Mini ReviewOpen Access

Considerations for Successful Scale-Up to Tox Batches and Phase-Api (Bulk Drug substance)

Volume 8 - Issue 3

Krishnasarma pathy*

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- Head /QC/QAIPL Research Centre, Editoral Board Member- Associate Editor, India
*Corresponding author: krishnasarma pathy, Head /QC/QAIPL research centre, Editoral Board Member- Associate Editor, India

Received: August 21, 2018; Published: August 29, 2018

DOI: 10.26717/BJSTR.2018.08.001662

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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.

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