Articles & Research from Venn Life Sciences

CMC regulatory team capabilities

For 20+ years, members of the CMC regulatory team supported several (bio)pharmaceutical companies to ensure manufacture of safe, effective, and high-quality drug products for patients globally

Strategies for Non-clinical safety assessment of vaccines

Setting the scene Over the past century, vaccines have made a large impact on public health, as recently demonstrated by the treatment of the worldwide Covid-pandemic. Since, in general, vaccines are administered to healthy individuals, including infants and children, it is important to demonstrate the...

Clinical PK and PD Service at Venn Breda

For more than 20 years, the clinical pharmacokinetic (PK: understanding the kinetics of a drug in terms of absorption, distribution, metabolism and elimination [ADME]) and pharmacodynamic (PD: the biochemical andphysiological effects of a drug) team of Venn Life Sciences have supported (model-independent) noncompartmental (NCA) PK...

The Drug development plan – Your roadmap to success

Each journey begins at a starting point, and we believe that few journeys are as exciting as developing a drug. In order to succeed and reach your destination, you need a solid roadmap, the drug development plan (DDP), this is the outline of your drug...

Safe starting dose in a First-in-Human trial: When & How to Prepare?

The first‐in‐human (FIH) clinical trial is an important milestone for each development program. For small (bio)pharma companies the FIH trial requires a significant investment, and every sponsor wants to make sure that all is well set for starting the trial. It is indisputable that successful...

Methodology & Statistics in Clinical Research: Do you want to know more?

Did you ever ask yourself one of the following questions?: “…a significant difference (p=0.002) was observed between the two groups…” What does this mean? What exactly is a p-value and what does it tell me? What is the difference between an independent 2-samples t-test and...

BioTech News & Life Sciences Article – Drug Development Plan – English Version

BiotechNEWS & Life Sciences Article - Drug Development Plan - Dutch Version

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