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The Apple Polyphenol Phloretin Inhibits Breast Cancer Cell Migration And Proliferation Via Inhibition Of Signals By Type 2 Glucose Transporter, K.-H. Wu, C.-T. Ho, Z.-F. Chen, L.-C. Chen, J. Whang-Peng, T.-N. Lin, Y.-S. Ho 2020 Taiwan Food and Drug Administration

The Apple Polyphenol Phloretin Inhibits Breast Cancer Cell Migration And Proliferation Via Inhibition Of Signals By Type 2 Glucose Transporter, K.-H. Wu, C.-T. Ho, Z.-F. Chen, L.-C. Chen, J. Whang-Peng, T.-N. Lin, Y.-S. Ho

Journal of Food and Drug Analysis

Human triple-negative breast cancer (TNBC) is the most aggressive and poorly understood subclass of breast cancer. Glucose transporters (GLUTs) are required for glucose uptake in malignant cancer cells and are ideal targets for cancer therapy. To determine whether the inhibition of GLUTs could be used in TNBC cell therapy, the apple polyphenol phloretin (Ph) was used as a specific antagonist of GLUT2 protein function in human TNBC cells. Interestingly, we found that Ph (10–150 μM, for 24 h) inhibited cell growth and arrested the cell cycle in MDA-MB-231 cells in a p53 mutant-dependent manner, which was confirmed by pre-treatment of …


The Inhibition Of Advanced Glycation End-Products By Five Fractions And Three Main Flavonoids From Camellia Nitidissima Chi Flowers, R. Yang, W.-X. Wang, H.-J. Chen, Z.-C. He, A.-Q. Jia 2020 Taiwan Food and Drug Administration

The Inhibition Of Advanced Glycation End-Products By Five Fractions And Three Main Flavonoids From Camellia Nitidissima Chi Flowers, R. Yang, W.-X. Wang, H.-J. Chen, Z.-C. He, A.-Q. Jia

Journal of Food and Drug Analysis

Camellia nitidissima Chi (CNC), belonging to Camellia genus (Theaceae family), is a medicinal and edible plant in China. Among the whole plant, the CNC flowers are especially precious, but the biological activities and the compositions of the CNC flowers are unknown. In this study, inhibiting effects on the formation of advanced glycation end-products (AGEs) of five CNC flowers fractions and three isolated compounds were investigated, these three compounds are two flavonoid glycosides and one flavanol, namely kaempferol 3-O-[2,3,4-Tri-O-acetyl-α-L-rhamnopyranosyl-(1→3)-2,4-di-O-acetyl-α-L-rhamnopyranosyl-(1→6)]-β-D-glucopyranoside, kaempferol 3-O-[2,3,4-Tri-O-acetyl-α-L-rhamnopyranosyl-(1→3)-4-O-acetyl-α-L-rhamnopyranosyl-(1→6)]-β-D-glucopyranoside and catechin. Among these five fractions, the ethyl acetate fraction showed the highest total phenolic contents and inhibiting effects on …


Application Of Corona Electrical Discharge Plasma On Modifying The Physicochemical Properties Of Banana Starch Indigenous To Taiwan, T.-Y. Wu, N.-N. Sun, C.-F. Chau 2020 Taiwan Food and Drug Administration

Application Of Corona Electrical Discharge Plasma On Modifying The Physicochemical Properties Of Banana Starch Indigenous To Taiwan, T.-Y. Wu, N.-N. Sun, C.-F. Chau

Journal of Food and Drug Analysis

Corona electrical discharge (CED) belongs to an atmospheric pressure cold plasma. In this study, raw banana starch (indigenous to Taiwan), which contained resistant starch and amylose at a level of 58.4 g/100 g and 14.5 g/100 g, respectively, was treated by CED at 30 kV/cm, 40 kV/cm, and 50 kV/cm for 3 minutes. After the CED treatment, starch analyses showed that there were no apparent changes in the resistant starch and amylose contents. Only surface and nonpenetrative damage caused by plasma etching at different voltage strengths were observed on the starch granules. The CED treatments reduced the total area of …


Metabolic Profiling Investigation Of Fritillaria Thunbergii Miq. By Gas Chromatography–Mass Spectrometry, M.-C. Cui, S.-J. Chen, H.-H. Wang, Z.-H. Li, H.-J. Chen, Y. Chen, H.-B. Zhou, X. Li, J.-W. Chen 2020 Taiwan Food and Drug Administration

