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Now showing items 11-15 of 15
Common defciencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)
(Springer Nature, 2022)
The aim of the study was to investigate the common defciencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted
retrospectively ...
Structural analysis, molecular modelling and preliminary competition bnding studies of AM-DAN as a NMDA Receptor PCP-Site Fluorescent Ligand
(MDPI, 2019)
Excitotoxicity related to the dysfunction of the N-methyl-d-aspartate receptor (NMDAR)
has been indicated to play an integral role in the pathophysiology of multiple disease states, including
neurodegenerative disorders ...
The implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA)
(Springer, 2023)
An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South
African Health Products Regulatory Authority (SAHPRA) inherited from the Medicine Control Council (MCC). Revising ...
Common Deficiencies Found in the Active Pharmaceutical Ingredient (API) Section of Non-sterile Generic Products Submitted for Registration by SAHPRA
(Springer Science and Business Media Deutschland GmbH, 2023)
Purpose: This research study aims to determine the qualitative and quantitative common deficiencies included in the API section of dossiers submitted to SAHPRA. The study was conducted retrospectively over a 7-year period ...
Regulatory registration timelines of generic medicines in South Africa: Assessment of the performance of SAHPRA between 2011 and 2022
(Springer, 2023)
Various regulatory authorities are experiencing backlogs of applications which result in delayed access
to medicines for patients. The objective of this study is to critically assess the registration process utilised by ...