United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America / Autorización de la Administración de Alimentos y Medicamentos de Estados Unidos de declaraciones sobre exposición reducida respecto de IQOS: implicaciones para la regulación en América Latina / Autorização pela Administração de Alimentos e Fármacos dos Estados Unidos de alegações de exposição reduzida para os produtos IQOS: implicações para a regulamentação na América Latina

ABSTRACT Philip Morris International has used the July 7, 2020 United States Food and Drug Administration's (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing claims, as a corporate strategy to promote and normalize its heated tobacco products in Latin America. The modified risk tobacco product orders are based on the US's unique regulatory system that is not, and should not be, replicated anywhere else in the world. Philip Morris International's global public relations campaign largely ignored the FDA's rejection of reduced risk claims for IQOS and other key FDA findings that are important for policy-makers, regulators, and consumers - including tobacco users and Philip Morris International's customers - to understand the risks associated with the product. In Latin America in particular, Philip Morris International has used media outlets to promote this misleading information to the public. This company has also used the FDA ruling to lobby regulators in Latin America to relax regulations on IQOS in the region. As tobacco companies rapidly introduce new tobacco products in low- and middle-income countries, public health advocates and Parties to the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) should take measures to prevent the promotion of misleading statements about heated tobacco products, including IQOS. As Latin American countries are at different stages in their regulation of heated tobacco products, governments should adhere to their WHO FCTC obligations and the recommendations of the Conference of the Parties by entirely prohibiting the sale of heated tobacco products or strictly applying to heated tobacco products all the relevant tobacco demand-reduction policies based on the WHO FCTC (making sure to capture both heated cigarettes and heating devices).

RESUMEN Philip Morris International ha empleado el dictamen que la Administración de Alimentos y Medicamentos (FDA) de Estados Unidos emitió el 7 de julio del 2020 sobre IQOS como producto de tabaco de riesgo modificado —que la autorizó a usar ciertas declaraciones relativas a una exposición reducida al comercializar el producto— como estrategia corporativa para promover y normalizar sus productos de tabaco calentado en América Latina. Los dictámenes sobre productos de tabaco de riesgo modificado se fundamentan en el sistema regulatorio único de Estados Unidos, que no se replica ni debería ser replicado en ningún otro lugar del mundo. La campaña mundial de relaciones públicas de Philip Morris International omitió en gran medida que la FDA rechazó los argumentos de que IQOS implica un riesgo reducido y otros hallazgos clave de la FDA que son importantes para que los responsables de las políticas, los reguladores y los consumidores, incluidos los consumidores de tabaco y los clientes de Philip Morris International, comprendan los riesgos asociados con el producto. En América Latina en particular, Philip Morris International ha utilizado los medios de comunicación para difundir esta información engañosa. Esta compañía también ha utilizado el fallo de la FDA para presionar a los reguladores en América Latina con el objetivo de que flexibilicen las regulaciones sobre IQOS en la Región. A medida que las compañías tabacaleras introducen con celeridad nuevos productos de tabaco en países de ingresos bajos y medianos, los defensores de la salud pública y los Estados Parte del Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud (CMCT de la OMS) deben tomar medidas para evitar la difusión de declaraciones engañosas sobre los productos de tabaco calentado, como IQOS. Dado que los países latinoamericanos se encuentran en diferentes etapas en la regulación de los productos de tabaco calentado, los gobiernos deben cumplir con sus obligaciones estipuladas en el CMCT de la OMS y las recomendaciones de la Conferencia de las Partes mediante la prohibición total de la venta de productos de tabaco calentado o la aplicación estricta a los productos de tabaco calentado de todas las políticas pertinentes sobre la reducción de la demanda de tabaco basadas en el CMCT de la OMS (y asegurarse de abarcar tanto los cigarrillos calentados como los dispositivos de calentamiento).