Metabolic Profiling Investigation Of Fritillaria Thunbergii Miq. By Gas Chromatography–Mass Spectrometry, M.-C. Cui, S.-J. Chen, H.-H. Wang, Z.-H. Li, H.-J. Chen, Y. Chen, H.-B. Zhou, X. Li, J.-W. Chen

Journal of Food and Drug Analysis

Thunberg fritillary bulb (the dry bulbs of Fritillaria thunbergii Miq.), a traditional Chinese Medicine, is widely applied as an expectorant and antitussive. In this investigation, the primary metabolites of bulbs, flowers, leaves, and stems of F. thunbergii were analyzed by gas chromatography–mass spectrometry. Principal component analysis, partial least squares-discriminate analysis, orthogonal projection to latent structures-discriminate analysis, and heat map analysis showed that there were dissimilar metabolites, and a negative correlation between amino acids and saccharides in different analytes. Furthermore, carbodiimide, tryptophan, glucose-6-phosphate, xylose, 2-piperidinecarboxylic acid, monoamidomalonic acid, phenylalanine, and histidine were found to play an important role in the plant …


Simultaneous Determination Of Four Amides In Saururus Chinensis By Matrix Solid Phase Dispersion And High-Performance Liquid Chromatography Method, H. Chen, J. Liu, M. Cui, J. Chen, X. Li, Y. Chen 2020 Taiwan Food and Drug Administration

Simultaneous Determination Of Four Amides In Saururus Chinensis By Matrix Solid Phase Dispersion And High-Performance Liquid Chromatography Method, H. Chen, J. Liu, M. Cui, J. Chen, X. Li, Y. Chen

Journal of Food and Drug Analysis

A rapid and simple analytical method was established for the determination of four amides (N-p-trans-coumaroyltyramine, aristolactam AⅡ, sauristolactam and aristolactam BⅡ) in Saururus chinensis by matrix solid phase dispersion (MSPD) and high-performance liquid chromatography-diode array detector (HPLC-DAD). In the optimized MSPD, 0.2 g S. chinensis powder was blended with 0.4 g silica gel, and 5 mL methanol was selected as elution solvent. The MSPD extraction achieved higher extraction recovery of four amides, and required less sample, solvent and preparation time, comparing with the conventional methods (Soxhlet and ultrasonic extraction). The assay was performed on a TSK gel ODS-100Z column (4.6 …


Composition Of Phenolic Compounds And Antioxidant Attributes Of Cyclea Gracillima Diels Extracts, J.-T. Lin, S.-C. Liu, L.-C. Kuo, D.-J. Yang 2020 Taiwan Food and Drug Administration

Composition Of Phenolic Compounds And Antioxidant Attributes Of Cyclea Gracillima Diels Extracts, J.-T. Lin, S.-C. Liu, L.-C. Kuo, D.-J. Yang

Journal of Food and Drug Analysis

Cyclea gracillima Diels is a Taiwanese native medicinal herb. However, there are currently few relevant reports on its biochemical activity. In this study, the antioxidant attributes of the ethanol and hot water extracts of this herb were assayed using in vitro models, including the following: 2,2-diphenyl-1-(2,4,6-trinitrophenyl)-hydrazyl radical scavenging, Trolox equivalent antioxidant capacity, reducing power, and chelating ferrous ions. The following biochemical models were also assayed: inhibition of human low density lipoprotein oxidation, inhibition of human erythrocyte hemolysis, and scavenging oxygen radicals in human blood. The composition and content of flavonoids and phenolic acids in these extracts were also analyzed. The …


Anti-Inflammatory Effect Of Cinnamaldehyde And Linalool From The Leaf Essential Oil Of Cinnamomum Osmophloeum Kanehira In Endotoxin-Induced Mice, S.-C. Lee, S.-Y. Wang, C.-C. Li, C.-T. Liu 2020 Taiwan Food and Drug Administration

Anti-Inflammatory Effect Of Cinnamaldehyde And Linalool From The Leaf Essential Oil Of Cinnamomum Osmophloeum Kanehira In Endotoxin-Induced Mice, S.-C. Lee, S.-Y. Wang, C.-C. Li, C.-T. Liu

