Search Results - "Chow, Shein‐Chung"

Sample size re‐estimation in clinical trials by Wang, Peijin, Chow, Shein‐Chung

“…In clinical trials, sample size re‐estimation is often conducted at interim. The purpose is to determine whether the study will achieve study objectives if the…”
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Adaptive Clinical Trial Design by Chow, Shein-Chung

“…In recent years, the use of adaptive design methods in clinical trials based on accumulated data at interim has received much attention because of its…”
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Bioavailability and bioequivalence in drug development by Chow, Shein-Chung

“…Bioavailability is referred to as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes…”
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Adaptive design methods in clinical trials - a review by Chow, Shein-Chung, Chang, Mark

“…In recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility…”
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Innovative thinking of clinical investigation for rare disease drug development by Wang, Peijin, Chow, Shein-Chung

“…Abstract For the development of a test treatment or drug product, it is necessary to conduct composite hypothesis testing to test for effectiveness and safety…”
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Innovative design and analysis for rare disease drug development by Chow, Shein-Chung, Huang, Zhipeng

“…One of the most challenges for rare diseases drug development is probably the availability of subjects with the diseases under a small patient population. It…”
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Helicobacter pylori‐associated peptic ulcer disease: A retrospective analysis of post‐treatment testing practices by Feder, Rachel, Posner, Shai, Qin, Yi, Zheng, Jiayin, Chow, Shein‐Chung, Garman, Katherine S.

“…Background & Aims Guidelines recommend that patients with Helicobacter pylori (H. pylori)‐associated peptic ulcer disease (PUD) receive H. pylori eradication…”
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On Bayesian Analysis and Hypothesis Testing in the Determination of Bioequivalence by Schuirmann, Donald J., Grosser, Stella, Chattopadhyay, Somesh, Chow, Shein‐Chung

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A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission by Liu, Jiajun, Chow, Shein-Chung

“…In clinical trials, it is not uncommon that the primary analysis fails to achieve the study objective for demonstrating the safety and efficacy of a test…”
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Statistical Methods for Conditional Survival Analysis by Jung, Sin-Ho, Lee, Ho Yun, Chow, Shein-Chung

“…We investigate the survival distribution of the patients who have survived over a certain time period. This is called a conditional survival distribution. In…”
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On assessing bioequivalence and interchangeability between generics based on indirect comparisons by Zheng, Jiayin, Chow, Shein‐Chung, Yuan, Mengdie

“…As more and more generics become available in the market place, the safety/efficacy concerns may arise as the result of interchangeably use of approved…”
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Demonstrating effectiveness or demonstrating not ineffectiveness - A potential solution for rare disease drug product development? by Chow, Shein-Chung, Huang, Zhipeng

“…For review and approval of new drug products, substantial evidence regarding safety and effectiveness of the drug products under investigation are necessarily…”
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Tenofovir versus entecavir in lowering the risk of hepatocellular carcinoma development in patients with chronic hepatitis B: a critical systematic review and meta-analysis by Li, Min, Lv, Tingting, Wu, Shanshan, Wei, Wei, Wu, Xiaohai, Ou, Xiaojuan, Ma, Hong, Chow, Shein-Chung, Kong, Yuanyuan, You, Hong, Jia, Jidong

“…Background Controversy exists on whether tenofovir disoproxil fumarate (TDF) is superior to entecavir (ETV) in lowering the risk of hepatocellular carcinoma…”
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On the regulatory approval pathway of biosimilar products by Wang, Jun, Chow, Shein-Chung

“…Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated…”
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Assessing biosimilarity and interchangeability of biosimilar products by Chow, Shein-Chung

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Outcomes of liver retransplantation in patients with primary sclerosing cholangitis by Henson, Jacqueline B., Patel, Yuval A., King, Lindsay Y., Zheng, Jiayin, Chow, Shein‐Chung, Muir, Andrew J.

“…Liver retransplantation in patients with primary sclerosing cholangitis (PSC) has not been well studied. The aims of this study were to characterize patients…”
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Simultaneous confidence interval methods for analytical similarity assessment by Zheng, Jiayin, Yin, Donglei, Yuan, Mengdie, Chow, Shein-Chung

“…In analytical similarity assessment of a biosimilar product, key quality attributes of the test and reference products need to be shown statistically similar…”
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The use of 95% CI or 90% CI for drug product development - a controversial issue? by Chow, Shein-Chung, Zheng, Jiayin

“…For review and approval of drug products, a 95% confidence interval approach for evaluation of new drugs is commonly used, while a 90% confidence interval…”
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Criteria for dose-finding in two-stage seamless adaptive design by Zheng, Jiayin, Chow, Shein-Chung

“…In pharmaceutical/clinical development, two-stage seamless adaptive designs are commonly considered. Such designs include a two-stage phase I/II or phase…”
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Unified approaches to assessing treatment effect of traditional Chinese medicine based on health profiles by Cheng, Bin, Zhang, Bingzhi, Chow, Shein-Chung

“…Two dissimilarity indices are introduced to measure the disharmony of a human body system by mimicking the population bioequivalence and the individual…”
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