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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.

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

7 Frequently asked Questions on Clinical Study Design

Statistical Consultancy Team

Quanticate has released several white papers around Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies. Our statistical consultancy team was pleased to receive feedback and questions from our clients and piers on these papers which we would like to share with you all below.

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Topics: Bayesian Statistics, Bayesian Study Design, Bayesian Methods, Phase I Studies, Clinical Study Design, Interim Analysis, Biostatistics Consulting, Phase I Study Design

Biomarkers in Drug Development

Statistical Consultancy Team

The identification of novel and effective biomarkers in drug development is considered a key feature in the optimization of the drug development process. But what exactly is a biomarker? As defined by Grutolla et al. [1], a biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Examples include concentrations of particular proteins in the blood or bone marrow, liver function tests or PET imaging as indicators of disease state or therapeutic benefit.

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Topics: Bayesian Study Design, Phase I Studies, Biomarkers, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design, Drug Development

Economical Designs for Phase I Studies

Statistical Consultancy Team
The objectives of the Phase I development plan are many. Alongside establishing the safety, tolerability and pharmacokinetics (PK) of single and multiple doses in humans and ascertaining the maximum tolerated dose, it is often important to explore at least some of the following:
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Topics: Statistical Programming, Pharmacokinetics and Pharmacodynamic, Phase I Studies, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design

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