Overviews and analysis of the U.S. FDA′s new approvals in the 2016 second half year / 国际药学研究杂志

In the second half of 2016,the U.S. Food and Drug Administration(FDA)approved 7 new molecular entities and 3 new Biologic License Application(BLA), the lowest number in recent years. According to the prescription information for profes-sionals,this article introduced the description,mechanism of action and clinical studies and briefly describes the boxed warning,indi-cations and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reac-tions,drug interaction and the use in the special population. In addition,the first and critical events in the history of new drug develop-ment and reaserch were emphasized.

Historical Origins of the Tuskegee Experiment: The Dilemma of Public Health in the United States / 의사학

The Tuskegee Study of Untreated Syphilis in the Negro Male was an observational study on African-American males in Tuskegee, Alabama between 1932 and 1972. The U. S. Public Health Service ran this study on more than 300 people without notifying the participants about their disease nor treating them even after the introduction of penicillin. The study included recording the progress of disease and performing an autopsy on the deaths. This paper explores historical backgrounds enabled this infamous study, and discusses three driving forces behind the Tuskegee Study. First, it is important to understand that the Public Health Service was established in the U. S. Surgeon General's office and was operated as a military organization. Amidst the development of an imperial agenda of the U.S. in the late 19th and early 20th centuries, the PHS was responsible for protecting hygiene and the superiority of “the American race” against infectious foreign elements from the borders. The U.S. Army's experience of medical experiments in colonies and abroad was imported back to the country and formed a crucial part of the attitude and philosophy on public health. Secondly, the growing influence of eugenics and racial pathology at the time reinforced discriminative views on minorities. Progressivism was realized in the form of domestic reform and imperial pursuit at the same time. Major medical journals argued that blacks were inclined to have certain defects, especially sexually transmitted diseases like syphilis, because of their prodigal behavior and lack of hygiene. This kind of racial ideas were shared by the PHS officials who were in charge of the Tuskegee Study. Lastly, the PHS officials believed in continuing the experiment regardless of various social changes. They considered that black participants were not only poor but also ignorant of and even unwilling to undergo the treatment. When the exposure of the experiment led to the Senate investigation in 1973, the participating doctors of the PHS maintained that their study offered valuable contribution to the medical research. This paper argues that the combination of the efficiency of military medicine, progressive and imperial racial ideology, and discrimination on African-Americans resulted in the Tuskegee Syphilis Experiment.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015,the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti?ties single or compounds and 15 biologics license applications,a total of 35 which record number of approved innovative drugs. Ac?cording to the prescription information for professionals,this article briefly describes the description,mechanism of action and clinical studies,the box warning,indications and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and criti?cal events in the history of new drug development and reaserch are emphasized.

New drugs approved by the U.S. FDA(2007-2016):a review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“Journal of International Pharmaceutical Research”for ten years. However,new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated,such as the indications and purposes change,supplement of the modified efficacy,clinical data and the important new indications,constant improvement of the dosage,form and mode of administration,and the emergence of new,seri?ous and even fatal adverse reactions urge the supplements of contraindications,warnings and precautions,or even the black box warn?ings. In brief,6 entries of the introductions all may be modified,supplemented or canceled. More importantly,ten years of general analyses also find some prominent events,such as the amount of new molecular entity(NME)and new biological products come to an obvious peak in 2015. With regard to this,this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Overviews and analysis of the U.S. FDA′s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016,the U.S. food and drug administration(FDA)approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals,this article introduces the description, mechanism of action and clinical studies;briefly describes the box warning,indications and usage,dosage and administration,dos?age form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and critical events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in the 2015 second half year / 国际药学研究杂志

In the second half year of 2015, the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti-ties single or compounds and 15 biologics license applications, a total of 35 which record number of approved innovative drugs. Ac-cording to the prescription information for professionals, this article briefly describes the description, mechanism of action and clinical studies, the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and criti-cal events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA’ s new approvals in the first half year of 2016 / 国际药学研究杂志

In the first half year of 2016, the U.S. food and drug administration (FDA) approved 9 new molecular entities and 8 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

