Clinical Pharmacology Archives

On-Demand Webinar

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to…

CertaraNovember 19, 2021

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

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

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

Blog

Using a Pharmacology to Payer Framework to Support Product Development

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains…

CertaraMarch 16, 2018

Clinical Pharmacology

Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

Dose Optimization Using Population PK for an Orphan Drug

A Day in the Life of a Clinical Pharmacology Consultant

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

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

Using M&S to Evaluate Oncology Drug Dosing

Using a Pharmacology to Payer Framework to Support Product Development

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