RESUMO A Philip Morris International utilizou a decisão de 7 de julho de 2020 da Administração de Alimentos e Fármacos dos Estados Unidos (United States Food and Drug Administration, FDA), que caracterizou o IQOS como produto de tabaco com risco modificado e que permitiu o uso de determinadas alegações de exposição reduzida no marketing do produto, como estratégia corporativa para promover e normalizar seus produtos de tabaco aquecido na América Latina. As decisões relativas aos produtos de tabaco com risco modificado se baseiam no singular sistema regulatório dos EUA, que não é e não deve ser reproduzido em nenhum outro lugar do mundo. A campanha global de relações públicas da Philip Morris International ignorou em grande parte a rejeição da FDA às afirmações de risco reduzido do IQOS e outros achados fundamentais da FDA, que são informações importantes para formuladores de políticas, órgãos regulamentadores e consumidores - incluindo usuários de tabaco e clientes da Philip Morris International - entenderem os riscos associados ao produto. A Philip Morris International tem usado a mídia para veicular essa informação enganosa ao público, principalmente na América Latina. A empresa também usou a decisão da FDA para pressionar órgãos regulamentadores na América Latina a flexibilizarem a regulamentação do IQOS na região. Conforme as empresas de tabaco introduzem rapidamente novos produtos em países de baixa e média renda, os ativistas de saúde pública e as Partes da Convenção-Quadro para Controle do Tabaco (CQCT) da Organização Mundial da Saúde (OMS) devem tomar providências para prevenir a promoção de alegações enganosas sobre produtos de tabaco aquecido, incluindo o IQOS. Como os países da América Latina estão em diferentes estágios da regulamentação de produtos de tabaco aquecido, os governos devem cumprir suas obrigações com a CQCT da OMS e seguir as recomendações da Conferência das Partes, proibindo totalmente a venda de produtos de tabaco aquecido ou aplicando rigorosamente aos produtos de tabaco aquecido todas as políticas relevantes de redução da demanda por tabaco, com base na CQCT da OMS (certificando-se de abranger tanto os cigarros aquecidos quanto os dispositivos de aquecimento).

Updated key points of chronic hepatitis B virus infection: developing drugs for treatment issued by the U.S. food and drug administration(clinical part) / 临床肝胆病杂志

In November 2018, the U.S. food and drug administration (FDA) issued guidance for the development of drugs for chronic hepatitis B virus infection (draft for comments) (hereinafter referred to as draft for comments), and in April 2022, the FDA issued Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, which has been updated with some details based on the Draft for Comments. This guidance further emphasizes the importance of HBsAg clearance in clinical trials, and classifies chronic suppressive therapy into two categories, namely noninferiority (NI) (or superiority) test with nucleos(t)ide analogues as control and add-on superiority trial with nucleos(t)ide analogues as control, and as for the latter, HBV DNA is no longer recommended as a primary endpoint of the trial, which poses a huge challenge to the development of innovative drugs targeting HBV DNA. The new finite duration therapy should aim to eliminate HBsAg and reduce virologic relapse and the risk of liver disease progression during treatment cessation. Reduction in HBsAg from baseline is not recommended as a primary endpoint for phase Ⅲ clinical trials, since the correlation between such reduction and clinical response remains unclear. In addition, this guidance also specifies the duration of treatment cessation and treatment consolidation period and the criteria for withdrawal of nucleos(t)ide analogues.

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries / Utilización de decisiones de autoridades regulatorias de otras jurisdicciones para aprobar nuevos productos medicinales en países de América Latina y el Caribe / Uso de decisões regulatórias de outras jurisdições para aprovação de novas especialidades farmacêuticas em países da América Latina e Caribe

ABSTRACT Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on. Methods. Websites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the reference (trusted) regulators defined as such by the corresponding national legislation. Results. Regulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators. Conclusions. Regulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.

