topical antisepticstopical antibioticsguinea pig sensitizationA predictive study comparing the sensitizing potentials of some topical antimicrobials, using a modified Beuhler's technique, showed that over-the-counter (OTC) antimicrobials were more sensitizing than prescribed topical antibiotics. Among OTC ...
Topical medicaments can induce iatrogenic cutaneous disease. These adverse cutaneous reactions may be facilitated by previous dermatoses (like leg ulcers or long-standing dermatitis), by the route or special conditions under which they are applied (transdermal devices) and by the intrinsic allergenic p...
Bioequivalence is generally not required for over-the-counter products, nor is it necessarily a concern for drugs or products that do not now come under regulatory scrutiny. This chapter will not address bioavailability/bioequivalence of products that are applied topically but are designed to ...
antisepticsherbal wound‐care productswound‐debridement agentscorticosteroidsaerosol spraysSummary Topical treatments have been used in wound care for centuries. Many of the treatments, however, have not – or only to a very limited degree – undergone scientific scrutiny. This is especially true for ...
In addition, it was neither cytotoxic nor an inductor of necrosis–apoptosis in neutrophils (ex vivo assays) or inflammatory response (in vivo studies in a mouse model), compared with acetic acid or antiseptics typically used in the treatment of these infections [13]. Based on these previous ...
When developing an antiseptic drug product, there are two options a manufacturer can pursue: the new drug application (NDA) process or the over-the-counter (OTC) drug review known as the monograph system. Table 4 shows the legal distinctions between NDA-WWE DOBiosciencelabs Com...