First-in-human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines. These trials allow sponsors to determine potential risks associated to the drug at each step of its development, and determine the safe dose range in the course of its clinical progression.

Click here to download a PDF, readable version of Issue 10: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue10_FIH_2022.pdf

CHAPTERS:

- 0:14 — Section 1: Introduction

- 2:16 — Section 2: Designing a Successful FIH Trial

- 5:57 — Section 3: Bridging the Gap from Preclinical to Clinical

- 8:19 — Section 4: Access to Patient Populations

- 9:26 — Section 5: Integrating Adaptive Designs in FIH Trials

- 15:26 — Section 6: Case Study

- 18:38 — Section 7: Choosing the Right CRO

About Altasciences:

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.