Overhauling clinical trials

Article Abstract:

The European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have issued guidelines on the new types of clinical trial techniques that are referred to as flexible or adaptive. The advantages and limitations of these adaptive clinical trials are discussed and compared with the randomized controlled trials, which are used for more than half a century.

Author: Baker, Monya, Scott, Christopher Thomas
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2007
Europe, Legal issues & crime, Government regulation (cont), Government regulation, Management dynamics, Legal/Government Regulation, Methods, Management, Laws, regulations and rules, Clinical trials, Company business management, United States. Food and Drug Administration, European Agency for the Evaluation of Medicinal Products

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Better living through microbes

Article Abstract:

Streptococcus mutans is the species of the modified live bacteria that will replace their naturally occurring, acid-making counterparts, which lack the gene to make enamel-eroding lactic acid. Organics hopes that eventually the bacteria will become a routine part of dentistry, a one-time treatment applied to children's teeth before they start getting cavities.

Author: Baker, Monya
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2005
Streptococcus mutans, Genetically modified organisms, Dental caries research

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Anti-infective antibodies: Finding the path forward

Article Abstract:

Several pharmaceutical companies are investigating antimicrobial antibodies in their quest to find new weapons to fight infections. Increasing number of patients are dying from bacterial infections and therefore physicians are looking for better treatment and healthcare and the pharma companies are concentrating on antibiotic program.

Author: Baker, Monya
Publisher: Nature Publishing Co.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
Pharmaceutical Preparation Manufacturing, Antiinfective Preparations, Causes of, Anti-infective agents, Bacterial infections

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Subjects list: United States, Pharmaceutical industry, Research
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