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1. |
The SAMM guidelinesGuidelines for company‐sponsored Safety Assessment of Marketed Medicines |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 1-4
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PDF (312KB)
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ISSN:1053-8569
DOI:10.1002/pds.2630030103
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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2. |
Commentary on the guidelines for company sponsored safety assessment of marketed medicine (SAMM) |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 5-6
Myles Stephens,
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PDF (186KB)
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ISSN:1053-8569
DOI:10.1002/pds.2630030104
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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3. |
The medical dictionary for drug regulatory affairs (MEDDRA) project |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 7-13
K. L. Wood,
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PDF (491KB)
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摘要:
AbstractElectronic transmission of information is a key component of the Future System for medicines regulation in the European Union (EU). Data sets and terminology will have to be standardized in order to ensure effective information exchange between organizations. TheMedicalDictionary forDrugRegulatoryAffairs (MEDDRA) is a medical terminology being prepared by an international Working Party for use by regulatory authorities, pharmaceutical companies and other relevant organizations. It incorporates terms relevant to all areas of drug regulation, including the marketing authorization (MA) process, MA maintenance/renewal and pharmacovigilance.
ISSN:1053-8569
DOI:10.1002/pds.2630030105
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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4. |
The quality of information recorded on a UK database of primary care records: A study of hospitalizations due to hypoglycemia and other conditions |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 15-21
Tjeerd‐Pieter Van Staa,
Lucien Abenhaim,
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PDF (546KB)
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摘要:
AbstractWe assessed the utility of the clinical information on the VAMP Research data bank. This data bank contains information recorded by general practitioners in the United Kingdom. We compared information derived from photocopied hospital discharge summaries and GPs' questionnaires to the information recorded in the data bank. Data were obtained on 553 discharge summaries for 452 persons registered in 269 medical practices.We found that the principal diagnosis of hospitalizations was present in the computerized records in 90.0 per cent of the time. Furthermore, 90.7 per cent of the discharge summaries for hypoglycemia were adequately recorded on the data bank, and 88.6 per cent of the data bank codes indicating hypoglycemia hospitalizations were correct. For most of the other reviewed medical conditions, we found that the sensitivity of computer notation and positive predictive value of computer codes was over 90 per cent. The agreement between computerized information on the severity of diabetes and GPs' questionnaire information was over 85 per cent.We concluded that the data in the VAMP Research data bank have a high level of completeness and validity.
ISSN:1053-8569
DOI:10.1002/pds.2630030106
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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5. |
Antidepressant drug use in an ambulatory elderly population: A 14‐year overview |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 23-29
Ronald B. Stewart,
Ronald G. Marks,
Phillip D. Padgett,
William E. Hale,
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摘要:
AbstractThe objective of the work was to identify changes in antidepressant drug use and determine if the prevalence of antidepressant use has changed over 14 years. A longitudinal analysis comparing antidepressant drug use at 14 yearly intervals from 1978–79 to 1991–92 was undertaken using the longitudinal health screening program of ambulatory elderly participants (Florida Geriatric Research Program). Participants included all subjects screened in the Florida Geriatric Research Program from 1 August 1978 to 31 July 1992. The outcome measures were self‐reported antidepressant drug use.Approximately 3.0 per cent (range of 2.3 to 3.2 per cent over 14 yearly intervals) of participants in this program reported the use of an antidepressant drug. There was no statistically significant change in antidepressant use between 1978–79 and 1991–92 (p>0.6630). Across all study intervals women reported more frequent use of antidepressant drugs than men. In 1991–92, amitriptyline and imipramine represented over 50 per cent of all antidepressant drug use in this elderly population. Less than 6 per cent of all antidepressant drug use was for fluoxetine, the newest selective serotonin uptake inhibitor.The majority of elderly patients are receiving older tertiary amine tricyclic antidepressants such as amitriptyline, imipramine and doxepin that are not the preferred drugs for the elderly. Educational programs are needed to improve antidepressant prescribing for geriatr
ISSN:1053-8569
DOI:10.1002/pds.2630030107
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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6. |
Adverse drug reactions in HIV seropositive patients |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 31-40
C. Benichou,
M. Eliaszewicz,
A. Flahault,
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摘要:
AbstractPatients infected with the human immunodeficiency virus (HIV) will receive a number of drugs intended to fight the HIV infection itself or to avoid and treat its complications. In these patients, adverse drug reactions (ADRs) are unusual in their frequency, not in their type. They may involve all the systems and reduce the already limited therapeutic possibilities. The frequent absence of therapeutic alternatives may require, for certain reactions, the continuation of the suspected drug.The study of these patients may provide better comprehension of the mechanisms responsible for ADRs occurring in immuno‐competent patients, since the association of certain diseases with certain drugs increases the risk of drug reactions. The search for an enhancing, synergistic or at least a non‐neutralizing mechanism may improve the study or the prevention of all ADRs.The spread of HIV infection and the attempt to maintain the infected patient at home means that any physician is likely to be confronted with the diagnosis and treatment of a drug‐related toxicity in an HIV‐positive patient.In May 1993, a certain number of physicians who had specialized in the treatment of HIV‐infection and/or in management of ADRs, met to discuss the different toxicities observed with the drugs most often employed in this illness. The description, the incidences and the recommendations which are presented in this report reflect the opinion of a large majority — and often the unanimity — of the
ISSN:1053-8569
DOI:10.1002/pds.2630030108
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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7. |
Calcitonin and epistaxis |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 41-42
Pilar Alvarez,
Albert Figueras,
Dolors Capella,
Joan‐Ramon Laporte,
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PDF (136KB)
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ISSN:1053-8569
DOI:10.1002/pds.2630030109
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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8. |
Pharmaceutical medicine a textbook of current practice. R. D. Mann, M. D. Rawlins and R. M. Auty (eds), Parthenon Publishing Group, Carnforth, UK and New York, 1993, 461 pp. |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 43-43
Walter O. Spitzer,
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PDF (90KB)
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ISSN:1053-8569
DOI:10.1002/pds.2630030110
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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9. |
Pharmacoepidemiology and drug safety |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page 45-60
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PDF (1942KB)
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ISSN:1053-8569
DOI:10.1002/pds.2630030111
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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10. |
Editorial |
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Pharmacoepidemiology and Drug Safety,
Volume 3,
Issue 1,
1994,
Page -
R. D. Mann,
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PDF (162KB)
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ISSN:1053-8569
DOI:10.1002/pds.2630030102
出版商:John Wiley&Sons, Ltd.
年代:1994
数据来源: WILEY
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