Abstract
Practical Considerations in #Pharmaceutical Production Scale-Up- This
paper is meant to provide a high-level overview of the steps required to
prepare the bulk drug substance API. From first-in-human and through
each of the clinical trial stages and into commercialization, scale-up
of formulation design is a natural part of pharmaceutical development.
At each stage of process development, the batch size increases, from
laboratory- scale batches that may be quite small to support #preclinical
and early clinical stages, to pilot batches that are used in process
development, and finally to the production-scale batches needed to
support commercialization. Since phase 1 studies are generally first in human studies, they are the
initial baseline for establishing the safety of the product in people.
Because changes to product quality could affect patient safety, this
paper focused on establishing a controlled manufacturing process and a
set of analytical assays to detect any changes to the product which
could potentially impact #patient safety [1]. In addition, a specific set
of studies have also been discussed that also help to ensure patient
safety during the phase 1 clinical trial.
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Considerations for Successful Scale-Up to Tox Batches and Phase-Api (Bulk Drug substance) by Krishnasarma pathy in BJSTR
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