Journal of Food and Drug Analysis

Cinnamomum osmophloeum Kanehira is a Taiwan native plant that belongs to genus Cinnamomum and is also known as pseudocinnamomum or indigenous cinnamon. Its leaf is traditionally used by local people in cooking and as folk therapy. We previously demonstrated the chemical composition and anti-inflammatory effect of leaf essential oil of Cinnamomum osmophloeum Kanehira of linalool chemotype in streptozotocin-induced diabetic rats and on endotoxin-injected mice. The aim of the present study is to evaluate whether cinnamaldehyde and linalool the active anti-inflammatory compounds in leaf essential oil of Cinnamomum osmophloeum Kanehira. Before the injection of endotoxin, C57BL/6 mice of the experimental groups …


Selected Essential Oils Inhibit Key Physiological Enzymes And Possess Intracellular And Extracellular Antimelanogenic Properties In Vitro, Z. Aumeeruddy-Elalfi, N. Lall, B. Fibrich, A. Blom van Staden, M. Hosenally, M.F. Mahomoodally 2020 Taiwan Food and Drug Administration

Selected Essential Oils Inhibit Key Physiological Enzymes And Possess Intracellular And Extracellular Antimelanogenic Properties In Vitro, Z. Aumeeruddy-Elalfi, N. Lall, B. Fibrich, A. Blom Van Staden, M. Hosenally, M.F. Mahomoodally

Journal of Food and Drug Analysis

Essential oils (EOs) extracted from six medicinal herbs and food plants [Cinnamomum zeylanicum (CZ), Psiadia arguta (PA), Psiadia terebinthina (PT), Citrus grandis (CGp), Citrus hystrix (CH), and Citrus reticulata (CR)] were studied for any inhibitory potential against key physiological enzymes involved in diabetes (α-glucosidase), skin aging (collagenase and elastase), and neurodegenerative disorders (acetylcholinesterase). Kinetic studies of the active EOs on the aforementioned enzymes were determined using Lineweaver–Burk plots. The intracellular and extracellular antimelanogenic potential of the EOs were evaluated on B16F10 mouse melanocytes. CH and CR were found to significantly inhibit (2.476 ± 0.13 μg/mL and 3.636 ± 0.10 μg/mL, …


Characterization Of An Extracellular Β-Glucosidase From Dekkera Bruxellensis For Resveratrol Production, H.-P. Kuo, R. Wang, C.-Y. Huang, J.-T. Lai, Y.-C. Lo, S.-T. Huang 2020 Taiwan Food and Drug Administration

Characterization Of An Extracellular Β-Glucosidase From Dekkera Bruxellensis For Resveratrol Production, H.-P. Kuo, R. Wang, C.-Y. Huang, J.-T. Lai, Y.-C. Lo, S.-T. Huang

Journal of Food and Drug Analysis

Polygonum cuspidatum is a widely grown crop with a rich source of polydatin (also called piceid) for resveratrol production. Resveratrol is produced from piceid via enzymatic cleavage of the sugar moiety of piceid. In this study, Dekkera bruxellensis mutants were selected based on their high p-nitrophenyl-β-D-glucopyranoside and piceid conversion activities. The enzyme responsible for piceid conversion was a heterodimeric protein complex that was predominantly secreted to the extracellular medium and consisted of two subunits at an equal ratio with molecular masses of 30.5 kDa and 48.3 kDa. The two subunits were identified as SCW4p and glucan-β-glucosidase precursor in D. bruxellensis. …


A Novel Poly (Glycine) Biosensor Towards The Detection Of Indigo Carmine: A Voltammetric Study, J.G.G. Manjunatha 2020 Taiwan Food and Drug Administration

A Novel Poly (Glycine) Biosensor Towards The Detection Of Indigo Carmine: A Voltammetric Study, J.G.G. Manjunatha

Journal of Food and Drug Analysis

The electrochemical behavior of indigo carmine (IC) at poly (glycine) modified carbon paste electrode (PGMCPE) was investigated by cyclic and differential pulse voltammetry. The oxidation peak of IC was observed in phosphate buffer of pH 6.5. The influence of different pH, scan rate, and concentration were analyzed. The probable reaction mechanism involved in the oxidation of IC was also proposed. Results showed that PGMCPE a remarkable electrocatalytic activity for the oxidation of IC under optimal conditions. The electrocatalytic response of the sensor was proportional to the IC concentration in the range of (2 × 10 −6 –1 × 10 −5 …


