Aspoxicillin: world first marketing approval for Tanabe Seiyaku's penicillin in Japan

InPharma ◽  
1987 ◽  
Vol 587 (1) ◽  
pp. 19-19
Keyword(s):  
Marketing Approval

scholarly journals Environmental fate and effects assessment of human pharmaceuticals: lessons learnt from regulatory data

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Simon Schwarz ◽  
Daniela Gildemeister ◽  
Arne Hein ◽  
Patrick Schröder ◽  
Jean Bachmann
Keyword(s):  
Environmental Fate ◽  
Environmental Risks ◽  
Marketing Approval ◽  
Current Guideline ◽  
The European Union ◽  
Medicinal Products ◽  
Effect Data ◽  
Assessment Approach ◽  
Biotic Degradation ◽  
High Sorption

AbstractHuman pharmaceuticals are extensively studied and assessed before marketing approval. Since 2006, this also includes an assessment of environmental risks. In the European Union, this is based on the guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2), which is currently under revision. For Germany, the German Environment Agency (UBA) is tasked with the evaluation of environmental risks of human pharmaceuticals. Applicants seeking approval of medicinal products need to submit fate and effect data, in case predicted environmental concentrations (PECs) exceed 10 ng/L in surface waters, or the substance is of specific concern through its mode of action or physico-chemical characteristics.Over the last decade, this regulatory work resulted in an internal agency database containing effect data on approximately 300 active pharmaceutical ingredients (APIs). A considerable part of this data is currently not publicly available due to property rights held by the respective applicants. The database was evaluated to draw conclusions on how the current assessment approach may be improved.The evaluation of aquatic effect data shows considerable variation in ecotoxic effect concentrations, but supports the current use of 10 ng/L as PEC action limit. For endocrine-active substances and antibiotics, a clear sensitivity profile was observed, which allows a more targeted assessment in the future. The conclusions drawn from terrestrial effect data are less clear, as the database itself is biased because information is only available for substances with high sorption. Further adaptations of the terrestrial assessment strategy, including action triggers, appear necessary. Fate data show a high persistence of many APIs: approximately 43% of all APIs are classified as very persistent; 12% of these show DT50 values in a range where abiotic or biotic degradation is not expected.Overall, the evaluation has shown that improvements of the current guideline are possible.

scholarly journals Marketing Approval of Ethical Kampo Medicines

2017 ◽  
Vol 137 (2) ◽  
pp. 163-165 ◽  
Author(s):  
Takashi Hakamatsuka
Keyword(s):  
Marketing Approval

scholarly journals Data Monitoring Committees: Current issues

2018 ◽  
Vol 15 (4) ◽  
pp. 321-328 ◽  
Author(s):  
Thomas R Fleming ◽  
Susan S Ellenberg ◽  
David L DeMets
Keyword(s):  
Best Practices ◽  
Safety Data ◽  
Data Monitoring Committee ◽  
Data Monitoring ◽  
Marketing Approval ◽  
Definitive Evidence ◽  
Trial Conduct ◽  
Risks And Benefits ◽  
Monitoring Committee ◽  
Study Participants

Maintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study participants and enhancing the integrity and credibility of clinical trials. Even with the wide recognition of these principles, there are circumstances where confidentiality issues remain challenging, controversial or inconsistently addressed. First, consider settings where a clinical trial’s interim data could provide the evidence regulatory authorities require for decisions about marketing approval, yet where such a trial would be continued post-approval to provide more definitive evidence about principal safety and/or efficacy outcomes. In such settings, data informative about the longer term objectives of the trial should remain confidential until pre-specified criteria for trial completion have been met. Second, for those other than Data Monitoring Committee members, access to safety and efficacy outcomes during trial conduct, even when presented as data pooled across treatment arms, should be on a limited “need to know” basis relating to the ability to carry out ethical or scientific responsibilities in the conduct of the trial. Third, Data Monitoring Committee members should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits. Fourth, it should be recognized that a mediator potentially could be useful in rare settings where the Data Monitoring Committee would have serious ethical or scientific concerns about the sponsor’s dissemination or lack of dissemination of information. Data Monitoring Committee Contract Agreements, Indemnification Agreements and Charters should be developed in a manner to protect Data Monitoring Committee members and their independence, in order to enhance the Data Monitoring Committee’s ability to effectively address their mission.

