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Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving…

Certara2019 年 2 月 22 日

White Paper

PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is…

Certara2019 年 2 月 4 日

Poster

Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin

Certara2018 年 11 月 4 日

Blog

7 Things to Know About the China Pharmaceutical Industry

China is the second largest pharmaceutical market in the world. Demand is likely to increase…

Certara2018 年 10 月 16 日

Poster

Development of a Pre-clinical Quantitative Systems Pharmacology Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy

Certara2018 年 10 月 8 日

Blog

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…

Certara2018 年 9 月 27 日

On-Demand Webinar

How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs

Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin…

Certara2018 年 9 月 25 日

Brochure

Certara 专业认证计划

Certara Professional Certification is an online accreditation of user competency and proficiency in analysis of…

Certara2018 年 8 月 21 日

Publication

Precision Dosing in Clinical Medicine: Present and Future

Certara2018 年 7 月 20 日

On-Demand Webinar

Using IVIVC to Optimize Your Drug Formulation After a Failed BA/BE Study

This webinar introduced how IVIVC can be used to get your drug program back on…

Certara2018 年 7 月 18 日

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Managing Immunogenicity Using Quantitative Systems Pharmacology

PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin

7 Things to Know About the China Pharmaceutical Industry

Development of a Pre-clinical Quantitative Systems Pharmacology Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy

FDA’s New ANDA Submissions Guidance: Key Points

How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs

Certara 专业认证计划

Precision Dosing in Clinical Medicine: Present and Future

Using IVIVC to Optimize Your Drug Formulation After a Failed BA/BE Study

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