RESUMEN Objetivo. Describir el estado actual de la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones en América Latina y el Caribe mediante la evaluación de los marcos regulatorios nacionales para la aprobación de nuevos medicamentos y establecer los organismos regulatorios extranjeros que se consideran autoridades regulatorias confiables para cada país. Métodos. Se realizaron búsquedas en los sitios web de las autoridades regulatorias de América Latina y el Caribe para identificar las regulaciones oficiales para la aprobación de nuevos medicamentos. La recopilación de datos se llevó a cabo en diciembre del 2019 y se completó en junio del 2020 para los países del Caribe. Dos equipos independientes recopilaron información sobre el reconocimiento directo o los procedimientos abreviados para la aprobación de nuevos medicamentos y los autoridades regulatorias de referencia (confiables) así definidos en la legislación nacional correspondiente. Resultados. Se encontraron documentos regulatorios sobre la aprobación de nuevos productos en los sitios web de veinte organismos regulatorios de América Latina y el Caribe, que abarcaban 34 países. Siete países no aceptan la utilización de decisiones de autoridades regulatorias extranjeras. Trece autoridades regulatorias (Argentina, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, México, Panamá, Paraguay, Perú, República Dominicana, Uruguay y el sistema regulador único para quince Estados del Caribe) aceptan de manera explícita confiar las decisiones para aprobación de nuevos medicamentos emitidas por la Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá. Diez países aceptan también utilizar las autorizaciones para la comercialización de Australia, Japón y Suiza. Argentina, Brasil, Chile y México son autoridades de referencia para ocho autoridades regulatorias en la región. Conclusiones. La utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se han convertido en una práctica común en América Latina y el Caribe. Trece de veinte autoridades regulatorias reconocen directamente o abrevian el proceso de aprobación de nuevos medicamentos en caso de que hayan recibido previamente la aprobación por parte de un organismo regulatorio de otra jurisdicción. La Agencia Europea de Medicamentos, la Administración de Alimentos y Medicamentos de Estados Unidos y Salud Canadá son las autoridades regulatorias de otras jurisdicciones en las cuales los reguladores de América Latina y el Caribe confían más.

RESUMO Objetivo. Descrever a prática atual de uso de decisões regulatórias de outras jurisdições na América Latina e no Caribe (ALC) mediante avaliação os marcos regulatórios dos países para aprovação de novos medicamentos e verificar, para cada país, quais entidades reguladoras estrangeiras são consideradas autoridades reguladoras de confiança por cada país. Métodos. Foi realizada uma pesquisa nos sites das autoridades reguladoras da ALC para identificar as regulamentações oficiais para aprovação de novos medicamentos. A coleta de dados foi feita em dezembro de 2019 e concluída em junho de 2020 para os países do Caribe. Dois grupos independentes coletaram informações sobre o reconhecimento direto ou o procedimento abreviado para aprovação de novos medicamentos e as autoridades reguladoras de referência (de confiança) definidas como tal pela respectiva legislação nacional. Resultados. Documentos regulatórios relacionados à aprovação de novos produtos foram obtidos de 20 sites de órgãos reguladores da ALC, abrangendo 34 países. Sete países não admitem o uso de decisões regulatórias de entidades reguladoras externas. Treze autoridades reguladoras (na Argentina, Colômbia, Costa Rica, El Salvador, Equador, Guatemala, México, Panamá, Paraguai, Peru, República Dominicana, Uruguai e o Sistema Regulador do Caribe unificado para 15 Estados caribenhos) admitem explicitamente a admissibilidade de decisões regulatórias para aprovação de novos medicamentos de outras jurisdições, quais sejam: Agência Europeia de Medicamentos (EMA), Agência Reguladora de Alimentos e Medicamentos (FDA) dos EUA e Health Canada. Dez países também aceitam decisões para autorização de comercialização da Austrália, Japão e Suíça. Argentina, Brasil, Chile e México são autoridades de referência para oito agências reguladoras. Conclusões. O uso de decisões regulatórias de outras jurisdições tornou-se prática comum na América Latina e Caribe. Treze das 20 agências reguladoras reconhecem diretamente ou abreviam o procedimento de aprovação de novos medicamentos no caso de tal aprovação já haver sido concedida por uma autoridade reguladora de outra jurisdição. A EMA, a FDA e a Health Canada são as autoridades estrangeiras nas quais as agências reguladoras da América Latina e Caribe mais confiam.

Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts / 中国中药杂志

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.

‘Testosterone Boosting’ Supplements Composition and Claims Are not Supported by the Academic Literature

FDA guidelines for preclinical evaluation of radiopharmaceuticals / 中华核医学与分子影像杂志

Preclinical evaluation is related to the clinical safety of radiopharmaceuticals.There are different research foci on preclinical evaluation of different radiopharmaceuticals.This article summarizes the Food and Drug Administration (FDA) preclinical evaluation guidelines of diagnostic and therapeutic radiopharmaceuticals,in order to provide reference for domestic research and preclinical evaluation of radiopharmaceuticals.

