The present invention relates to an immediate release solid oral dosage form containing 1-aminocyclohexanes, preferably memantine or neramexane, and optionally a pharmaceutically acceptable coating, wherein the active ingredient exhibits dose proportionality and is released at a dissolution rate of more ...
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Bi...
bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing the antimalarial drug primaquine phosphate as the only active pharmaceutical ingredient (API) are reviewed. On the basis of permeability data and solubility studies, primaquine phosphate was found ...
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Isoniazid * Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral do... C Becker,JB Dressman,GL Amidon,... - 《Journal of ...
Literature and experimental data relevant to the decision to allow a waiver ofin vivobioequivalence (BE) testing for the approval of immediate‐release (IR) solid oral dosage forms containing ketoprofen are reviewed. Ketoprofen's solubility and permeability, its therapeutic use and therapeutic index, ...
fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms FDA Guidance for industry: dissolution testing of immediate release solid oral dosage forms. Rockville: FDA, 1997.p. 1-11.FDA guidance for Industry: dissolution testing of immediate release solid oral dosage...
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing acetazolamide are reviewed. Acetazolamide's solubility and permeability characteristics according to the Biopharmaceutics Classifica...
Guidance for industry dissolution testing of immediate release solid oral dosage forms This guidance is developed for immediate release (IR) dosage forms and is intended to provide (1) general recommendations for dissolution testing; (2) appr... CFD Evaluation 被引量: 736发表: 1997年 Biowaiver ...
Guidance for industry dissolution testing of immediate release solid oral dosage forms This guidance is developed for immediate release (IR) dosage forms and is intended to provide (1) general recommendations for dissolution testing; (2) appr... CFD Evaluation 被引量: 737发表: 1997年 Scaleup of...
Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms 机译:工业指南:立即释放固体口服剂型的溶出度测试 摘要 This guidance is developed for immediate release (IR) dosage forms and is intended to provide (1) general recommendations for dissolution testing; (2) approach...