Codissolution Of Calcium Hydrogenphosphate And Sodium Hydrogencitrate In Water. Spontaneous Supersaturation Of Calcium Citrate Increasing Calcium Bioavailability, M. Vavrusova, B.P. Danielsen, A.C. Garcia, L.H. Skibsted 2020 Taiwan Food and Drug Administration

Codissolution Of Calcium Hydrogenphosphate And Sodium Hydrogencitrate In Water. Spontaneous Supersaturation Of Calcium Citrate Increasing Calcium Bioavailability, M. Vavrusova, B.P. Danielsen, A.C. Garcia, L.H. Skibsted

Journal of Food and Drug Analysis

The sparingly soluble calcium hydrogenphosphate dihydrate, co-dissolving in water during dissolution of freely soluble sodium hydrogencitrate sesquihydrate as caused by proton transfer from hydrogencitrate to hydrogenphosphate, was found to form homogenous solutions supersaturated by a factor up to 8 in calcium citrate tetrahydrate. A critical hydrogencitrate concentration for formation of homogeneous solutions was found to depend linearly on dissolved calcium hydrogenphosphate: [HCitr 2− ] = 14[CaHPO 4 ] - 0.05 at 25 °C. The lag phase for precipitation of calcium citrate tetrahydrate, as identified from FT-IR spectra, from these spontaneously formed supersaturated solutions was several hours, and the time to …


Hepatoprotective Effect Of The Ethanol Extract Of Polygonum Orientale On Carbon Tetrachloride-Induced Acute Liver Injury In Mice, Y.-J. Chiu, S.-C. Chou, C.-S. Chiu, C.-P. Kao, K.-C. Wu, C.-J. Chen, J.-C. Tsai, W.-H. Peng 2020 Taiwan Food and Drug Administration

Hepatoprotective Effect Of The Ethanol Extract Of Polygonum Orientale On Carbon Tetrachloride-Induced Acute Liver Injury In Mice, Y.-J. Chiu, S.-C. Chou, C.-S. Chiu, C.-P. Kao, K.-C. Wu, C.-J. Chen, J.-C. Tsai, W.-H. Peng

Journal of Food and Drug Analysis

Polygonum orientale L. (Polygonaceae) fruits have various medicinal uses, but their hepatoprotective effects have not yet been studied. This study investigated the hepatoprotective activity of the ethanolic extract of P. orientale (POE) fruits against carbon tetrachloride (CCl 4 )-induced acute liver injury (ALI). Mice were pretreated with POE (0.1, 0.5, and 1.0 g/kg) or silymarin (0.2 g/kg) for 5 consecutive days and administered a dose of 0.175% CCl 4 (ip) on the 5th day to induce ALI. Blood and liver samples were collected to measure antioxidative activity and cytokines. The bioactive components of POE were identified through high-performance liquid chromatography …


Non-Destructive Profiling Of Volatile Organic Compounds Using Hs-Spme/Gc–Ms And Its Application For The Geographical Discrimination Of White Rice, D.K. Lim, C. Mo, D.-K. Lee, N.P. Long, J. Lim, S.W. Kwon 2020 Taiwan Food and Drug Administration

Non-Destructive Profiling Of Volatile Organic Compounds Using Hs-Spme/Gc–Ms And Its Application For The Geographical Discrimination Of White Rice, D.K. Lim, C. Mo, D.-K. Lee, N.P. Long, J. Lim, S.W. Kwon

Journal of Food and Drug Analysis

The authenticity determination of white rice is crucial to prevent deceptive origin labeling and dishonest trading. However, a non-destructive and comprehensive method for rapidly discriminating the geographical origins of white rice between countries is still lacking. In the current study, we developed a volatile organic compound based geographical discrimination method using headspace solid-phase microextraction coupled to gas chromatography–mass spectrometry (HS-SPME/GC–MS) to discriminate rice samples from Korea and China. A partial least squares discriminant analysis (PLS-DA) model exhibited a good classification of white rice between Korea and China (accuracy = 0.958, goodness of fit = 0.937, goodness of prediction = 0.831, …


A Randomized, Double-Blind Clinical Study Of The Effects Of Ankascin 568 Plus On Blood Lipid Regulation, S.-F. Liu, Y.-R. Wang, Y.-C. Shen, C.-L. Chen, C.-N. Huang, T.-M. Pan, C.-K. Wang 2020 Taiwan Food and Drug Administration

