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ISSN: 2574 -1241
ISSN: 2574 -1241
Received: August 21, 2018; Published: August 29, 2018
DOI: 10.26717/BJSTR.2018.08.001662
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.
Abstract | Introduction | Conclusion | References |
International Association of Landscape Archaeology, Czech Glass Society, Czech Republic
Department of Chemistry, Semenov Institute of Chemical Physics, USSR Academy of Sciences, Moscow, Russia
Department of Educational Sciences, Research Centre Qualities of Teachers, School of Education – HAN, Nijmegen, Netherlands
Associate Professor at Department of Breast and Thyorid Surgey, Chongqing General Hospital, China
Neurology, LA BioMed Research Institute, USA
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