CALL US +44 (0)1462 440 084 | +1 919-882-2016 | Contact | Submit RFI

Methods for assessing early-phase equivalence in Biosimilars

Statistical Consultancy Team

Rheumatoid Arthritis (RA) is a long-term inflammatory disease that causes pain, swelling, 
stiffness and loss of function in joints, with an approximately 0.5 to 1% (and increasing) prevalence in adults worldwide.  Alongside many treatment options, 
there’s recently been an increased focus on producing biosimilars, with many new drugs expected to come to the market in the coming years [1]. 

Read More
Topics: Phase I Studies, Biostatistics Consulting, Bioequivalence, Biosimilars, Bioavailability, Rheumatoid Arthritis (RA)

A Guide to Phase 1 Clinical Trial Designs

Statistical Consultancy Team

The primary aims of Phase 1 clinical trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound.  Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.

Read More
Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Phase I Study Design, Clinical Trial Phases, Phase 3 Studies, Peadiatric Assessments, Bioequivalence, Drug-drug Interaction, Bioavailability

Welcome to The Quanticate Blog

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

Subscribe to Email Updates

Blog Suggestions

Most Read

Posts by Topic

Expand all