scholarly journals Research and Development of Novel Anti-thrombotic Agents. Investigational new drugs among glycoprotein IIb/IIIa-receptor antagonists.

2000 ◽  
Vol 116 (5) ◽  
pp. 263-268
Author(s):  
Kazunao KONDO
Keyword(s):  
Research And Development ◽  
New Drugs ◽  
Receptor Antagonists ◽  
Investigational New Drugs

Worldwide Regulatory Requirements and their Effects on the Clinical Study and Transport of Investigational New Drugs

1977 ◽  
Vol 11 (8) ◽  
pp. 470-476
Author(s):  
Bernard A. Haines
Keyword(s):  
Clinical Study ◽  
Research And Development ◽  
Clinical Utility ◽  
Pharmaceutical Products ◽  
Clinical Development ◽  
New Drugs ◽  
Regulatory Agencies ◽  
Regulatory Requirements ◽  
Clinical Drug ◽  
Investigational New Drugs

Worldwide politico-socioeconomic factors greatly influence the regulations and legislation that govern the clinical study of investigational new drugs. The increase in worldwide potential for pharmaceutical products, along with the escalating research and development expenditures, place an increased responsibility on R&D to produce new and improved products with worldwide clinical utility. Worldwide regulatory agencies play a significant role in the design and study of new drugs and in the transport of clinical drug supplies. The extent and influence of worldwide regulations on the clinical development of drugs for worldwide markets and on the transport of clinical drug supplies both now and in the future are presented.

Investigational new drugs for the treatment of acute coronary syndrome

2015 ◽  
Vol 24 (12) ◽  
pp. 1557-1570 ◽  
Author(s):  
Cormac T O’Connor ◽  
Thomas J Kiernan ◽  
Bryan P Yan
Keyword(s):  
Acute Coronary Syndrome ◽  
New Drugs ◽  
Coronary Syndrome ◽  
Investigational New Drugs

Studying the peculiarities of project and program management in the pharmaceutical companies on Russian market

2018 ◽  
Vol 7 (1) ◽  
pp. 19-33
Author(s):  
Екатерина Фролкина ◽  
Ekaterina Frolkina
Keyword(s):  
Life Cycle ◽  
Research And Development ◽  
Business Processes ◽  
Program Management ◽  
New Drugs ◽  
Pharmaceutical Companies ◽  
Development Projects ◽  
Russian Market ◽  
Key Features ◽  
A Company

The author singled out a typology of projects in pharmaceutical companies for the life cycle of the creation and commercializing of a new drug on the market, including research and development projects, production projects and implementation projects. In the framework of the study, the author examined only implementation projects, namely: projects for introducing new drugs to the market, projects to maintain existing drugs on the market and projects to optimize business processes. The purpose of this study was to identify key features of managing projects and programs in pharmaceutical companies operating on the Russian market, to form an approach to managing a company that increases its competitiveness.

scholarly journals Investigational new drugs for brain cancer

2016 ◽  
Vol 25 (8) ◽  
pp. 937-956 ◽  
Author(s):  
Verena Staedtke ◽  
Ren-Yuan Bai ◽  
John Laterra
Keyword(s):  
Brain Cancer ◽  
New Drugs ◽  
Investigational New Drugs

Investigational new drugs for the treatment of resistant pneumococcal infections

2005 ◽  
Vol 14 (8) ◽  
pp. 973-995 ◽  
Author(s):  
Holly L Hoffman-Roberts ◽  
Emily C Babcock ◽  
Isaac F Mitropoulos
Keyword(s):  
New Drugs ◽  
Pneumococcal Infections ◽  
Investigational New Drugs

scholarly journals Relationship between objective responses in phase I trialsand potential efficacy of non-specific cytotoxic investigational new drugs

2002 ◽  
Vol 13 (8) ◽  
pp. 1300-1306 ◽  
Author(s):  
I. Sekine ◽  
N. Yamamoto ◽  
H. Kunitoh ◽  
Y. Ohe ◽  
T. Tamura ◽  
...  
Keyword(s):  
Phase I ◽  
New Drugs ◽  
Potential Efficacy ◽  
Investigational New Drugs
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