K. Kaitin

Publications105
h-index26
Citations1,824
Highly Influential Citations41
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Assessing the Impact of Protocol Design Changes on Clinical Trial Performance
TLDR
The results of this study indicate that the number of unique procedures and the frequency of procedures per protocol have increased at the annual rate of 6.5% and 8.7%, respectively, during the time period measured, and implications for simplifying protocol designs and minimizing negative effects on study conduct performance are discussed.
View on Wolters Kluwer
Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspective
View on Wiley
Muscarinic cholinergic receptors and the canine model of narcolepsy.
TLDR
This up-regulation of brainstem cholinergic receptors suggests a problem with release of acetylcholine, which, together with previous reports of an impairment of dopamine release, may be indicative of a fundamental membrane problem in narcolepsy.
View on PubMed
Oncology drug development and approval of systemic anticancer therapy by the U.S. Food and Drug Administration.
TLDR
Approval of oncology agents is occurring in increasingly more challenging settings, suggesting gaps between eventual practice and development in potentially suboptimal indications.
View on PubMed
A dearth of new meds.
The authors looks at a study by the Tufts Center for the Study of Drug Development, which found that pharmaceutical companies are no longer producing new central nervous system medicines to treat…
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The evolution of biotechnology and its impact on health care.
TLDR
The future impact of biotechnology is promising, as long as the public and private sectors continue to foster policies and provide funds that lead to scientific breakthroughs and all stakeholders establish policies to ensure that the therapeutic advances that mitigate or cure medical conditions that currently have inadequate or no available therapies are accessible to the public at a reasonable cost.
View on PubMed
The Biotechnology Innovation Machine: A Source of Intelligent Biopharmaceuticals for the Pharma Industry—Mapping Biotechnology's Success
  • R. Evens, K. Kaitin
  • Biology, Engineering
    Clinical pharmacology and therapeutics
  • 1 May 2014
The marriage of biotechnology and the pharmaceutical industry (pharma) is predicated on an evolution in technology and product innovation. It has come as a result of advances in both the science and…
View on Wiley
Regulatory watch: Innovative drug availability in China
TLDR
The availability in China of new drugs approved by the US Food and Drug Administration during 2004–2014 was investigated and it was found that several innovative cancer drugs were approved in China more than 10 years after its initial approval in the United States.
View on Nature
The effects of buspirone on sleep in the rat
View on Elsevier
Sleep fragmentation in canine narcolepsy.
TLDR
A severe disturbance of the normal sleep pattern in canine narcoleptics is demonstrated and the possibility of a general dysfunction of circadian organization is discussed.
View on PubMed
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