A Randomized, Double-Blind Clinical Study Of The Effects Of Ankascin 568 Plus On Blood Lipid Regulation, S.-F. Liu, Y.-R. Wang, Y.-C. Shen, C.-L. Chen, C.-N. Huang, T.-M. Pan, C.-K. Wang

Journal of Food and Drug Analysis

Hyperlipidemia and inflammation play important roles in the development and progression of atherosclerosis. Atherosclerosis is regarded as an inflammatory response of blood vessels to injury at the start of atherosclerotic plaque formation, which then leads to cardiovascular events. Edible fungi of the Monascus species have been used as traditional Chinese medicines in East Asia for several centuries. The fermented products of Monascus purpureus NTU 568 possess a number of functional secondary metabolites including the anti-inflammatory pigments monascin and ankaflavin. Compounds derived from M. purpureus have been shown to have hypolipidemic effects. We aimed to evaluate the effects of M. purpureus …


Efficacy Of Protein Rich Pearl Powder On Antioxidant Status In A Randomized Placebo-Controlled Trial, H.-F. Chiu, S.-C. Hsiao, Y.-Y. Lu, Y.-C. Han, Y.-C. Shen, K. Venkatakrishnan, C.-K. Wang 2020 Taiwan Food and Drug Administration

Efficacy Of Protein Rich Pearl Powder On Antioxidant Status In A Randomized Placebo-Controlled Trial, H.-F. Chiu, S.-C. Hsiao, Y.-Y. Lu, Y.-C. Han, Y.-C. Shen, K. Venkatakrishnan, C.-K. Wang

Journal of Food and Drug Analysis

Pearl is one of the well-known traditional Chinese medicine (TCM) prescribed for treating various skin and bone related disorders due to its abundant proteins and mineral contents. The present investigation focused on antioxidation and life span prolonging effects from different extracts of pearl powder. During in vitro studies, various oxidative indices were evaluated, along with lifespan-prolonging effect were checked using wild-type Caenorhabditis elegans. For the clinical trial, 20 healthy middle-aged subjects were recruited and separated into 2 groups as experimental and placebo group, who received 3 g of pearl powder/d (n = 10) and 3 g of placebo/d (n = …


Rapid Characterization Of Metabolites In Soybean Using Ultra High Performance Liquid Chromatography Coupled With Electrospray Ionization Quadrupole Time-Of-Flight Mass Spectrometry (Uplc-Esi-Q-Tof-Ms/Ms) And Screening For Α-Glucosidase Inhibitory And Antioxidant Properties Through Different Solvent Systems, Y.H. Lee, B. Kim, S.-R. Hwang, K. Kim, J.H. Lee 2020 Taiwan Food and Drug Administration

Rapid Characterization Of Metabolites In Soybean Using Ultra High Performance Liquid Chromatography Coupled With Electrospray Ionization Quadrupole Time-Of-Flight Mass Spectrometry (Uplc-Esi-Q-Tof-Ms/Ms) And Screening For Α-Glucosidase Inhibitory And Antioxidant Properties Through Different Solvent Systems, Y.H. Lee, B. Kim, S.-R. Hwang, K. Kim, J.H. Lee

Journal of Food and Drug Analysis

This work was the first to investigate on the simultaneous characterization of metabolite profiles in soybean using UPLC-ESI-Q-TOF-MS/MS. Twenty two compositions were observed within 14 min from the methanol extract and confirmed as twelve isoflavones of three types and ten soyasaponins (Ab, Af, I–III, αg, βg, βa, γg, and γa). Moreover, the patterns of two chemicals showed considerable differences in seven solvent systems by HPLC analysis and their optimal extraction was achieved by 70% methanol (isoflavone: 4102.69 μg/g; soyasaponin: ten peaks). The second abundant isoflavones were detected in 50% methanol (4054.39 μg/g), followed by 30% methanol, 100% methanol, 10% methanol, …


Detection Of Lithospermate B In Rat Plasma At The Nanogram Level By Lc/Ms In Multi Reaction Monitoring Mode, T.-Y. Chung, N.-H. Lin, Y.-C. Li, T.-Y. Chen, P.-C. Kuo, W.-Y. Chen, J.T.C. Tzen 2020 Taiwan Food and Drug Administration

