CLINICAL PROTOCOL;
CLINICAL TRIAL;
DRUG APPROVAL;
DRUG DEVELOPMENT;
DRUG EFFICACY;
DRUG MARKETING;
DRUG MONITORING;
DRUG SAFETY;
GOOD CLINICAL PRACTICE;
HUMAN;
LICENSING;
LUPUS ERYTHEMATOSUS NEPHRITIS;
METHODOLOGY;
PRIORITY JOURNAL;
RHEUMATOID ARTHRITIS;
SHORT SURVEY;
SYSTEMIC LUPUS ERYTHEMATOSUS;
UNITED STATES;
CLINICAL TRIALS;
HUMANS;
LUPUS ERYTHEMATOSUS, SYSTEMIC;
LUPUS NEPHRITIS;
PHARMACEUTICAL PREPARATIONS;
PRACTICE GUIDELINES;
RESEARCH DESIGN;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
The Food and Drug Administration's Development, issuance, and use of guidance documents
February 27
The Food and Drug Administration's Development, Issuance, and Use of Guidance Documents. Federal Register February 27, 1997; 62: 8961-8972, www.fda.gov/cder/guidance/index.hmi.
FDA Arthritis Advisory Committee. Silver Spring MD
Design and assessment of clinical trials of drugs, biologies and devices that are being developed for treatment of systemic lupus erythematosus FDA Arthritis Advisory Committee. Silver Spring MD, 1999, www. fda.gov/cder99t.htm#Arthritis.
Guidance for Industry: Clinical development programs for drugs, devices and biological products for the treatment of rheumatoid arthritis (RA). FDA guidance document, 1999, www.fda.gov/cder/guidance/.
Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent?
Felson DT, Anderson JJ, Lange ML, Wells G, LaValley MP. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent? Arthritis Rheum 1998; 41: 1564-1570.
A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus. The Canadian Hydroxychloroquine Study Group
A randomized study of the effect of withdrawing hydroxychloroquine sulfate in systemic lupus erythematosus. The Canadian Hydroxychloroquine Study Group. N Engl J Med 1991; 324: 150-154.
Progression and remission of renal disease in the Lupus Nephritis Collaborative Study. Results of treatment with prednisone and short-term oral cyclophosphamide
Levey AS, Lan SP, Corwin HL et al. Progression and remission of renal disease in the Lupus Nephritis Collaborative Study. Results of treatment with prednisone and short-term oral cyclophosphamide. Ann Intern Med 1992; 116: 114-123,
'Nephritic flares' are predictors of bad long-term renal outcome in lupus nephritis
Moroni G, Quaglini S, Maccario M, Banfi G, Ponticelli C. 'Nephritic flares' are predictors of bad long-term renal outcome in lupus nephritis. Kidney Int 1996; 50: 2047-2053.
