홈 / 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. With ~25 years of combined pharmaceutical industry and consulting experience, he has contributed to over 40 INDs; over 200 Phase 1/1b studies; and to several NDAs/BLAs. He is an author of Raj’s clinical pharmacology blogs.

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

Methods to Increase Signal Finding in Rare Disease Drug Development

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

Drug Development Considerations for Live Biotherapeutic Products

Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

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

The Utility of Model-Informed Drug Development for Rare Diseases

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

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

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

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Development considerations for pioneering a NASH clinical program

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