State of the art in the production of transgenic goats

2004 ◽  
Vol 16 (4) ◽  
pp. 465 ◽  
Author(s):  
H. Baldassarre ◽  
B. Wang ◽  
C. L. Keefer ◽  
A. Lazaris ◽  
C. N. Karatzas
Keyword(s):  
Recombinant Proteins ◽  
Traditional Method ◽  
Nuclear Transfer ◽  
State Of The Art ◽  
Expression Vectors ◽  
Marketing Approval ◽  
Transfected Cells ◽  
Pronuclear Microinjection ◽  
Transgenic Goats

This review summarises recent advances in the field of transgenic goats for the purpose of producing recombinant proteins in their milk. Production of transgenic goats via pronuclear microinjection of DNA expression vectors has been the traditional method, but this results in low efficiencies. Somatic cell nuclear transfer has dramatically improved efficiencies in rates of transgenesis. Characterisation of transfected cells in vitro before use in nuclear transfer guarantees that kids born are transgenic and of predetermined gender. Using these platform technologies, several recombinant proteins of commercial interest have been produced, although none of them has yet gained marketing approval. Before these technologies are implemented in goat improvement programmes, efficiencies must be improved, costs reduced, and regulatory approval obtained for the marketing of food products derived from such animals.

Evaluation of Orphan Products by the U.S. Food and Drug Administration

1992 ◽  
Vol 8 (4) ◽  
pp. 647-657 ◽  
Author(s):  
Marlene E. Haffner ◽  
John V. Kelsey
Keyword(s):  
Drug Administration ◽  
Rare Diseases ◽  
Food And Drug Administration ◽  
Orphan Drugs ◽  
Marketing Approval ◽  
Drug Products ◽  
Governmental Agencies ◽  
Number Of Patients ◽  
Life Threatening ◽  
The U.S

AbstractOrphan drug products generally are used in treating or preventing rare diseases. The small number of patients available for study may create special problems in the evaluation of these products. This paper examines some of the special problems that are associated with the design and implementation of studies to evaluate the safety and efficacy of orphan drugs. The U.S. Food and Drug Administration (FDA) has not established special criteria for evaluating orphan drugs per se, but the FDA has been flexible in evaluating drug products that present special problems, especially when these products are for treatment of serious of life-threatening illnesses. The FDA and other U.S. governmental agencies also have taken steps to promote the development and availability of drugs for rare diseases, including making these products available to patients who are in need, even before the drugs have full FDA marketing approval.

scholarly journals Lessons From the Development of the Immune Checkpoint Inhibitors in Oncology

2018 ◽  
Vol 17 (4) ◽  
pp. 1012-1015 ◽  
Author(s):  
Denis L. Jardim ◽  
Débora de Melo Gagliato ◽  
Razelle Kurzrock
Keyword(s):  
Phase I ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Dose Finding ◽  
Priority Review ◽  
Marketing Approval ◽  
Phase I Trials ◽  
Clinical Cancer Research ◽  
Number Of Patients

Immunotherapies are becoming increasingly important in the treatment armamentarium of a variety of malignancies. Immune checkpoint inhibitors are the most representative drugs receiving regulatory approval over the past few years. In a recent study published in Clinical Cancer Research, we demonstrated that these agents are being developed faster than other prior anticancer therapies. All checkpoint inhibitors received priority review, being granted with at least one Food and Drug Administration expedited program. Hence, some of them are getting marketing approval after preliminary trials. The model continues to rely on phase I trials, designed with traditional models for dose definition, although a substantial number of patients are treated during the dose expansion cohorts. We demonstrated that efficacy and safety are reasonably predicted from the dose-finding portion of phase I trials with these agents, assuring a low treatment-related mortality for patients throughout the development process. In this article, we further discuss and summarize these findings and update some recent approval information for immune checkpoint inhibitors.

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