Pharmaceutical 'New Prior Knowledge': Twenty-First Century Assurance of Therapeutic Equivalence
| Autor: | Ajaz S. Hussain, Vadim J. Gurvich, Kenneth R. Morris |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Knowledge management
generic drug prices Computer science media_common.quotation_subject levothyroxine Pharmaceutical Science White Paper 02 engineering and technology Aquatic Science Public domain 030226 pharmacology & pharmacy Trade secret Domain (software engineering) 03 medical and health sciences 0302 clinical medicine Drug Development Drug Discovery Drugs Generic Humans Quality (business) Biosimilar Pharmaceuticals Ecology Evolution Behavior and Systematics Administration Intranasal New drug application media_common Operationalization Ecology business.industry Biosimilar enoxaparin General Medicine 021001 nanoscience & nanotechnology mometasone furoate Thyroxine Drug development Pharmaceutical Preparations Therapeutic Equivalency 0210 nano-technology business new prior knowledge Agronomy and Crop Science |
| Zdroj: | AAPS PharmSciTech |
| ISSN: | 1530-9932 |
| Popis: | Facilitating utility of prior knowledge to accelerate evidence-based new drug development is a focus of several communities of knowledge, such as clinical pharmacology. For example, progress has been made via modeling and simulation of pharmacokinetic and pharmacodynamic relationships in the more effective use of “End of Phase 2” regulatory meetings for a New Drug Application (NDA). Facilitating utility of prior “Chemistry, Manufacturing, and Controls” (CMC) knowledge to accelerate new drug development and regulatory review process is also a topic of significant interest. This paper focuses on facilitating the utility of prior pharmaceutical formulation knowledge to accelerate drug product development and regulatory review of generic and biosimilar products. This knowledge is described as New Prior Knowledge (NPK) because research is often needed to fill ontological (i.e., the domain of connectivity between concepts and phenomena), epistemological (i.e., distinguishing knowledge or justified belief from the opinion), and methodological gaps in information derived a decade or so ago. The corporate economic advantages of such knowledge are derived, in part, when significant portions remain a trade secret. The proposed NPK seeks to generate knowledge about critical aspects of pharmaceutical quality and failure modes to place it in the public domain and to facilitate accelerated and more confident development and regulatory review of generic products. The paradoxical combination of “new” and “prior knowledge” is chosen deliberately to highlight both a distinction from proprietary and trade secret information and to acknowledge certain historical dogmas inherent in the current practices. Considerations for operationalizing NPK are also summarized. |
| Databáze: | OpenAIRE |
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