Application Note

Advancing Your API To First Human Dose Trials Quicker, Cheaper, And More Efficiently

By Ed Groleau, Director, Clinical Supply Chain for North America, PCI Pharma Services


PCI Pharma Services has launched a new service called SMART First Human Dose (FHD) to accelerate early phase clinical manufacture and supply. This service combines three of PCI's flagship services: drug-in-capsule manufacture using Xcelodose micro-dosing technology, clinical packaging services, and clinical program management service called clinicalSMART. By using Xcelodose, the first-in-human dose can be delivered to the clinic faster by eliminating the need for pre-formulation activities and stability studies. The clinical packaging services include a new highly potent packaging facility that ensures operator safety and drug product integrity. The clinicalSMART service provides support for clinical drug supply management throughout the study lifecycle, offering flexibility and expertise to develop optimal supply strategies. The goal of SMART FHD is to provide a seamless and efficient process for getting valuable APIs to Phase I clinical trials.

PCI's SMART FHD service combines their clinicalSMART team's expertise with their ability to manufacture dosage forms and their clinical packaging network to rapidly transition a drug product from candidate selection to first human dose clinical trials. This service reduces the time to market by several months and offers benefits such as rapid access to clinical data, financial savings, and flexibility of supply. Learn how by offering end-to-end support for drug development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging, PCI Pharma Services aims to help pharmaceutical companies accelerate the development of new drugs and bring them to market faster.

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