ホーム / Author / Rajesh Krishna, PhD

Rajesh Krishna, PhD

Distinguished Scientist, Drug Development Science

Rajesh Krishna, PhDは、サターラ・ストラテジック・コンサルティングの医薬品開発科学特別研究員、ならびに希少疾患に関する統合プラクティス領域のリーダーです。医薬品業界とコンサルティングを合わせて約25年の経験を有し、40件以上の治験薬、200件以上の第1/1b相試験、および数件の新薬申請（new drug application、NDA）/生物製剤承認申請（biologicslicense application、BLA）に貢献してきました。Rajの臨床薬理ブログの執筆者でもあります。

Authored by Rajesh Krishna, PhD

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?

Understanding the Role of Your Discovery Asset’s Target Product Profile

希少疾患治療薬開発におけるシグナル検出を増加させる方法

Stop if you don’t have an unambiguous drug effect for your new molecular entity!

Drug Development Considerations for Live Biotherapeutic Products

人工知能：希少疾病治療薬の開発を加速させる方法とは？

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

Why you should select your drug formulation before starting clinical studies

Key development considerations for cell therapies

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

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

希少疾患に対するモデルを活かした医薬品開発（MIDD）の有用性

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

How to Fix Your Biggest Bioequivalence Mistakes

Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

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

標的共有結合阻害薬の開発：3つの検討事項

A Day in the Life of a Clinical Pharmacology Consultant

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

抗体薬物複合体開発の成功の確率を最大化するための主な検討事項

NASH臨床プログラムを開拓するための開発上の留意点

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