Considerations for Successful Scale-Up To Tox Batches And Phase-Api (Bulk Drugsubstance)

Volume 1 - Issue 3

Krishna Sarma Pathy*

Received: August 17, 2018;   Published: August 28, 2018

DOI: 10.32474/LOJMS.2018.01.000112

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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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