Clinical Trials
Quiz – All About Investigational New Drug Submission
Test Your Knowledge —Investigational New Drugs
If you work in, or around, the early phase drug development landscape, you are likely aware of the requirements for an investigational new drug (IND) package.
Renal Impairment Study Designs Trends, Optimization, Adaptive Approach. A Review.
Drug-Drug Interactions - What you Should Know
the study of Drug-Drug Interactions
ISSUE NO. 10 — Tackling Early-Phase Development Challenges with Effective First-in-Human Studies
First-in-Human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines. Their purpose is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans.
They may also include the collection of data on food or drug interactions, different age groups or gender, proof of concept, and relative bioavailability of different formulations.
In Issue 10 of The Altascientist, we review:
- Designing a FIH trial
- Key aspects of FIH trial designs
- Access to patient populations
- Integrating adaptive designs into FIH trials
- A single-center, randomized, placebo-controlled, double-blind, adaptive, FIH study case study
Clinical Case Study - First in Human
Clinical Case Study - Randomized Cross Over Efficacy Study Metabolic Disorder
Clinical Case Study - Evaluting Abuse Potential (HAP) neuropathic pain medication
Clinical Case Study - Drug-Drug Interactions (DDI) Cardiovascular Medication
Clinical Case Study - FIH Safety and Tolerability Cannabis Extract
Clinical Case Study - 505(b)(2) Regulatory Approval, Multiple NDA-enabling Studies