre-IND meeting, and IND application for obtaining an approval to start clinical trials in China. The review focused on process and regulatory challenges in the development of MSCs products, with the goal of providing strategies to meet regulatory demands. This article describes a path for scientists, biotech companies, and clinical trial investigators toward the successful development of MSC-based therapeutic product.

8.
Toxicol Appl Pharmacol ; 433: 115779, 2021 Dec 15.
Article in English | MEDLINE | ID: mdl-34737146

ABSTRACT

The Delaney Clause of the Federal Food, Drug, and Cosmetic Act became law in 1958 because of concerns that potentially harmful chemicals were finding their way into foods and causing cancer. It states, "[n]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." The United States Food and Drug Administration (US FDA) and United States Environmental Protection Agency (US EPA, prior to implementation of the Food Quality Protection Act) were charged with implementing this clause. Over 60 years, advances in cancer research have elucidated how chemicals induce cancer. Significant advancements in analytical methodologies have allowed for accurate and progressively lower detection limits, resulting in detection of trace amounts. Based on current scientific knowledge, there is a need to revisit the Delaney Clause's utility. The lack of scientific merit to the Delaney Clause was very apparent when recently the US FDA had to revoke the food additive approvals of 6 synthetic flavoring substances because high dose testing in animals demonstrated a carcinogenic response. However, US FDA determined that these 6 synthetic flavoring substances do not pose a risk to public health under the conditions of intended use. The 7th substance, styrene, was de-listed because it is no longer used by industry. The scientific community is committed to improving public health by promoting relevant science in risk assessment and regulatory decision making, and this was discussed in scientific sessions at the American Association for the Advancement of Science (AAAS) 2020 Annual Meeting and the Society of Toxicology (SOT) 2019 Annual Meeting. Expert presentations included advances in cancer research since the 1950s; the role of the Delaney Clause in the current regulatory paradigm with a focus on synthetic food additives; and the impact of the clause on scientific advances and regulatory decision making. The sessions concluded with panel discussions on making the clause more relevant based on 21st-century science.

9.
Ann Pharm Fr ; 2021 Oct 29.
Article in English | MEDLINE | ID: mdl-34756928

ABSTRACT

In 2015, JFDA approved its biosimilars registration guidelines [1] officially. Many steps have been taken before achieving this progress. This paper summarizes briefly JFDA efforts that were done in the previous years and the actions taken to approve JFDA biosimilars registration guidance which was based on EMA related guidelines [2-5], and its impact on enhancing the affordability of safe, effective and high quality biosimilars for patients.

10.
Washington, D.C.; PAHO; 2021-10-14.
Non-conventional in English | PAHO-IRIS | ID: phr-54995

ABSTRACT

The acquisition of antimicrobials without a prescription is a global concern. This practice is thriving in countries that lack adequate legislation or where regulations are not properly enforced. The Pan American Health Organization (PAHO) and its member states in the Region of the Americas approved the Global Action Plan on Antimicrobial Resistance, which recognizes antimicrobial resistance as a threat to global public health that requires a multisectoral response. To tackle antimicrobial resistance, a worldwide change in behavior is needed in terms of how these drugs are used and acquired. National approaches are required to address the indiscriminate use and over-prescription of antimicrobials, and to enforce regulations on prescription and acquisition practices. The objective of this communication handbook is to help communication professionals and health program officials develop strategies to raise awareness and promote the importance of the appropriate use of antimicrobials among different stakeholders; raise public awareness about the importance of obtaining antimicrobials with a prescription in order to achieve multisectoral collaboration to ensure compliance with laws and regulations on this issue; and promote a change in behavior regarding the appropriate use and acquisition of antimicrobials by everyone involved. The target audiences for this handbook are the general population (including adolescents, children, and child caregivers/parents of children), healthcare professionals (including pharmacists and pharmacy staff), and various stakeholders (government officials, professional societies, medical organizations, the private sector, local leaders, and health-influencers, among others).


Subject(s)
Drug Resistance , Drug Resistance, Microbial , Medicine , Access to Essential Medicines and Health Technologies , Health Sciences, Technology, and Innovation Management , Health Systems , Public Health , National Health Programs
11.
J Healthc Eng ; 2021: 4016346, 2021.
Article in English | MEDLINE | ID: mdl-34659685

ABSTRACT

Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.

