Defining dose decrease

Pharmacoepidemiology and Drug Safety

Volumn 12, Issue 2, 2003, Pages 151-152

  Temple, Robert J ^a  

^a Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ANTIFUNGAL AGENT; ASTEMIZOLE;

CONCENTRATION (PARAMETERS); DOSE RESPONSE; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG DOSE REDUCTION; DRUG INDICATION; DRUG INFORMATION; DRUG LABELING; DRUG MARKETING; DRUG SCREENING; DRUG TOLERABILITY; DRUG WITHDRAWAL; HUMAN; LETTER; PRIORITY JOURNAL; SIDE EFFECT;

CLINICAL TRIALS, PHASE III; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG LABELING; HUMANS; MEDICATION ERRORS; PHARMACEUTICAL PREPARATIONS;

EID: 0037337016     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.812     Document Type: Letter

References (5)

1. Cross J, Lee H, Westelinck A, Nelson J, Grudzinskas C, Peck C. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999. Pharmacoepidemiol Drug Safe 2002; 11: 439-446.
2. Temple R. Dose-response and registration of new drugs. In Dose-Response Relationships in Clinical Pharmacology, Lasagna L, Erill S, Naranjo CA (eds). Elsevier Science Publishers B.V. (Biomedical Division): New York, 1989; 145-170.
3. International Conference on Harmonisation. Guidance for industry: dose-response information to support drug registration. http://www.fda.gov/cder/guidance/iche-4.pdf [16 February 2001].
4. U.S. Department of Health and Human Services. Guidance for industry: exposure-response relationships: study design, data analysis, and regulatory applications. http://www.fda.gov/cder/guidance/4614dft.pdf [March 2002].
5. Cohen JS. Dose discrepancies between the Physician's Desk Reference and the medical literature, and their possible role in the high incidence of dose-related adverse drug events. Arch Intern Med 2001; 161: 957-964.