Discovery of quality control markers from traditional Chinese medicines by fingerprint-efficacy modeling: Current status and future perspectives
C Zhang, X Zheng, H Ni, P Li, HJ Li - Journal of Pharmaceutical and …, 2018 - Elsevier
Quality control (QC) is crucial for ensuring the safety and effectiveness of traditional Chinese
medicines (TCMs). Due to extremely complicated phytochemical matrices and characteristic …
medicines (TCMs). Due to extremely complicated phytochemical matrices and characteristic …
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration
BM Davit, ML Chen, DP Conner, SH Haidar, S Kim… - The AAPS journal, 2012 - Springer
Highly variable (HV) drugs are defined as those for which within-subject variability (% CV) in
bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies …
bioequivalence (BE) measures is 30% or greater. Because of this high variability, studies …
[HTML][HTML] Bioactive equivalence of combinatorial components identified in screening of an herbal medicine
P Liu, H Yang, F Long, HP Hao, X Xu, Y Liu… - Pharmaceutical …, 2014 - Springer
Purpose To identify bioactive equivalent combinatorial components (BECCs) in herbal
medicines. The exact composition of effective components in herbal medicines is often …
medicines. The exact composition of effective components in herbal medicines is often …
Multi-parametric cellular imaging coupled with multi-component quantitative profiling for screening of hepatotoxic equivalent markers from Psoraleae Fructus
C Zhang, DD Qian, T Yu, H Yang, P Li, HJ Li - Phytomedicine, 2021 - Elsevier
Abstract Background The hepatotoxicity of Chinese herbal medicine (CHM) is an important
reason for its restrictive application. Psoraleae Fructus (PF), a commonly used CHM for …
reason for its restrictive application. Psoraleae Fructus (PF), a commonly used CHM for …
Innovative approaches for demonstration of bioequivalence: the US FDA perspective
X Zhang, N Zheng, RA Lionberger, LX Yu - Therapeutic Delivery, 2013 - Taylor & Francis
In this article, the authors will briefly introduce the general concepts and background of
bioavailability and bioequivalence (BE), discuss the conventional method for BE …
bioavailability and bioequivalence (BE), discuss the conventional method for BE …
[HTML][HTML] Discovery of Hepatotoxic Equivalent Combinatorial Markers from Dioscorea bulbifera tuber by Fingerprint-Toxicity Relationship Modeling
W Shi, C Zhang, D Zhao, L Wang, P Li, H Li - Scientific Reports, 2018 - nature.com
Due to extremely chemical complexity, identification of potential toxicity-related constituents
from an herbal medicine (HM) still remains challenging. Traditional toxicity-guided …
from an herbal medicine (HM) still remains challenging. Traditional toxicity-guided …
The revised 2010 EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action
RK Verbeeck, FM Tshinanu - Journal of Pharmacy …, 2012 - researchportal.unamur.be
Abstract On August 1, 2010, a revised guidance regarding bioequivalence (BE) assessment
for the approval of innovator (bridging studies, variations, line extensions) and generic …
for the approval of innovator (bridging studies, variations, line extensions) and generic …
[HTML][HTML] A phase I, randomized, single-dose study to evaluate the biosimilarity of QL1206 to denosumab among Chinese healthy subjects
H Zhang, M Wu, X Zhu, C Li, X Li, J Sun… - Frontiers in …, 2020 - frontiersin.org
Objective This study was conducted to explore the tolerance, variability, pharmacokinetics
(PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese …
(PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese …
[HTML][HTML] Association of variability and pharmacogenomics with bioequivalence of gefitinib in healthy male subjects
H Zhang, Q Li, X Zhu, M Wu, C Li, X Li, C Liu… - Frontiers in …, 2018 - frontiersin.org
Objective: The aim of the study was to explore the association of pharmacokinetic variability
and pharmacogenomics with the bioequivalence of orally administered gefitinib (Iressa® …
and pharmacogenomics with the bioequivalence of orally administered gefitinib (Iressa® …
Consumer's risk in the EMA and FDA regulatory approaches for bioequivalence in highly variable drugs
The 2010 US Food and Drug Administration and European Medicines Agency regulatory
approaches to establish bioequivalence in highly variable drugs are both based on linearly …
approaches to establish bioequivalence in highly variable drugs are both based on linearly …