Future Prospects of Proteolytic Enzymes and Wound Healing
A review of the literature makes it clear that the effects of the various proteolytic enzymes presently on the market have not been sufficiently investigated in double-blind placebo-controlled clinical trials. This is primarily because most of these enzyme preparations were introduced a long time ago, when the regulations of the health authorities were not very strict. Furthermore, the evaluation methods and end-point criteria for a clinical study were not very accurate. Finally, most of the studies suffered a lack of stratification, involving huge numbers of patients, mostly in poorly organized multi center trials. This is now going to change. The Food and Drug Administration of the USA and the Committee for Proprietary Medicinal Products of the FC have set very strict guidelines on the quality, safety, and efficacy of medicinal products for human use. This means that many existing products have to be filed again for registration according to the new guidelines of good clinical, laboratory, and manufacturing practice.
KeywordsMigration Azine Trypsin Stratification Collagenase
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