12.
BMJ Open ; 11(10): e051277, 2021 10 18.
Article in English | MEDLINE | ID: mdl-34663661

ABSTRACT

OBJECTIVE: To evaluate pharmacists' knowledge, perceptions and practices towards generic substitution in the 11 pilot locations in China. DESIGN: An online cross-sectional survey using questionnaires was conducted. A convenience sampling technique was implemented to recruit pharmacists. SETTING AND PARTICIPANTS: The study took place in medical institutions of 11 pilot locations that participated in the pilot national centralised procurement programme in 2019. Two thousand two hundred and ninety-one pharmacists including hospital pharmacists or community pharmacists based on health-systems or clinics participated in the study. RESULTS: Most of the participants had the good knowledge of requirements for evaluating the quality and efficacy of generic drugs (n=2118; 92.4%), and the definition of generic drugs (n=2078; 90.7%). In terms of perceptions, 67.3% of respondents were of the opinion that generic drugs are equally as effective as the brand-name drugs, and 69.0% of respondents were of the opinion that generic drugs are as safe as brand equivalents. A high percentage of participants supported the policy of generic substitution (n=1634; 71.4%). A significant positive correlation was demonstrated between total knowledge score and total perception score (ρ=0.267; p<0.001). Efficacy, safety and the direction of national policies and hospital regulations were the main factors affecting pharmacists' willingness to dispense generic drugs. CONCLUSIONS: The study identified gaps in respondents' knowledge and perceptions of generic substitution. Pharmacists who are more knowledgeable in generic drugs tend to hold a more supportive attitude towards generic substitution. Although it appeared that pharmacists in China have largely accepted generic substitution, they still have concerns regarding the reliability and quality of generic drugs. The current issues need to be addressed for the realisation of the true value of generic drugs as part of the country's healthcare cost-containment strategy as well as the implementation of generic substitution policy in China.


Subject(s)
Drug Substitution , Pharmacists , Cross-Sectional Studies , Health Knowledge, Attitudes, Practice , Humans , Perception , Reproducibility of Results
13.
Arch Dermatol Res ; 2021 Oct 26.
Article in English | MEDLINE | ID: mdl-34698896

ABSTRACT

BACKGROUND: Medications may be specially prepared, or "compounded," to meet the needs of patients who cannot use standard formulation. The United States Pharmacopeia (USP) Convention is a private, nongovernmental organization which independently develops guidelines for pharmaceuticals. The purpose of this survey study is to better understand the extent to which state boards of pharmacy currently incorporate relevant USP guidelines into their compounding regulations. METHODS AND FINDINGS: Executive directors or other administrative representatives of each state board of pharmacy were invited to respond to six open-ended questions. Their free text responses were analyzed by two reviewers (KR, SI) using qualitative research techniques. The response rate was 71% (36/51). Almost all (35/36, 97%) indicated that they implement USP compounding standards at least in part. Eighteen boards (18/28, 64%) reported that 'some, but not all standards' are enforced, most commonly < 795 > and < 797 > , but not < 800 > (9/28, 32%). Ten (10/28, 36%) indicated that 'all' USP compounding standards are enforced. Eighteen (18/21, 86%) only implement finalized USP standards, whereas three consider newly proposed chapters (3/21, 14%). Over half (22/36, 61%) employ a committee or similar process to select standards. CONCLUSIONS: Almost all responding state boards of pharmacy incorporate finalized USP compounding standards into their regulations, usually via a formal rulemaking process, with boards commonly implementing some standards but not all. Chapters < 795 > and < 797 > are implemented more commonly than < 800 > . Since Congress passed the Drug Quality and Security Act (DQSA), pharmacy boards are becoming increasingly observant of USP compounding standards.

15.
Indian J Endocrinol Metab ; 25(2): 142-147, 2021.
Article in English | MEDLINE | ID: mdl-34660243

ABSTRACT

Objectives: High prevalence of vitamin D deficiency mandates prescribing an appropriate form of vitamin D that allows attainment of sufficiency in a cost-effective manner. We aimed to compare vitamin D products in Indian market in terms of composition and cost in 2020 with 2013 to understand price dispersion over 7 years. Methods: Constituents, formulations, and prices of 'branded' and generic vitamin D products were sourced from various drug information compendia and online sources. Price per defined daily dose (DDD), percentage cost variation, and change in prices over 7 years (2020 vs. 2013) was determined. Results: There has been a disproportionate increase in the number of brands and cost variation of cholecalciferol and calcitriol in the last 7 years. The percentage cost variation increased almost 10 times for calcitriol and 4.4 times for alfacalcidiol tablets and cholecalciferol granules. An analysis of >1,100 products in 2020 showed that the predominant form was calcitriol which was combined with calcium in >90% of the products with huge cost variation (>3000%). Ergocalciferol and cholecalciferol were available in 22 and 15 different strengths respectively. Median price/unit of cholecalciferol (60,000IU) was lower for tablets/capsules compared to other formulations; but with >1000% cost variation. Conclusion: A wide cost variation exists with the use of different vitamin D brands and preparations with conventional cholecalciferol tablets and capsules being a low-priced alternative. Quality control measures and strict enforcements of existing regulations are essential to ensure that competitive prices of branded generics are translated into availability and affordability for the population.