Introduction of radiopharmaceutical administration policy of FDA / 中华核医学与分子影像杂志

Radiopharmaceuticals have been widely used in the diagnosis, treatment and monitoring of diseases, and they play an important role in new drug development. Food and Drug Administration(FDA) has rich experience in the administration of radiopharmaceuticals. This article mainly interprets the regulato-ry policy of FDA for radiopharmaceuticals from the aspects of definition, regulations and registration, trying to provide reference for domestic research of radiopharmaceuticals.

Statistical Analysis of Administrative Reconsideration in Food and Drug Administration During 12nd Five-Year Plan / 中国药学杂志

OBJECTIVE: To analyze the capacity of food and drug regulatory system through detailed data analysis in administrative reconsideration (AR), and provide strategy to enhance the food and drug regulatory system. METHODS: Data are derived from the Annual Statistical Report of China Food and Drug Administration during the 12nd Five-Year Plan period, and the laws and rules in AR, including Provisions for Administrative Reconsideration of China Food and Drug Administration, Implementation Advice on Comprehensive Strengthening the Legal System in Food and Drug Regulatory System. Numbers, categories and geographical areas are considered. RESULTS AND CONCLUSION: During the given period, the number of acceptance in AR in food and drug administration increased from 104 to 4 331. Food related AR hits the top in 6 343 accounted for 78.5% AR number shows significant regional differences, Guangdong is 2 045 on the top, Xinjiang and Tibet only have one. More than 4 500 AR are concluded, within which 1 007 are rejected, 2 480 original administrative enforcement were maintained. It can be concluded that the number of AR in China food and drug regulatory system has increased significantly, the workload in food and drug regulatory system is arduous, the work force and capacity in legal system at grassroots level food and drug administration are relatively insufficient. It shows economic activity relevant in the number of AR.AR promotes normative law enforcement. It is suggested to strengthen the legal power team, improve legal literacy of staff and enhance performance evaluation in law based enforcement.

Development trend of Chinese materia medica products in China: An analysis of CFDA-approved Chinese materia medica (2011-2015) / 中草药

To explore the innovation trend of Chinese materia medica (CMM) and provide reference for domestic research and development workers, we sorted out the drugs of CMM approved by China Food and Drug Administration (CFDA) during 2011-2015 through database retrieval, analyzed their drug categories, components, dosage forms, and therapeutic areas, and there were 176 approved CMM registration applications. Among all the 176 approved CMM registration applications, only two approved in class 3, and class 5 has 10, class 6 has 42, and others are three additional CMM categories of class 7-9. There are more compound preparations than on single preparations, and components focus on several key herbs such as Bupleurum and Salvia. Nine dosage forms are mostly focus on capsules and tablets. Therapeutic areas are focus on diseases of genitourinary system and circulatory system. It concludes that innovation of CMM needs to combine CMM theory, learn from modern research and development production technology, and focus on the urogenital system and other areas of increasing demand, and CFDA should also improve the efficiency of the review.

Analysis of FDA's Review for NDA208542-Rociletinib / 世界科学技术-中医药现代化

Lung cancer is the highest mortality rate of malignancies in the world.Among them,non-small cell lung cancer (NSCLC) accounts for 85％.Epidermal growth factor receptor (EGFR) gene is one of the most common driving genes in NSCLC.The EGFR tyrosine kinase inhibitors (EGFR-TKIs) bring a breakthrough in the treatment for patients with EGFR gene-sensitive mutations.However,the drug resistance problem of EGFR-TKIs has been increasingly highlighted.So a drug for the patients accompanied by EGFR T790M positive mutation and along with progression in or after treatment with EGFR-TKI NSCLC is clinically urgent needed.Rociletinib is designed to address this unmet clinical need.While considering the non-superior effectiveness to the similar drugs in the market and the high risk of safety (hyperglycemia,QT prolongation and sudden death) of Rociletinib,the dosage was not accepted by the Food and Drug Administration (FDA).And Rociletinib did not make it to the market eventually.This paper discussed lessons learned from this case under review perspective for reference and inspiration.

