Understanding pharmaceutical quality by design

LX Yu, G Amidon, MA Khan, SW Hoag, J Polli… - The AAPS journal, 2014 - Springer
This review further clarifies the concept of pharmaceutical quality by design (QbD) and
describes its objectives. QbD elements include the following:(1) a quality target product …

Quality by design in pharmaceutical manufacturing: A systematic review of current status, challenges and future perspectives

HB Grangeia, C Silva, SP Simões, MS Reis - European journal of …, 2020 - Elsevier
Abstract Quality by Design (QbD) was originated in the broad domain of Quality
Management and was recently adapted and formalized in specific terms for assisting …

Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes

T De Beer, A Burggraeve, M Fonteyne… - International journal of …, 2011 - Elsevier
Within the Process Analytical Technology (PAT) framework, it is of utmost importance to
obtain critical process and formulation information during pharmaceutical processing …

Multivariate data analysis in pharmaceutics: a tutorial review

T Rajalahti, OM Kvalheim - International journal of pharmaceutics, 2011 - Elsevier
We provide an overview of latent variable methods used in pharmaceutics and integrated
with advanced characterization techniques such as vibrational spectroscopy. The basics of …

[图书][B] Pharmaceutical and medical applications of near-infrared spectroscopy

EW Ciurczak, B Igne - 2014 - books.google.com
Since the completion of the first edition of this book, major developments have occurred in
the pharmaceutical industry that have shaped the field of near-infrared (NIR) spectroscopy …

Cyber-physical-based PAT (CPbPAT) framework for Pharma 4.0

RV Barenji, Y Akdag, B Yet, L Oner - International journal of pharmaceutics, 2019 - Elsevier
Industry 4.0 aims to integrate manufacturing operations into a seamless digital whole by
incorporating flexibility, agility, re-configurability, and sustainability. The result of this …

Estimation of active pharmaceutical ingredients content using locally weighted partial least squares and statistical wavelength selection

S Kim, M Kano, H Nakagawa, S Hasebe - International journal of …, 2011 - Elsevier
Development of quality estimation models using near infrared spectroscopy (NIRS) and
multivariate analysis has been accelerated as a process analytical technology (PAT) tool in …

Discrimination of substandard and falsified formulations from genuine pharmaceuticals using NIR spectra and machine learning

O Awotunde, N Roseboom, J Cai, K Hayes… - Analytical …, 2022 - ACS Publications
Near-infrared (NIR) spectroscopy is a promising technique for field identification of
substandard and falsified drugs because it is portable, rapid, nondestructive, and can …

Critical review of near-infrared spectroscopic methods validations in pharmaceutical applications

C De Bleye, PF Chavez, J Mantanus, R Marini… - … of pharmaceutical and …, 2012 - Elsevier
Based on the large number of publications reported over the past five years, near-infrared
spectroscopy (NIRS) is more and more considered an attractive and promising analytical …

Predicting feeder performance based on material flow properties

Y Wang, T Li, FJ Muzzio, BJ Glasser - Powder Technology, 2017 - Elsevier
Purpose Accurate and consistent delivery of materials by well-designed feeders ensures
overall process stability. Importantly, feeding performance is strongly dependent on material …