主页 / Author / Rajesh Krishna, PhD

Rajesh Krishna, PhD

Distinguished Scientist, Drug Development Science

Rajesh Krishna, PhD, is a Distinguished Scientist in Drug Development Science and lead of the integrated practice area on rare diseases at Certara Strategic Consulting. 他在制药行业和咨询行业共有约 25 年的丰富经验，已为逾 40 个新药临床试验申请 (IND)、逾 200 项 1/1b 期研究，及数项新药上市申请 (NDA)/生物制品许可申请 (BLA) 提供支持。他是 Raj 的临床药理学博客的作者。

Authored by Rajesh Krishna, PhD

Clinical Pharmacology & Pharmacometrics Should Collaborate to Implement Model-Informed Drug Development

博客

Why you should select your drug formulation before starting clinical studies

博客

Key development considerations for cell therapies

博客

Why are Human Radiolabeled Mass-balance Studies Important in Clinical Pharmacology & Drug Development?

博客

为什么 FDA 关于循环肿瘤 DNA 的新指南对肿瘤早期临床药物开发至关重要

博客

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

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罕见病药物开发模型的实用性

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Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

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How to Fix Your Biggest Bioequivalence Mistakes

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不要忘记安全！如何在早期临床开发中评估候选药物的安全性

博客

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

博客

开发靶向共价抑制剂药物：3关键考虑因素

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临床药理学顾问的日常一天

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Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs

博客

确保抗体-药物偶联物开发最大概率获得成功的关键考虑事项

博客

开展 NASH 临床项目的开发注意事项

博客

5 Points to Consider When Designing an Immuno-oncology Clinical Pharmacology Program

博客

Rajesh Krishna, PhD

Experts Unravel the Top 5 Myths Related to Bioequivalence

10 Things You Should Consider When Planning a COVID-19 Clinical Drug Trial

Applying decision analysis to drug development for COVID-19 & future pandemics

What are biosimilars & how are they developed?

了解发现资产目标产品简介的作用

在罕见病药物研发中提高信号发现率的方法

如果你的新分子实体没有明确的药物效应，请停止！

Drug Development Considerations for Live Biotherapeutic Products

人工智能：它是什么，以及它如何加速罕见病药物开发？