Drug Development and Label Optimization Using Proven Biosimulation Methodology

The Food and Drug Administration (FDA) or other regulatory body-approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for clinicians and patients. For drug companies, the label is the culmination of years of work and millions, if not billions of dollars.

Spotlight

Nitto Avecia

Nitto Avecia is the largest oligonucleotide manufacturer in the world and continues to play an integral role in advancing the oligo therapeutic market.

OTHER WHITEPAPERS
news image

QbD and PAT in Biopharmaceutical Development

whitePaper | July 12, 2022

As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA ’s process validation (PV) guidance (1) and International Conference on Harmonization.

Read More
news image

Addressing Viral Pandemics Such as COVID-19 Using the Carterra® LSA

whitePaper | January 21, 2023

Emerging Diseases Require New Tools Medicines to treat and prevent infectious diseases cover a broad range of modalities from dosed therapeutics to vaccines. Biotherapeutics require a detailed knowledge of binding sites, or epitopes, on their respective antigens.

Read More
news image

Global Use of Medicines 2023

whitePaper | January 18, 2023

Reaching a post-pandemic era is an alluring prospect for almost everyone around the world after the disruptions of the past three years.

Read More
news image

Understanding the true cost of transparency reporting

whitePaper | December 14, 2022

When the regulatory hammer came down on pharmaceutical and life sciences (PLS) companies in the 2010s, it introduced new complexities for these businesses.

Read More
news image

Application Notes & Whitepapers 2019

whitePaper | December 19, 2019

Welcome to European Pharmaceutical Review’s Application Notes & Whitepapers Supplement 2019. This year’s topics range from analytical techniques for bioprocess investigation, host cell protein analysis and Raman imaging to advice on outsourcing services for product characterisation.

Read More
news image

MOLECULAR GLUES LANDSCAPE IN DRUG DISCOVERY

whitePaper | June 21, 2022

nduced-proximity targeted protein degradation (TPD) is a ground-breaking strategy in drug discovery that has emerged during the last decade.

Read More

Spotlight

Nitto Avecia

Nitto Avecia is the largest oligonucleotide manufacturer in the world and continues to play an integral role in advancing the oligo therapeutic market.

Events