Detection Of Lithospermate B In Rat Plasma At The Nanogram Level By Lc/Ms In Multi Reaction Monitoring Mode, T.-Y. Chung, N.-H. Lin, Y.-C. Li, T.-Y. Chen, P.-C. Kuo, W.-Y. Chen, J.T.C. Tzen

Journal of Food and Drug Analysis

Low bioavailability and high binding affinity to plasma proteins led to the difficulty for the quantitative detection of lithospermate B (LSB) in plasma. This study aimed to develop a protocol for detecting LSB in plasma. A method was employed to quantitatively detect LSB of 5–500 ng/mL by LC/MS spectrometry in multi reaction monitoring mode via monitoring two major fragments with m/z values of 519 and 321 in the MS2 spectrum. To set up an adequate extraction solution to release LSB captured by plasma proteins, recovery yields of LSB extracted from rat plasma acidified by formic acid or HCl in the …


Study Of Forced Degradation Behavior Of Pramlintide Acetate By Hplc And Lc–Ms, Y. Yuan, Y.-B. Li, Z.-F. Tai, Y.-P. Xie, X.-F. Pu, J. Gao 2020 Taiwan Food and Drug Administration

Study Of Forced Degradation Behavior Of Pramlintide Acetate By Hplc And Lc–Ms, Y. Yuan, Y.-B. Li, Z.-F. Tai, Y.-P. Xie, X.-F. Pu, J. Gao

Journal of Food and Drug Analysis

Pramlintide acetate (Symlin ® ), a synthetic analogue of the human hormone amylin. It was approved in March 2005 as a subcutaneous injection for the adjunctive treatment of patients who have type 1 or 2 diabetes mellitus. The objective of current investigation was to study the degradation behavior of pramlintide acetate under different ICH recommended stress conditions by HPLC and LC–MS. Pramlintide acetate was subjected to stress conditions of hydrolysis (acidic or alkaline), oxidation, photolysis and thermal decomposition. Extensive degradation products were observed under the hydrolysis, oxidation or thermal stress conditions, while minimal degradation was found in the photolytic conditions. …


Methods For Efficient Analysis Of Tocopherols, Tocotrienols And Their Metabolites In Animal Samples With Hplc-Ec, M.-J. Lee, W. Feng, L. Yang, Y.-K. Chen, E. Chi, A. Liu, C.S. Yang 2020 Taiwan Food and Drug Administration

Methods For Efficient Analysis Of Tocopherols, Tocotrienols And Their Metabolites In Animal Samples With Hplc-Ec, M.-J. Lee, W. Feng, L. Yang, Y.-K. Chen, E. Chi, A. Liu, C.S. Yang

Journal of Food and Drug Analysis

Tocopherols and tocotrienols, collectively known as vitamin E, have received a great deal of attention because of their interesting biological activities. In the present study, we reexamined and improved previous methods of sample preparation and the conditions of high-performance liquid chromatography for more accurate quantification of tocopherols, tocotrienols and their major chain-degradation metabolites. For the analysis of serum tocopherols/tocotrienols, we reconfirmed our method of mixing serum with ethanol followed by hexane extraction. For the analysis of tissue samples, we improved our methods by extracting tocopherols/tocotrienols directly from tissue homogenate with hexane. For the analysis of total amounts (conjugated and unconjugated …


Use Of A Bayesian Approach In The Design And Evaluation Of Nce2s, C.-Y. Wang, L.-C. Chang, M.-S. Lin, C.-F. Hsiao, J.-D. Huang 2020 Taiwan Food and Drug Administration

Use Of A Bayesian Approach In The Design And Evaluation Of Nce2s, C.-Y. Wang, L.-C. Chang, M.-S. Lin, C.-F. Hsiao, J.-D. Huang

Journal of Food and Drug Analysis

Taiwan's regulatory agency defines New Chemical Entity 2 (NCE2) as a compound drug that has been approved and marketed for ten years in a top-ten pharmaceutically-advanced country but which is new in Taiwan. To apply for registration of NCE2 in Taiwan, a clinical trial may be conducted in Taiwan to evaluate the efficacy and safety. Since the NCE2 has been approved in at least one of the top-ten pharmaceutically-advanced countries, we can borrow the information from all of the observed data from other countries to synthesize the data from both Taiwan and other countries to assess the NCE2 efficacy. In …


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