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Sivacharan Kollipara

dr. reddy's laboratories ltd.
H指数:18
被引数:939

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Development of a novel rabeprazole modified release formulation to reduce the dosing frequency: A trial and triumph with physiologically based biopharmaceutics modeling

开发一种新型雷贝拉唑缓释制剂以减少给药频率:基于生理学的生物药剂学建模的尝试与成功

2026-05-160
PRE
Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges (Nov, 10.1007/s43441-025-00900-0, 2025)

在ICH M13B框架下对即释固体制剂探索额外规格生物豁免的观点:机遇与挑战

2026-01-010
PRE
Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel

利用模型集成生物等效性(MIBE)解决监管关切并豁免重复生物等效性研究——一项关于氯吡格雷的案例研究

2025-12-170
PRE
Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: a webinar summary

新兴观点:利用生理学基础的生物药剂学建模(PBBM)实现BCS第III类生物豁免:网络研讨会总结

2025-10-200
OAAI
Correction: Nitrosamines Risk Assessment for Biopharmaceutics Classifcation System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokinetic Modeling

更正:用于立即释放产品的生物药剂学分类系统IV类分子中硝基亚硝胺风险评估:应用计算机预测工具和生理基础药代动力学模型

2025-06-040
PRE
Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions

基于生理学的生物药剂学模型报告模板开发:从监管提交角度考虑的质量改进

2025-04-290
OA