Clinical Pharmacology Archives

Case Study

Dose Optimization Using Population PK for an Orphan Drug

RAPALIMUS® Tablets (sirolimus) is Nobelpharma’s orphan drug developed from an oral medication that is sold…

CertaraNovember 17, 2021

Blog

A Day in the Life of a Clinical Pharmacology Consultant

Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike…

CertaraOctober 8, 2021

Blog

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

Alzheimer's disease (AD) is one of the most common forms of neurodegenerative dementia in the…

CertaraSeptember 20, 2021

On-Demand Webinar

What does the Clinical Pharmacology Plan for a Biologic Look Like?

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…

CertaraAugust 6, 2021

Blog

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

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…

CertaraJuly 8, 2021

Blog

8 Tips for Successfully Developing Oligonucleotide Therapies

By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of…

CertaraFebruary 1, 2021

White Paper

“Where do I start?”: Strategies for selecting the first dose for human clinical trials

This guide to dose selection for first-in-human studies explains the conceptual framework, methods, and tools…

CertaraDecember 22, 2020

Blog

Clinical Pharmacology Gap Analysis: Lessons Learned

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these…

CertaraAugust 10, 2018

Publication

Metformin Treatment of Type 2 Diabetes Mellitus in Pregnancy: Update on Safety and Efficacy

CertaraApril 25, 2018

Blog

Using M&S to Evaluate Oncology Drug Dosing

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which…

CertaraApril 13, 2018

Clinical Pharmacology

Dose Optimization Using Population PK for an Orphan Drug

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

What does the Clinical Pharmacology Plan for a Biologic Look Like?

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

8 Tips for Successfully Developing Oligonucleotide Therapies

“Where do I start?”: Strategies for selecting the first dose for human clinical trials

Clinical Pharmacology Gap Analysis: Lessons Learned

Metformin Treatment of Type 2 Diabetes Mellitus in Pregnancy: Update on Safety and Efficacy

Using M&S to Evaluate Oncology Drug Dosing

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