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L. Ann Tanner - One of the best experts on this subject based on the ideXlab platform.

  • Postmarketing Surveillance: curriculum for the clinical pharmacologist. Part I: Postmarketing Surveillance within the continuum of the drug approval process.
    Journal of clinical pharmacology, 1993
    Co-Authors: Joyce B. Johnson, L. Ann Tanner
    Abstract:

    This series of two articles on Postmarketing safety Surveillance has been developed for use in training clinical pharmacologists. It provides a basic overview useful to clinical pharmacologists in a range of occupational functions. These reports can be used as the basis for a lecture or as background reading material for establishing a unit on Postmarketing Surveillance. For teaching rounds, multiple illustrations and summary tables have been included. These can readily be made into 35-mm slides or transparencies. Table I outlines the curriculum on Postmarketing Surveillance for the clinical pharmacologist. The first article describes Postmarketing Surveillance within the continuum of the drug approval process. The relationship of clinical trials to safety Surveillance after drug approval are reviewed. The importance of spontaneous adverse drug experience reporting also is discussed. The second article focuses on the regulatory aspects of Postmarketing Surveillance and discusses the FDA's (Food and Drug Administration) Spontaneous Reporting System. The two types of adverse experience reports in the Spontaneous Reporting System are described: reports voluntarily submitted by health care providers and others, and reports manufacturers are required by regulation to submit. The clinical pharmacologist's role in Postmarketing Surveillance is defined.

  • Postmarketing Surveillance: Curriculum for the Clinical Pharmacologist. Part II: Clinical and Regulatory Considerations
    Journal of clinical pharmacology, 1993
    Co-Authors: Joyce M. Johnson, L. Ann Tanner
    Abstract:

    This is the second of a two-part series that develops a curriculum on Postmarketing Surveillance. With the ongoing emphasis on drug safety and possible earlier marketing of drugs, this becomes an essential element of clinical pharmacology training. The usual educational focus on drug safety is a pharmacokinetic or pharmacodynamic perspective on a specific drug or drug class, perhaps in the context of clinical trial study design and analysis. This curriculum complements this approach and provides an overview of drug safety Surveillance from regulatory and epidemiologic perspectives.

Hisashi Yamanaka - One of the best experts on this subject based on the ideXlab platform.

  • Postmarketing Surveillance of the safety and effectiveness of abatacept in japanese patients with rheumatoid arthritis
    Modern Rheumatology, 2016
    Co-Authors: Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Tsutomu Takeuchi, Yoshiya Tanaka, Tsuneyo Mimori, Junnosuke Ryu, Syuji Takei, Yoshinari Takasaki, Hisashi Yamanaka
    Abstract:

    AbstractObjective: To perform a Postmarketing Surveillance study evaluating the safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis (RA).Methods: Safety and effectiveness data were collected for all RA patients (at 772 sites) treated with intravenous abatacept between September 2010 and June 2011. Patients were treated by the approved dosing regimen according to the package insert. Treatment effectiveness was evaluated at baseline and at weeks 4, 12, and 24 using Disease Activity Score 28 (DAS28) according to erythrocyte sedimentation rate or serum C-reactive protein concentrations.Results: Overall, 3882 and 3016 abatacept-naive RA patients were included in safety and effectiveness analyses, respectively. Adverse drug reactions (ADRs) were reported for 15.66% of patients and serious ADRs were detected for 2.52% of patients. The incidence of serious infections was 1.03% and these were mainly attributed to different types of bacterial pneumonia. Disease activity improved sig...

  • Postmarketing Surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis
    Modern Rheumatology, 2011
    Co-Authors: Takao Koike, Masayoshi Harigai, Shigeko Inokuma, Naoki Ishiguro, Tsutomu Takeuchi, Yoshiya Tanaka, Hisashi Yamanaka, Koichi Fujii, Takunari Yoshinaga, Bruce Freundlich
    Abstract:

    Our aim was to evaluate real-world safety and effectiveness in a 6-month Postmarketing Surveillance study covering all Japanese patients with rheumatoid arthritis (RA) who received etanercept during a 2-year period. Data for 13,894 patients (1334 sites) enrolled between March 2005 and April 2007 were collected. Adverse events (AEs) and serious adverse events (SAEs) were reported in 4336 (31.2%) and 857 (6.2%) patients, respectively. The most frequent AEs were injection site reactions ( n  = 610, 4.4%) and rash ( n  = 339, 2.4%), whereas pneumonia ( n  = 116, 0.8%) and interstitial lung disease ( n  = 77, 0.6%) were the most frequent SAEs. Significant improvement in the proportion of patients with a good European League Against Rheumatism (EULAR) response was observed from week 4 (17.6%) to week 24 (31.6%) ( p  

Chris Ellyn Johanson - One of the best experts on this subject based on the ideXlab platform.

