Regulatory Concerns at Various Phases of Drug Development

Aurecchia, Steven A.; Orloff, David G.; Sobel, Solomon

doi:10.1016/s0002-9149(98)00250-1

Cited by 8 publications

(2 citation statements)

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“…These studies may enroll a larger number of patients and are randomized and blinded. [14] Phase 2b determines dose response in order to plan the ultimate dosing regimen for the pivotal phase 3 studies. Phase 2b studies are useful in confirming the mechanism of action.…”

Section: Phasementioning

confidence: 99%

Safety and Efficacy: The Role of Chemistry, Manufacturing, and Controls in Pharmaceutical Drug Development

Difeo

2004

Drug Development and Industrial Pharmacy

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Section: Phasementioning

confidence: 99%

Safety and Efficacy: The Role of Chemistry, Manufacturing, and Controls in Pharmaceutical Drug Development

Difeo

2004

Drug Development and Industrial Pharmacy

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“…These difficulties were addressed in 1998 by Aurecchia et al [33]. They suggested that in this therapeutic area, Phase I studies should be designed to assess single-and multiple-dose drug tolerance and to obtain sufficient information on the drug's pharmacokinetic and pharmacodynamic effects to permit rational design of Phase II trials.…”

Section: Developmental Hurdlesmentioning

confidence: 99%

Inhibition of acyl coenzyme a-cholesterol acyltransferase: A possible treatment of atherosclerosis?

Heinonen

2002

Curr Atheroscler Rep

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Our full understanding of atherosclerosis and our ability to prevent its sequellae are incomplete. As a result, further investigation of novel antiatherosclerotic mechanisms and agents continues. Acyl coenzyme A-cholesterol acyltransferase (ACAT) inhibition has been evaluated as a potential mechanism by which the current treatment arsenal may be expanded. ACAT is present in a variety of tissues and is responsible for catalyzing the conversion of free cholesterol to the more readily stored cholesteryl esters. Impressive lipid effects demonstrated in animals have not generally been demonstrated in human clinical trials. Partial ACAT inhibition with specific agents has resulted in lesion regression and decreased progression, whereas complete ACAT inhibition via genetic alterations has led to an exacerbation of cholesterol deposition in tissues in animal models. No ACAT inhibitor has yet been fully evaluated in human clinical trials for its impact on atherosclerotic disease progression. Several hurdles, such as sample size requirements needed to detect effect over background therapy and lack of sensitive surrogate efficacy markers, have served as a deterrent to the development of this class of investigational drug. However, with recent technologic advancements, more sensitive methods of measuring disease progression may be available. Human clinical trials are currently underway, with several agents reported in Phase II clinical trials. Within the next few years, results from these trials may determine whether or not ACAT inhibitors will be added to the list of treatment options for the prevention of atherosclerotic disease progression.

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Black

2002

The American Journal of Cardiology

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Regulatory Concerns at Various Phases of Drug Development

Cited by 8 publications

References 0 publications

Safety and Efficacy: The Role of Chemistry, Manufacturing, and Controls in Pharmaceutical Drug Development

Safety and Efficacy: The Role of Chemistry, Manufacturing, and Controls in Pharmaceutical Drug Development

Inhibition of acyl coenzyme a-cholesterol acyltransferase: A possible treatment of atherosclerosis?

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