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Qualitative and Quantitative Determination of Bioactive Phytochemicals in Selected Cassia Species Using HPLC-ESI-QTOF-MS and UPLC-ESI-QqQLIT-MS/MS
Published in Brijesh Kumar, Vikas Bajpai, Vikaskumar Gond, Subhashis Pal, Naibedya Chattopadhyay, Phytochemistry of Plants of Genus Cassia, 2021
Brijesh Kumar, Vikas Bajpai, Vikaskumar Gond, Subhashis Pal, Naibedya Chattopadhyay
The proposed UPLC-MRM method for quantitative analysis was validated according to the guidelines of international conference on harmonization (Guideline, I.H.T., Q2B (R1) 2005) by linearity, LOQs and LODs, precision, solution stability and recovery.
Background and Motivation
Published in Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce, Mathematical and Statistical Skills in the Biopharmaceutical Industry, 2019
Arkadiy Pitman, Oleksandr Sverdlov, L. Bruce Pearce
As the world is becoming more global, so is drug development. Clinical trials become increasingly multi-center and multi-regional. This calls for harmonization of standards that are accepted internationally. The International Conference on Harmonization (ICH), organized in Brussels in 1990, brings together representatives from health authorities and the pharmaceutical industry in Europe, Japan and the US, to harmonize technical requirements for the safety, efficacy and quality of drugs and to allow efficient drug registration.
Nonclinical Safety Evaluation of Drugs
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
Thomas M. Monticello, Jeanine L. Bussiere
The regulatory authority for pharmaceutical development and marketing approval in the United States is the US Food and Drug Administration (FDA: http://www.fda.gov); in the European Union, the European Medicines Agency (EMA: http://www.ema.europa.eu); and in Japan, the Ministry of Health, Labor, and Welfare (MHLW: http://www.mhlw.go.jp/english). These three regions work together to harmonize the nonclinical safety requirements as part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, the ICH has gradually evolved to respond to the increasingly global face of drug development. The ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. The reader is encouraged to visit these and other regulatory websites for more detailed information (http://www.ich.org).
Trend of drug clinical trials in mainland China from 2009 to 2020
Published in Current Medical Research and Opinion, 2022
Yu Cao, Lianming Liao, Xin Liu, Qingshan Zheng, Zhongyuan Xu, Haitao Niu
As economy boomed in China since 1990s, clinical research facilities were also improved4,5. China joined ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) as a full regulatory member in June 2017. The US regulators will accept data from China if they meet global quality standards. The Chinese government has funded both the National Major Scientific and Technological Special Project for New Drugs Development and the construction of GCP platforms for clinical trials continuously in the 11th, 12th, and 13th Five-Year Plans for National Economic and Social Development. Presently China is speeding up approval of innovative therapies and devices and the non-Chinese biopharmaceutical firms are benefiting from the new regulations.
High-grade glioma therapy: adding flexibility in trial design to improve patient outcomes
Published in Expert Review of Anticancer Therapy, 2022
Xiaobu Ye, Karisa C. Schreck, Byram H. Ozer, Stuart A. Grossman
There has been a continuous effort to develop guidelines for clinical research and clinical trial design methodology for more than half a century [10]. In 1990, the International Council for Harmonization (ICH) was established including representatives from the regulatory agencies and industry associations of Europe, Japan and the United States to agree upon common standard for drug development. The ICH has now published 20 guidelines directly addressing critical trial design issues such as Good Clinical Practice, general considerations for clinical trials, statistical principles for clinical trials, qualification of genomic biomarkers, genomic sampling, and concept proposals for adaptive clinical trials [11]. The respect for individual autonomy and the minimization of bias have emerged as two main principles required to ensure trial integrity, validity, and ethical conduct. It is now widely acknowledged that the inadvertent introduction of systematic error (bias) in clinical trial design and conduct can cause the results of clinical trials deviated far from the truth [12]. The guidelines provide well-established trial design procedures, such as masking, randomization, protocol compliance, and objective endpoints, to prevent erroneous trial conclusions caused by selection, recall, and physician bias as well as other factors that are associated with bias.
Patient-centered approaches for patients with systemic autoimmune rheumatic diseases: development and evolution
Published in Expert Review of Clinical Immunology, 2022
Panayiotis G Vlachoyiannopoulos, Loukas G Chatzis, Andreas V Goules, Ourania D Argyropoulou, Adamantia Englezopoulou, Ioanna Stergiou, Michalis Voulgarelis, Panayiotis Tsanakas, Themis Exarchos, Vassilis V Gorgoulis, Dimitrios I Fotiadis, Athanasios G Tzioufas
SARDs clinical diversity and genetic heterogeneity compounded by the dynamic changes at the immunologic, cellular, and molecular level point out the still unmet need for deep phenotyping of systemic autoimmune diseases [19]. The explosion of high throughput techniques, systems biology, bioinformatics, and data-driven algorithms has unleashed new information about known diseases that far exceed what is usually recorded on medical charts. To take advantage and exploit the abundance of this new information in combination with the clinical data accrued from well-designed longitudinal cohorts, it is crucial to set up international collaborations, registries, and biobanks with improved pseudo-anonymized data and biologic material that can be shared among investigators. To this end, all involved research and medical centers specializing in a given disease should harmonize their data according to the same reference model and therefore harmonization is becoming a high-quality tool. Deep phenotyping of systemic autoimmunity will enable the emergence, within each disease, of smaller but more homogenous clusters of patients who share similar features, improving follow-up and promoting tailored treatment per specific clinical phenotype or even per patient.