Allphase Pharma Consulting, LLC
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Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to a single-digit factor. In other words, as more data accrue, Continue reading The Letermovir Top-Line Results are Out – Or Are They?
Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead of 250 mg IM) or with azithromycin combination therapy. Worse Continue reading GC Therapy – Shooting for the Stars
Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; for antibiotics, however, an effective dose can be predicted nowadays Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?