Search Results - "Yu, Lawrence X"

Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control by Yu, Lawrence X.

“…Purpose The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality…”
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Dissolution Testing for Generic Drugs: An FDA Perspective by Anand, Om, Yu, Lawrence X., Conner, Dale P., Davit, Barbara M.

“…In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how…”
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A Provisional Biopharmaceutical Classification of the Top 200 Oral Drug Products in the United States, Great Britain, Spain, and Japan by Takagi, Toshihide, Ramachandran, Chandrasekharan, Bermejo, Marival, Yamashita, Shinji, Yu, Lawrence X, Amidon, Gordon L

“…Orally administered, immediate-release (IR) drug products in the top 200 drug product lists from the United States (US), Great Britain (GB), Spain (ES), and…”
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Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration by Davit, Barbara M, Nwakama, Patrick E, Buehler, Gary J, Conner, Dale P, Haidar, Sam H, Patel, Devvrat T, Yang, Yongsheng, Yu, Lawrence X, Woodcock, Janet

“…Background: In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the…”
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International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences by Davit, Barbara, Braddy, April C., Conner, Dale P., Yu, Lawrence X.

“…The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when…”
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Understanding Pharmaceutical Quality by Design by Yu, Lawrence X., Amidon, Gregory, Khan, Mansoor A., Hoag, Stephen W., Polli, James, Raju, G. K., Woodcock, Janet

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Applications of Human Pharmacokinetic Prediction in First-in-Human Dose Estimation by Zou, Peng, Yu, Yanke, Zheng, Nan, Yang, Yongsheng, Paholak, Hayley J., Yu, Lawrence X., Sun, Duxin

“…Quantitative estimations of first-in-human (FIH) doses are critical for phase I clinical trials in drug development. Human pharmacokinetic (PK) prediction…”
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FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications by Yu, Lawrence X., Raw, Andre, Wu, Larisa, Capacci-Daniel, Christina, Zhang, Ying, Rosencrance, Susan

“…[Display omitted] This paper describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The…”
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The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation by Jiang, Wenlei, Kim, Stephanie, Zhang, Xinyuan, Lionberger, Robert A., Davit, Barbara M., Conner, Dale P., Yu, Lawrence X.

“…Advances in predicting in vivo performance of drug products has the potential to change how drug products are developed and reviewed. Modeling and simulation…”
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The future of pharmaceutical quality and the path to get there by Yu, Lawrence X., Kopcha, Michael

“…While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector. However, consumers and patients deserve six…”
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High-Permeability Criterion for BCS Classification: Segmental/pH Dependent Permeability Considerations by Dahan, Arik, Miller, Jonathan M, Hilfinger, John M, Yamashita, Shinji, Yu, Lawrence X, Lennernäs, Hans, Amidon, Gordon L

“…The FDA classifies a drug substance as high-permeability when the fraction of dose absorbed (F abs) in humans is 90% or higher. This direct correlation between…”
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Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters by Kulkarni, Chetan P, Yang, Jia, Koleske, Megan L, Lara, Giovanni, Alam, Khondoker, Raw, Andre, Rege, Bhagwant, Zhao, Liang, Lu, Dongmei, Zhang, Lei, Yu, Lawrence X, Lionberger, Robert A, Giacomini, Kathleen M, Kroetz, Deanna L, Yee, Sook Wah

“…The presence of mutagenic and carcinogenic N-nitrosamine impurities in medicinal products poses a safety risk. While incorporating antioxidants in formulations…”
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A network of regulatory innovations to improve FDA quality assessments of human drug applications by Tran, Russie, Fraser, Grace, Fisher, Adam C., Lee, Sau L., Boam, Ashley, Tsinontides, Stelios, Maguire, Jennifer, Yu, Lawrence X., Rosencrance, Susan, Kozlowski, Steven, Henry, Don

“…A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality…”
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Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future by Arden, N. Sarah, Fisher, Adam C., Tyner, Katherine, Yu, Lawrence X., Lee, Sau L., Kopcha, Michael

“…[Display omitted] Over the last two centuries, medicines have evolved from crude herbal and botanical preparations into more complex manufacturing of…”
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Using Partial Area for Evaluation of Bioavailability and Bioequivalence by Chen, Mei-Ling, Davit, Barbara, Lionberger, Robert, Wahba, Zakaria, Ahn, Hae-Young, Yu, Lawrence X.

“…ABSTRACT Assessment of bioavailability/bioequivalence generally relies on the comparison of rate and extent of drug absorption between products. Rate of…”
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Prediction of volume of distribution at steady state in humans: comparison of different approaches by Zou, Peng, Zheng, Nan, Yang, Yongsheng, Yu, Lawrence X, Sun, Duxin

“…Reasonable prediction of volume of distribution at steady state (Vd(ss)) in humans is required for screening drug candidates, evaluating drug safety, and…”
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Feasibility studies of utilizing disk intrinsic dissolution rate to classify drugs by Yu, Lawrence X, Carlin, Alan S, Amidon, Gordon L, Hussain, Ajaz S

“…The purpose of this report was to investigate the feasibility of using disk intrinsic dissolution rate (DIDR) to determine solubility class membership. We…”
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Pharmaceutical characterization and thermodynamic stability assessment of a colloidal iron drug product: Iron sucrose by Shah, Rakhi B., Yang, Yongsheng, Khan, Mansoor A., Raw, Andre, Yu, Lawrence X., Faustino, Patrick J.

“…Molecular weight stability of iron sucrose under accelerated (40°C) and extreme (90°C) stress conditions monitored by gel permeation chromatogram (GPC): 0 day…”
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Understanding Pharmaceutical Quality by Design by Yu, Lawrence X., Amidon, Gregory, Khan, Mansoor A., Hoag, Stephen W., Polli, James, Raju, G. K., Woodcock, Janet

“…This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a…”
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Comparative evaluation of the in vitro efficacy of lanthanum carbonate chewable tablets by Yang, Yongsheng, Bykadi, Srikant, Carlin, Alan S, Shah, Rakhi B, Yu, Lawrence X, Khan, Mansoor A

“…The aims of this study were to systematically evaluate the effects of pH levels, phosphate concentrations, and tablet integrity on the phosphate binding…”
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