On one hand, generic drug formulations provide cost savings for patients and society. On the o... SJ Shaw,AL Hartman - 《Journal of Pediatric Pharmacology & Therapeutics Jppt the Official Journal of Ppag》 被引量: 41发表: 2010年 Single dose pharmacokinetic equivalence study of two gabapentin ...
To achieve QbD objectives, product and process characteristics important to desired performance must be derived from a combination of prior knowledge and experimental assessment during product development.” Pharmaceutical Quality = ? (Drug substance, excipients, manufacturing, and packaging) 5 Regulatory ...
At the 2008 ASMS conference we presented our work on the development of several comprehensive generic automation procedures for LC-MS/MS applications on the Hamilton Microlab AT plus 2 robot using 96-well protein precipitation (PPT) plates. To better support Novartis drug development programs and ...
Food and Drug Administration (FDA)-approved biocompatible polymers, such as poly(lactic-co-glycolic acid), or PLGA. Despite significant progress and development in the global pLAI market, FDA guidance for the approval of complex drug products, such as generic pLAIs, is not clearly defined. ...
4.3. Prevalence of Multidrug Resistance Of the 88.8% MDR ESCr in the current study, most (45.1%) were resistant to antimicrobials in six different drug classes. The most common MDR patterns in ESCr involved combinations of oxytetracycline, ampicillin, streptomycin, ceftiofur, florfenicol and ...
Food and Drug Administration (FDA), including a single generic product, sodium ferric gluconate complex in sucrose. In this study, we compared the cellular iron uptake profiles of the brand (Ferrlecit®) and generic sodium ferric gluconate (SFG) products. We used a colorimetric assay to ...
RASA: A rapid retrosynthesis-based scoring method for the assessment of synthetic accessibility of drug-like molecules. J. Chem. Inf. Model. 2011, 51, 2768–2777. [CrossRef] [PubMed] 10. Satoh, K.; Funatsu, K. A Novel Approach to Retrosynthetic Analysis Using Knowledge Bases Derived from...