Developmental and Regulatory History of Food and Drug Administration / 世界科学技术-中医药现代化

TThe USA Food and Drug Administration (FDA) has an over 100-year history and is the most authority drug administration.During its past records,the most important thing for FDA is facing law enforcement challenges.However,FDA insists on improving legislation and finding the perfect mode of regulation.This paper introduced the history evolution,regulatory course,present office structure of FDA,Center for Drug Evaluation and Research (CDER),and Center for Biologics Evaluation and Research (CBER).The frustration and experience for FDA is well discussed.The legislation system is interpreted through historical events.To learn the developmental and regulatory history of USA food and drug administration is important to our drug administration for practicing the mission of protecting and promoting public health.

Ten years after the FDA black box warning for antidepressant drugs: a critical narrative review

ABSTRACT Background The United States Food and Drug Administration (FDA) has warned about the increased suicidality risk associated with the use of selective serotonin reuptake inhibitors (SSRI) and venlafaxine in children and adolescents. Objectives To critically appraise the available evidence supporting the FDA Black box warning concerning to the use of antidepressants in child and adolescents. Methods A critical review of articles in Medline/PubMed and SciELO databases regarding the FDA Black box warning for antidepressants, and the impact of FDA warnings on antidepressant prescriptions and suicide rates. Results The warning was based on surveys that did not report either cases of suicide nor a significant difference supporting an increased suicidality rate. The concept was defined in an ambiguous way and there is currently more available evidence to support such definition. The use of SSRI and venlafaxine has been associated to lower suicidality rates, but the prescription fall due to the warning increased suicide rates. Discussion Suicidality is an inherent feature of depressive disorders so it would be desirable to consider how much of the phenomenon may be attributed to antidepressants per se. It would be appropriate to consider that suicide rates might increase also as a consequence of the warning.

Study on the construction of food and drug safety emergency drill and training program / 中国药学杂志

OBJECTIVE: The emergency practice and training program of food and drug safety in China's food and drug administration system is studied. METHODS: The relevant situation of food and drug safety emergency drills and training in European Union and the emergency drills and training of food and drug in our country are learned. RESULTS: The food and drug emergency drills and training programs in our country is explored and prospected, and the related thinking and enlightenment is put forward. CONCLUSION: The food and drug safety emergency drills and training, innovation the exercise form and the content of the exercise should be vigorously strengthened, a hierarchical field emergency drill mechanism, prominent combat emergency drills will be established, and pay attention to emergency response drill assessment.

Evaluation of Dermatological Disorders Caused by Anti-neoplastic Agents with an Adverse Event Spontaneous Reporting Database / 医薬品情報学

<b>Introduction</b>: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents.  The severe symptoms associated with these disorders affect the patients’ quality of life (QOL).  Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.<br><b>Materials and Methods: </b>We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports.  In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis.  Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.<br><b>Results: </b>After excluding duplicate data in FAERS, 6,157,897 reports were analyzed.  The number of reports that showed a dermatological disorder was 534,934.  The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.<br><b>Conclusions: </b>We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high.  Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features.  Further studies are required to draw conclusions over these findings.  Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.

The fate of medications evaluated for ischemic stroke pharmacotherapy over the period 1995-2015

Stroke is a brain damage caused by a loss of blood supply to a portion of the brain, which requires prompt and effective treatment. The current pharmacotherapy for ischemic stroke primarily relies on thrombolysis using recombinant tissue plasminogen activators (rt-PAs) to breakdown blood clots. Neuroprotective agents that inhibit excitatory neurotransmitters are also used to treat ischemic stroke but have failed to translate into clinical benefits. This poses a major challenge in biomedical research to understand what causes the progressive brain cell death after stroke and how to develop an effective pharmacotherapy for stroke. This brief review analyzes the fate of about 430 potentially useful stroke medications over the period 1995-2015 and describes in detail those that successfully reached the market. Hopefully, the information from this analysis will shed light on how future stroke research can improve stroke drug discovery.

Case analysis and inspiration on a case of American dietary supplements management / 国际中医中药杂志

Oregon sued a certain American well-known supplements’agency contained illegal ingredients on Oct.22, 2015. The event presented that FDA showed the problem of the management issues on the supplement ingredients. This event also triggered the discussions about the role of supervisation and law enforcement of FDA and State government. This paper aimed to systematically analyze the related problems in such issue and tried to offer suggestion of food regulation and ingredient management to the researchers and administrators in China.