16.
Graefes Arch Clin Exp Ophthalmol ; 259(12): 3561-3567, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34669026

ABSTRACT

PURPOSE: Blindness and vision loss are still frequent disabilities associated with a relevant impact on health care and quality of life, and a high economic burden. Supranational programs established by the World Health Organization (WHO), International Agency for the Prevention of Blindness (IAPB), and World Health Assembly (WHA) aim at reducing avoidable visual impairment. Age-related macular degeneration (AMD), diabetic retinopathy (DR), and other retinal diseases are well known causes of visual disability. Since more than a decade, intravitreal agents are available for the treatment of these diseases. The aim of this study is to review whether pharmacotherapy with anti-vascular endothelial growth factor (VEGF) drugs has led to a decrease in the prevalence of blindness with emphasis on AMD and different countries. A brief analysis of other factors correlated to changes in the rate of blindness is also presented. METHODS: PubMed and Scopus web platforms were used to identify relevant studies on epidemiology of blindness and vision impairment, the influence of intravitreal therapies, and the existence of different vision care models. Additional data and material was searched in web internet accessed by the web browser Firefox. RESULTS: Age-standardized prevalence of blindness secondary to AMD has started to decline as testified by a number of studies in different countries. This is due to the adoption of anti-VEGF therapy and its adequate management. The frequency of treatment and regimens applied are indirect signs of successful treatment. Local rules and regulations may represent an obstacle. CONCLUSIONS: This review shows that by implementing existing health care systems and dispensing adequate therapies in the field of retinal diseases, the prevalence of blindness due to these conditions can decline.


Subject(s)
Macular Degeneration , Quality of Life , Angiogenesis Inhibitors/therapeutic use , Blindness/epidemiology , Blindness/etiology , Blindness/prevention & control , Humans , Macular Degeneration/drug therapy , Macular Degeneration/epidemiology , Vascular Endothelial Growth Factors , Visual Acuity
17.
J Biol Chem ; 297(4): 101187, 2021 10.
Article in English | MEDLINE | ID: mdl-34520757

ABSTRACT

The human AAA+ ATPase p97, also known as valosin-containing protein, a potential target for cancer therapeutics, plays a vital role in the clearing of misfolded proteins. p97 dysfunction is also known to play a crucial role in several neurodegenerative disorders, such as MultiSystem Proteinopathy 1 (MSP-1) and Familial Amyotrophic Lateral Sclerosis (ALS). However, the structural basis of its role in such diseases remains elusive. Here, we present cryo-EM structural analyses of four disease mutants p97R155H, p97R191Q, p97A232E, p97D592N, as well as p97E470D, implicated in resistance to the drug CB-5083, a potent p97 inhibitor. Our cryo-EM structures demonstrate that these mutations affect nucleotide-driven allosteric activation across the three principal p97 domains (N, D1, and D2) by predominantly interfering with either (1) the coupling between the D1 and N-terminal domains (p97R155H and p97R191Q), (2) the interprotomer interactions (p97A232E), or (3) the coupling between D1 and D2 nucleotide domains (p97D592N, p97E470D). We also show that binding of the competitive inhibitor, CB-5083, to the D2 domain prevents conformational changes similar to those seen for mutations that affect coupling between the D1 and D2 domains. Our studies enable tracing of the path of allosteric activation across p97 and establish a common mechanistic link between active site inhibition and defects in allosteric activation by disease-causing mutations and have potential implications for the design of novel allosteric compounds that can modulate p97 function.


