Surveillances studies

The FDA may also require manufacturers to conduct post-market surveillance studies for Class II and III devices that meet the following criteria ... 

Kopp AF, Mortele KJ, Cho YD, et al Prevalence of acute reactions to iopromide postmarketing surveillance study of74,717 patients. Acta Radiol 2008 49 902-911. 

General Lab. and Pharma. Lab. participate In proficiency-testing studies and market surveillance studies organised by European Department for Quality of... 

Table 5—Radioactive decay scheme data for radionuclides of cerium observed in previous environmental surveillance studies ...

Kahn, B., Blanchard, R. L., Krieger, H. L., Kolde, H. E., Smith, D. B., Martin, A., Gold, S., Averett, W. J Brinck, W. L. and Karches, G. J. (1970). Radiological Surveillance Studies at a Boiling Water Nuclear Power Reactor, Report No. BRH/DER-70-1, also Report No. PB-191091 (Bureau of Radiological Health, Rockville, Maryland). 

Postmarketing Surveillance Studies. Any surveillance of safety of a drug after marketing is postmarketing surveillance (PMS) (now often referred to as a postauthorization safety study). In practice the distinction between Phase TV studies and PMS is blurred (e.g., German drug experience studies). 

ROCK C L, THORNQUIST M D, KRISTAL A R, PATTERSON R E, COOPER D A, NEUHOUSER M L, neumark-sztainer D and cheskin l j (1999), Demographic, dietary and lifestyle factors differentially explain variability in serum carotenoids and fat-soluble vitamins baseline results from the sentinel site of the Olestra Post-Marketing Surveillance Study , J Nutr, 129(4), 855-64. rodale (1996), The Prevention Index - a report card on the nation s health, 1996 summary report. Rodale Press, Inc, Emmaus, Pennsylvania. SANDLER R S, ZORICH N L, FILLOON T G, WISEMAN H B, LIETZ D J, BROCK M H, ROYER M G and MIDAY R K (1999), Gastrointestinal symptoms in 3181 volunteers ingesting snack foods containing olestra or triglycerides , Annals Internal Med, 130, 253-61. 

Closing volume measurement, 29S-96 Colorimetric analysis for air monhoriqg, 262-64,27S to measure nitrogen oxides, 269 Community Health Effects Surveillance Studies (chess), 9,432 Concentration. See Ozone otmcentration Feroi aoetyliiitrate concentration Photochemical-oxidant concentration... 

Some large, multicentre post-marketing surveillance studies, in which a comparison of the newly marketed drug and standard therapy is made... 

These deliberations may result in several outcomes. Clinical development may continue as planned, but additional vigilance with more frequent visits and special tests may be added. The dose may be reduced or certain at-risk subjects may be excluded from further trials. The drug may proceed to registration, but the authorities may stipulate that a post-marketing surveillance study be conducted. The drug may even be withdrawn from further clinical development. 

In this context, a decision on whether postmarketing surveillance studies should be built into the development programme must be taken. Such an observational study may signal the occurrence of adverse events or alternatively it may signal and quantify the frequency of adverse events. At this point in the life cycle of a new medicine, post-marketing surveillance is likely to involve cohort observational studies of 10-20 000 patients. The value of these studies is likely to be three-fold ... 

Waller PC, Wood SM, Langman MJS, et al. Review of company postmarketing surveillance studies. BMJ 1992 304 1470-2. 

HiU PL, Bridgman KM. A multicentre postmarketing surveillance study to evaluate the safety of bisoprolol in the treatment of hypertension and ischaemic heart disease. Br ] Clin Res 1992 3 85-98. 

Wilton LV, Heeley El, Pickering RM, et al. Comparative study of mortahty rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine. J Psychophar-macol 2001 15 120-6. 

Market research activities, post-marketing surveillance studies, clinical assessments and the like must not be disguised promotion. 

Prospective surveillance study of medium chain acyl-CoA dehydrogenase deficiency in the UK. 

Schneider, H. J., E. Honold, and T. Masuhr. Treatment of benign prostatic hyperplasia. Results of a surveillance study in the practices of urological specialists using a combined plant-based preparation (Sabal extract WS 1473 and Urdca extract WS 1031). Fortschr Med 1995 113(3) 37-40. 

M.T. Hedges T.J. Mahler, "Surveillance Study of Nickel-Zirconium Type Delay Powder for M205 Hand Grenade Fuze ,... 

Many of the tests described earlier have been applied in surveillance studies of solid propellants. Both response and failure characteristics may be followed as a function of time during storage at various conditions. Physicochemical analysis of specimens before and after exposure to... 

Phase 4, post-marketing surveillance studies. Often organised by drug manufacturers, they can provide valuable additional information from large numbers of patients. 

Gardner, J.S., Blough, D., Drinkard, C.R., Shatin, D., Anderson, G., Graham, D., Alderfer, R. Tramadol and seizures a surveillance study in a managed care population, Pharmacotherapy 2000, 20, 1423-1431. 

Schramm G, Steffens D. Contraceptive efficacy and tolerability of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (Belara) results of a post-marketing surveillance study Chn Drug Invest 2002 22 221-31. 

Hannaford P. Postmarketing surveillance study of Norplant in developing countries. Lancet 2001 357(9271) 1815-6. 

In a post-marketing surveillance study in 27 803 patients with diabetes mellitus (94% type 2), data were reported after 12 weeks. The doses of acarbose were low 4.1% took less than 100 mg/day, 64% 100-250 mg/day, 32% 250-300 mg/day, and 0.1% more than 300 mg/day. Only 2.1% stopped therapy, mainly because of gastrointestinal adverse events. Tolerability appeared to be good and independent of age. Abnormal liver function was reported in 0.01%. The difference between these results and those of many controlled trials may in part be explained by the fact that higher doses have been used in most trials (14). 

In a post-marketing surveillance study of 1142 patients in whom acarbose was added to insulin therapy for type 2 diabetes mellitus, HbAlc improved by 0.9% and there were 108 adverse effects in 6.9% of the patients (45). Most of the complaints were gastrointestinal (flatulence, abdominal pain, diarrhea) and more than half were reported in the first week of acarbose therapy. 

Mertes G. Efficacy and safety of acarbose in the treatment of type 2 diabetes data from a 2-year surveillance study. Diabetes Res Clin Pract 1998 40(l) 63-70. 

Spengler M, Schmitz H, Landen H. Evaluation of the efficacy and tolerability of acarbose in patients with diabetes mellitus. A post marketing surveillance study Clin Drug Invest 2005 25 651-9. 

Anwendungs beobachtung bei 676 patienten. [Ciprofloxacin in the treatment of hospital-acquired pneumonia a surveillance study in 676 patients.] Pneumologie 2002 56(10) 599-604. 

In a post-marketing surveillance study in 8760 patients for 16 weeks the most common serious adverse effect was weight gain, followed by edema of the legs, nausea, headache, and dizziness (26). 

Schofl C, Liibben G. Postmarketing surveillance study of the efficacy and tolerability of pioglitazone in insulin-resistant patents with type 2 diabetes mellitus in general practice. Clin Drug Invest 2003 23 725-34. 

Lombardi C Safety of sublingual immunotherapy with monomeric allergoid in adults Multicenter post-marketing surveillance study. Allergy 2001 56 989-992. 

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