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. 2025 May 8;17(5):623. doi: 10.3390/pharmaceutics17050623
QbD Quality by Design
CQAs Critical Quality Attributes
TPQP Target Product Quality Profile
DoE Design of Experiments
PAT Process Analytical Technology
QC Quality Control
HPLC High-Performance Liquid Chromatography
CPPs Process Parameters
ICH International Council for Harmonisation
CMAs Critical Material Attributes
FMEA Failure Mode and Effects Analysis
QMS Quality Management Systems
PROs Patient-Reported Outcomes
RWE Real-World Evidence
PFDD Patient-Focused Drug Development
IVIVC In Vitro-in Vivo Correlations
NIR Near-Infrared Spectroscopy
ADCC Alter antibody-Dependent Cellular Cytotoxicity
HCP Host Cell Protein
SEC Size Exclusion Chromatography
CE Capillary Electrophoresis
PLS Partial Least Squares
RSM Response Surface Methodology
MVA Multivariate Analysis
PCA Principal Component Analysis
RTRT Real-Time Release Testing
MPC Model Predictive Control
CCPs Critical Control Points
ANNs Artificial Neural Networks
DNNs Deep Neural Networks
RL Reinforcement learning
PSD Particle Size Distribution
CM Continuous Manufacturing
OOS Out-of-Specification
CHO Chinese Hamster Ovary
MOI Multiplicity of Infection
HA Hemagglutinin
ATMPs Advanced Therapy Medicinal Products
SLS Selective Laser Sintering
FDM Fused Deposition Modeling
BCS Biopharmaceutics Classification System