Time Series, Health & Evidence Synthesis · Clinical Research & Protocols

Clinical Research: Introduction and Development of Drugs

Public introduction · full guide in Eikos

Introduction

What this guide covers

A comprehensive, graduate-level treatise on the biostatistical methodology, pharmacokinetic foundations, and clinical trial designs that govern contemporary scientific discovery.

Overview

Topics covered

  • Introduction
  • The Global Drug Development Process and its Design Philosophy
  • Phase I Clinical Trials: Tolerability, Pharmacokinetics and Pharmacodynamics
  • Fundamentals of Pharmacokinetic Modeling (PK)
  • Dose Escalation Design and Bayesian Inference
  • Phase II Clinical Trials: Proof of Concept and Multistage Designs

Related concepts

Main connections

  • Survival analysis & Kaplan-Meier
  • Clinical trials & RCT design
  • Variance & standard deviation
  • Maximum likelihood estimation
  • Bayes' theorem & priors
  • Hypothesis testing

Compatible notation

Mathematical sample in LaTeX

The expression is rendered accessibly, with its LaTeX source preserved below.

HED (human equivalent dose)=NOAELanimal×(PesoanimalPesohumano)1−b
View LaTeX source\text{HED (human equivalent dose)} = \text{NOAEL}_{\text{animal}} \times \left( \frac{\text{Peso}_{\text{animal}}}{\text{Peso}_{\text{humano}}} \right)^{1 - b}