Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence(BE)testing for approval of immediate release(IR)solid dosage forms containing moxifloxacin hydrochloride as the API...Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence(BE)testing for approval of immediate release(IR)solid dosage forms containing moxifloxacin hydrochloride as the API manufactured by the Government Pharmaceutical Organization(GPO)are evaluated.The solubility of moxifloxacin hydrochloride determined by the shake flask method in six different pH mediums(1.2,4.5,5.4,6.4,6.8 and 7.5)was 4.988±0.1962,27.012±0.4138,21.668±0.5165,47.200±0.8095,73.438±1.7310 and 196.475±4.4624 mg/mL,respectively.The Dose/Solubility(D/S)Ratio of the highest strength(400 mg)available in the market of moxifloxacin tablets was 80.192,14.808,18.460,8.475,5.447 and 2.036 mL,respectively.展开更多
Bioequivalence(BE) assessment of topical dermatological products is a long standing challenge. The development of generic topical dermatological products has often been hampered due to the limited number of acceptable...Bioequivalence(BE) assessment of topical dermatological products is a long standing challenge. The development of generic topical dermatological products has often been hampered due to the limited number of acceptable approaches, which are capable of determining the BE between generic products and reference list products. The aim of this manuscript is to review different BE assessment approaches of topical dermatological products. Besides, the advances in BE evaluation and biowaivers are also provided. Currently, except in the case of dermatological corticosteroids, the golden rule to establish the BE of most topical dermatological products still heavily relied on clinical endpoint trials,which are often unreliable, time-consuming and expensive. The regulatory agencies and pharmaceutical industries are forging ahead to the development of new surrogate BE assessment approaches for other topical dermatological products. These promising approaches include dermatopharmacokinetic study(DPK), dermal microdialysis(DMD), in vitro studies, pharmacokinetic study(PK), near-infrared spectrometry(NIR), and confocal Raman spectroscopy(CRS). In addition, the expansion of biowaivers for topical dermatological products has been explored by pharmaceutical scientists. In conclusion, to accelerate the development and approval of topical dermatological products, emphasis should be put on the following areas, i.e., optimizing and standardizing the existing BE assessment methods, exploring novel alternatives of BE assessment approaches, and expanding biowaivers for topical dermatological products.展开更多
文摘Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence(BE)testing for approval of immediate release(IR)solid dosage forms containing moxifloxacin hydrochloride as the API manufactured by the Government Pharmaceutical Organization(GPO)are evaluated.The solubility of moxifloxacin hydrochloride determined by the shake flask method in six different pH mediums(1.2,4.5,5.4,6.4,6.8 and 7.5)was 4.988±0.1962,27.012±0.4138,21.668±0.5165,47.200±0.8095,73.438±1.7310 and 196.475±4.4624 mg/mL,respectively.The Dose/Solubility(D/S)Ratio of the highest strength(400 mg)available in the market of moxifloxacin tablets was 80.192,14.808,18.460,8.475,5.447 and 2.036 mL,respectively.
文摘Bioequivalence(BE) assessment of topical dermatological products is a long standing challenge. The development of generic topical dermatological products has often been hampered due to the limited number of acceptable approaches, which are capable of determining the BE between generic products and reference list products. The aim of this manuscript is to review different BE assessment approaches of topical dermatological products. Besides, the advances in BE evaluation and biowaivers are also provided. Currently, except in the case of dermatological corticosteroids, the golden rule to establish the BE of most topical dermatological products still heavily relied on clinical endpoint trials,which are often unreliable, time-consuming and expensive. The regulatory agencies and pharmaceutical industries are forging ahead to the development of new surrogate BE assessment approaches for other topical dermatological products. These promising approaches include dermatopharmacokinetic study(DPK), dermal microdialysis(DMD), in vitro studies, pharmacokinetic study(PK), near-infrared spectrometry(NIR), and confocal Raman spectroscopy(CRS). In addition, the expansion of biowaivers for topical dermatological products has been explored by pharmaceutical scientists. In conclusion, to accelerate the development and approval of topical dermatological products, emphasis should be put on the following areas, i.e., optimizing and standardizing the existing BE assessment methods, exploring novel alternatives of BE assessment approaches, and expanding biowaivers for topical dermatological products.