Flavonoid profiling of a traditional Chinese medicine formula of Huangqin Tang using high performance liquid chromatography

The quality control processes for herbal medicines have been problematic. Flavonoids are the major active components of Huangqin Tang (HQT, a traditional Chinese medicine formula). In this study, we used a combinative method approach consisting of chromatographic fingerprinting (high performance liquid chromatography; HPLC), quantitative methods and a pharmacodynamic evaluation model to analyze the flavonoids of HQT obtained from different sources. Ten batches of HQT were analyzed by the HPLC fingerprinting method and 26 common peaks were detected, of which 23 peaks corresponded with the chemical profile of HQT. In addition, 11 major compounds were identified by LC-MS analysis (liquid chromatography-tandem mass spectrometer; LC-MS (n) ) and quantified by the HPLC quantitative method approach. The studied 10 batches of HQT were found to be homogeneous in their composition with a similarity between 0.990 and 1.000. The distribution of the 11 identified compounds was found to be very similar among the batches. Only slight pharmacodynamic differences were detected between the different batches, confirming the homogeneity of HQT. The results of this study prove that the combination of chromatographic fingerprinting and quantitative analysis can be readily used for comprehensive quality control of herbal medicines.

Sodium-glucose co-transporter-2 inhibitors as anti-diabetic agents: a review.

The incidence and prevalence of Type 2 diabetes mellitus (T2DM) have been increasing worldwide. However, existing therapeutic classes of anti-diabetic drugs are not adequately effective in achieving and maintaining long-term glycemic control in the most patients. The majority of the drugs control blood sugar without addressing the basic pathology of insulin resistance and relative defi ciency. Moreover, side effects such as hypoglycemia and weight gain, of both new and established drugs need to be considered prior to treating a patient. An emerging anti-hyperglycemic intervention, the sodium glucose co-transporter 2 (SGLT2) inhibitor acts by a novel mechanism. Under physiological conditions, SGLT2 accounts for 90% of the glucose re-absorption in the kidney, while the SGLT2 inhibitors result in an increase in urinary excretion of glucose and lower plasma glucose levels. Here, the pros and cons of SGLT2 inhibitors are considered, while approaching a patient with T2DM. The basic biochemistry and physiology underlying the mechanisms of SGLT2 inhibitors are discussed alongside its clinical pharmacology, with a focus on metabolic changes associated with urinary glucose loss. Finally, a consideration of Food and Drug Administration safety concerns associated with acidosis due to SGLT2 inhibitor usage is presented, to allow a complete understanding of the utility of these molecules in the light of existing T2DM therapies.

Bipolar disorder: a review of current U.S. Food and Drug Administration approved pharmacotherapy.

Bipolar disorder (BD) is a chronic disorder which usually has its onset in early adulthood. At one end of the spectrum is depression and at other is mania. Like many psychiatric illnesses, it is not treatable but its symptoms are completely manageable with medications. Commonly used drugs are mood stabilizers and atypical antipsychotics along with adjunctive medications such as anxiolytics and antidepressants. In general, a combination of these drugs is used for treatment. These drugs have significant adverse effects which add to the burden of the disease. Presently, there are 11 US Food and Drug Administration - approved drugs for management of acute mania, 3 for bipolar depression and 7 for bipolar maintenance. This review article details the use of these drugs in BD.

Development of therapeutic biologics from 1984 to 2014 / 中国药理学通报

This article is to analyse the development of therapeu-tic biologics from 1984 to 2014. Data were obtained from the Drugs @ FDA, PubMed, Embase. com and ClinicalTrail. Gov. Descriptive analyses were used to classify therapeutic biologics by level of innovation,therapeutic category and the chemical na-ture of the drugs. The results showed that from 1996 the thera-peutic biologics entered the fast development period, especially from 2001 to 2005. The 125 therapeutic biologics focus on the treatment of tumor, immune system disease, endocrine and met-abolic diseases, blood system diseases, skeletal muscle system diseases. Antibody has become the dominant of therapeutic bio-logics. Antibody is widely used in the treatment of cancer, di-gestive diseases, immune diseases, respiratory diseases, urinary diseases, skeletal muscle diseases, etc.