Subject(s)
Mutation, Missense , Valosin Containing Protein/chemistry , Allosteric Regulation , Amino Acid Substitution , Amyotrophic Lateral Sclerosis/genetics , Amyotrophic Lateral Sclerosis/metabolism , Cryoelectron Microscopy , Humans , Protein Domains , Valosin Containing Protein/genetics , Valosin Containing Protein/metabolism
18.
Foods ; 10(9)2021 Sep 16.
Article in English | MEDLINE | ID: mdl-34574310

ABSTRACT

Food safety is imperative, especially for infants and young children because of their underdeveloped immune systems. This requires adequate nutritious food with appropriate amounts of macro- and micronutrients. Currently, a well-established system for infant food is enforced by the regulatory bodies, but no clear system exists for complementary food, which is consumed by children from the age of 6 month to 24 months. As the child grows beyond 6 months, the need for nutrients increases, and if the nutritional needs are not fulfilled, it can lead to health problems, such as stunted growth, weak immune system, and cardiovascular diseases. Hence, it is important to have regulatory bodies monitoring complementary food in a similar capacity as is required for infant formula. The objective of this review is to provide an overview of the existing regulatory bodies, such as the Codex Alimentarius, International Standard Organization (ISO), Food and Drug Administration (FDA), etc., and their regulations specifically for infant formula that can be adopted for complementary foods. This study focuses on the development of a hazard analysis and risk-based preventive controls (HARPC)-based food safety plan to ensure safe food processing and prevent any possible outbreaks.

19.
Zhongguo Zhong Yao Za Zhi ; 46(12): 2972-2983, 2021 Jun.
Article in Chinese | MEDLINE | ID: mdl-34467687

ABSTRACT

There have been many clinical trials, systematic reviews/Meta-analysis proving that Xingnaojing Injection has a good clinical efficacy in treatment of cerebral ischaemic stroke, but with fewer comprehensive descriptions. In this study, an overview of systematic reviews/Meta-analysis of Xingnaojing Injection in treating cerebral ischaemic stroke was performed to provide current situation of evidences and basis for clinical practice. CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science were retrieved through computers. A total of 6 literatures were included in this study. By AMSTAR-2 checklist and GRADE, the quality of included systematic reviews and the efficacy of Xingnaojing Injection were evaluated. The results of AMSTAR-2 checklist showed an extremely low quality for all of the 6 systematic reviews. According to the results of GRADE evaluation, among 55 outcomes, there were 2 outcomes with a medium quality, 4 outcomes with a low quality and 49 outcomes with an extremely low quality. The 6 systematic reviews reached a consistent conclusion that Xingnaojing Injection was effective in the treatment of cerebral ischaemic stroke. This therapy could improve the total efficacy, neurological deficit scores, hemodynamic and hemodynamic parameters. However, the methodolo-gical quality of all literatures was extremely low. The evidence levels of outcomes were between extremely low to medium. The effectiveness of Xingnaojing Injection in the treatment of cerebral ischaemic stroke still needs to be further verified by more high-quality studies. In the future, relevant clinical studies and systematic reviews/Meta-analysis shall be carried out in a strict accordance with relevant regulations.


Subject(s)
Brain Ischemia , Ischemic Stroke , Stroke , Brain Ischemia/drug therapy , Drugs, Chinese Herbal , Humans , Stroke/drug therapy , Systematic Reviews as Topic
20.
J AOAC Int ; 2021 Sep 20.
Article in English | MEDLINE | ID: mdl-34542627

ABSTRACT

BACKGROUND: Color additives requiring batch certification by the U.S. Food and Drug Administration (FDA) have Code of Federal Regulations (CFR) specification limits for certain elements and are usually analyzed by x-ray fluorescence spectrometry (XRF). However, sensitivity for Hg is too low in some color additives. OBJECTIVE: The thermal decomposition amalgamation-atomic absorption spectrometric (TDA-AAS) technique was investigated for providing quick and accurate determinations of Hg in certifiable color additives. METHODS: Tests were performed to optimize conditions and test reliability of Hg determinations at and below the CFR specification limit of 1 mg/kg. RESULTS: Sensitivity is much improved over XRF with limits of quantitation of 0.03 mg/kg for highly homogeneous color additives. CONCLUSIONS: The TDA-AAS method can be used for determining Hg concentrations at and below the CFR specification limit. The technique is effective for all color additives, including those that are difficult to analyze by XRF, but less efficient for color additives that quickly deteriorate the catalyst. Regular quality checks using certified reference materials and in-house matrix-matched check standards are essential. HIGHLIGHTS: The TDA-AAS method is applicable for use in routine color additive batch certification. Certain matrices (notably those that release nitrogen or sulfur oxides or halogens upon combustion) necessitate more frequent replacement of the catalyst and recalibration, impacting productivity. Color additives containing BaSO4, in color additive lakes, that are difficult to analyze by other techniques are well suited for TDA-AAS analysis.

SELECTION OF CITATIONS
SEARCH DETAIL
...