New drugs approved by the U.S. FDA (2007-2016): A review / 国际药学研究杂志

The introductions of the new drugs approved by the U.S. FDA have been published in the“ Journal of International Pharmaceutical Research ”for ten years. However, new problems might emerge with the increasing clinical practice and the cumulative number of patients being treated, such as the indications and purposes change, supplement of the modified efficacy, clinical data and the important new indications, constant improvement of the dosage, form and mode of administration, and the emergence of new, serious and even fatal adverse reactions urge the supplements of contraindications, warnings and precautions, or even the black box warnings. In brief, 6 entries of the introductions all may be modified, supplemented or canceled. More importantly, ten years of general analyses also find some prominent events, such as the amount of new molecular entity (NME)and new biological products come to an obvious peak in 2015. With regard to this, this paper reviewed the prominent historical events happened in the ten years in order to provide guidance and reference for new drug research and development.

Overviews and analysis of the U.S. FDA′s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration(FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overviews and analysis of the U.S. FDA’s new approvals in first half year of 2015 / 国际药学研究杂志

In the first half year of 2015, the U.S. Food and Drug Administration (FDA) approved 11 new molecular entities and 5 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug reaserch and development are emphasized.

Overview and analysis of the U.S. FDA′s new approvals in the second half year of 2014 / 国际药学研究杂志

In the second half year of 2014, the U.S. Food and Drug Administration (FDA) approved 72 new drugs, including 18 new molecular entities (NME) and 10 new biologic license application. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies; briefly describes the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the first and critical events in the history of new drug development and reaserch are emphasized.

Overviews and analysis of the U.S. FDA′s new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.

Overviews and analysis of the U.S. FDA's new approvals in 2014 first half year / 国际药学研究杂志

In the first half of 2014, the U.S. Food and Drug Administration (FDA) approved 46 new drugs, including 10 new molecular entities and 10 new biologic license applications. According to the prescription information for professionals, this article introduces the description, mechanism of action and clinical studies, briefly describs the box warning, indications and usage, dosage and administration, dosage form and strength, contraindications, warning and precautions, adverse reactions, drug interaction and use in special population of these new drugs. In addition, the “first events” in the history of new drug research, development and approval are also discussed.

Overviews and analysis to the U. S. FDA's new approvals in 2012 / 国际药学研究杂志

In 2012, the U. S. Food and Drug Administration (FDA) approved 34 new drugs, including 23 new molecular enities and 11 new biological products. According to he prescription nformation for professionals, this article briefly describes he description, mechanism of action, the box warning, indications and usage, dosage and administration, dosage form and strength, contrandications, warning and precautions, adverse reactions, drug nteraction and use of these new drugs n special population. In addiion, the first events n he history of new drug research, development and approval are also discussed.

Introduction and analysis to the U.S. FDA's new drug approvals in 2010 / 国际药学研究杂志

In 2010, the U.S. FDA totally approved 24 new drugs, including 11 new molecular entities, 10 new biological products and 3 new vaccines. According to the prescribing information of drug specifications, this article outlines the properties, chemical name and structure, action of mechanism, manufacturer, indication, dosage and usage, contraindications, adverse reactions, boxed warning and other relevant informations of them. In addition, the "first events" in the history of new drug research and development in 2010 are also summarized, and the overview of the new drugs approval by FDA from the years of 2008 to 2010 is also analyzed.

On Social Participation and Reference of American Higher Education Management System / 中华医学教育探索杂志

This article analyzed the type,the significance,the role and the origin of the social participation of American higher education management,which is expected to play to the certain degree model function for the establishment of Chinese modem university system.

Report on my Experience during of the Summer Semester of an American Nursing School / 医学教育

I took a summer course at the School of Nursing of the University of Delaware in the United States. The 4-week neurology and neurosurgery course had been organized by a clinical nurse specialist. The curriculum was extremely effective because one clinical topic was taught for a certain period of time. This system has been judged to be useful for teaching clinical nursing. A similar program might also be useful for nursing schools in Japan.