FDA批准了百济神州美国分公司生产Brukinsa。 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical de...
在整个生理pH值范围内显示出水溶性差(低于0.015 mg/mL)，为BCS II类化合物。 因此，进行一种在预测与RLD药动学等效方面起最佳作用的溶出方法的开发，以允许评估开发期间acetriptan片的生产。The target is an immediate release product, so dissolution in the stomach and absorption in the upper small intest...
Additionally, for generic immediate releasesolid oral drug products including a highly soluble drug substance (per theBiopharmaceutics Classification System (BCS) definition5), the Agencyrecommends that dissolution QC testing be conducted as described in FDA’sguidance for industry Dissolution Testing and ...
FDA批准首个细胞疗法治疗不可切除或转移性黑色素瘤患者 For Immediate Release:February 16, 2024 Amtagvi是一种肿瘤衍生的自体T细胞免疫疗法,由患者自身的T细胞组成,T细胞是一种帮助免疫系统对抗癌症的细胞。在治疗前的手术过程中,切除一部分患者的肿瘤组织。患者的T细胞从肿瘤组织中分离出来,进一步制造,然后以单剂量的...
and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release product...
Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S. For Immediate Release:December 05, 2019 Statement From: Director - Center for Drug Evaluation and Research Janet Woodcock M.D. ...
For Immediate Release: November 14, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. ...
Additionally, for generic immediate releasesolid oral drug products including a highly soluble drug substance (per theBiopharmaceutics Classification System (BCS) definition5), the Agencyrecommends that dissolution QC testing be conducted as described in FDA’sguidance for industry Dissolution Testing and ...
The target is an immediate release product, so dissolution in the stomach and absorption in the upper small intestine is expected suggesting the use of dissolution medium with low pH. Development began with the quality control dissolution method recommended for this product by the FDA: 900 mL of...
For Immediate Release December 13, 2017 Summary New website streamlines how FDA updates information used to help health care providers choose an appropriate treatment for a patient’s infection Release Today the U.S. Food and Drug Administration is announcing a new approach to get critical updates...