Federal regulations and policies require institutions to establish procedures for ongoing IACUC oversight of approved animal care and use program activities including animal procedures. To fulfill these requirements, research institutions implement postapproval monitoring (PAM) programs designed to assure compliance in animal activities. Although several references commenting on the requirement to conduct PAM are available, few publications discuss actual best practices for accomplishing PAM. Here we use information collected through a survey of large academic research institutions to identify common practices for conducting PAM reviews. Many similarities and differences exist between institutions, which may or may not influence the overall quality of an institution's PAM program.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6643091 | PMC |
http://dx.doi.org/10.30802/AALAS-JAALAS-18-000132 | DOI Listing |
Anal Chem
December 2024
AbbVie, Inc., North Chicago, Illinois 60064, United States.
This paper explores the current analytical method validation practices, mainly derived from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines (2005) and presents a strategy for adopting the latest guidelines for analytical chemistry in the pharmaceutical industry (ICH Q14/Q2(R2), USP ⟨1220⟩). These documents emphasize a lifecycle approach to method development, qualification, and validation, aligning with the holistic, risk-based control strategy central to future submission dossier structures. Key elements of the enhanced approach described in ICH Q14, including Analytical Target Profile (ATP), Knowledge Management, Analytical Risk Assessment, and Performance Monitoring, are discussed and integrated into a clear Analytical Quality by Design (AQbD) framework for analytical procedure development and lifecycle management.
View Article and Find Full Text PDFVaccine
December 2024
Food and Drugs Authority, P. O. Box CT 2783 Accra, Ghana; PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy, University of Groningen, the Netherlands. Electronic address:
Introduction: The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.
View Article and Find Full Text PDFPediatr Dermatol
November 2024
Department of Dermatology and Cutaneous Biology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Janus kinase inhibitors (JAKi) are drugs that block tyrosine kinases responsible for transducing cytokine signals. The first JAKi was approved by the US Food and Drug Administration (FDA) in 2011 to treat rheumatoid arthritis in adults. A pediatric indication was not approved until 8 years later, for acute graft-versus-host disease.
View Article and Find Full Text PDFClin Pharmacol Ther
December 2024
Department of Clinical Pharmacy, College of Pharmacy, Daegu Catholic University, Gyeongsan, Korea.
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) oversee pharmaceutical regulations, including orphan drugs targeting rare diseases with limited patient populations.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!