  • Postmarketing Surveillance of abuse liability of sibutramine
    Drug and alcohol dependence, 2003
    Co-Authors: Cynthia L. Arfken, Charles R. Schuster, Chris Ellyn Johanson
    Abstract:

    Abstract The abuse liability of medications is a growing concern as the number of newly approved psychoactive medications increases. Postmarketing Surveillance can assist in determining abuse liability, but strategies are not well-defined for medications believed to be at low abuse risk. Using a newly approved medication (sibutramine—an anorectic drug), a novel approach to Postmarketing abuse Surveillance was introduced. A one-page anonymous questionnaire covering sibutramine, a scheduled anorectic drug (phentermine), and a fabricated name was added to the intake process of 58 treatment programs. From the 8780 completed questionnaires, 8.8% had heard of sibutramine and phentermine. For continued use to get high (a proxy for abuse), the rate for sibutramine was lower than for phentermine (0.6 vs. 2.2%, McNemar's χ 2 =110.45, P χ 2 =11.86, P

Jan M Friedman - One of the best experts on this subject based on the ideXlab platform.

  • abcdxxx the obscenity of Postmarketing Surveillance for teratogenic effects
    Birth Defects Research Part A-clinical and Molecular Teratology, 2012
    Co-Authors: Jan M Friedman
    Abstract:

    Our current system of Postmarketing Surveillance, which is based on voluntary reporting of suspected teratogenic effects, is a failure. Postmarketing Surveillance should, at a minimum, provide reassurance that every approved drug treatment does not produce a teratogenic effect as great as thalidomide embryopathy or fetal alcohol syndrome. This means that Postmarketing Surveillance should be able to detect a twofold or greater increase in the frequency of major congenital anomalies, a fivefold or greater increase in the frequency of intellectual disability, or a characteristic pattern of minor anomalies and functional abnormalities that occurs with a frequency of at least 10% among the children of women who were treated with the drug during pregnancy. Effective Surveillance for teratogenic effects could be accomplished through a complementary set of mechanisms that includes pregnancy exposure registries or cohorts as well as direct examination of a small subset of infants whose mothers received the treatment during various periods of pregnancy. If this routine Surveillance reveals a "signal" (i.e., an indication suggesting a possible teratogenic effect), further study would be needed to establish whether the observed effect is real and causal. Once a signal of possible teratogenicity in humans has been recognized, validating or refuting it would become an urgent matter.

  • ABCDXXX: The obscenity of Postmarketing Surveillance for teratogenic effects.
    Birth defects research. Part A Clinical and molecular teratology, 2012
    Co-Authors: Jan M Friedman
    Abstract:

    Our current system of Postmarketing Surveillance, which is based on voluntary reporting of suspected teratogenic effects, is a failure. Postmarketing Surveillance should, at a minimum, provide reassurance that every approved drug treatment does not produce a teratogenic effect as great as thalidomide embryopathy or fetal alcohol syndrome. This means that Postmarketing Surveillance should be able to detect a twofold or greater increase in the frequency of major congenital anomalies, a fivefold or greater increase in the frequency of intellectual disability, or a characteristic pattern of minor anomalies and functional abnormalities that occurs with a frequency of at least 10% among the children of women who were treated with the drug during pregnancy. Effective Surveillance for teratogenic effects could be accomplished through a complementary set of mechanisms that includes pregnancy exposure registries or cohorts as well as direct examination of a small subset of infants whose mothers received the treatment during various periods of pregnancy. If this routine Surveillance reveals a “signal” (i.e., an indication suggesting a possible teratogenic effect), further study would be needed to establish whether the observed effect is real and causal. Once a signal of possible teratogenicity in humans has been recognized, validating or refuting it would become an urgent matter. Birth Defects Research (Part A) 94:670–676, 2012. © 2012 Wiley Periodicals, Inc.

Miyo Ota - One of the best experts on this subject based on the ideXlab platform.