Search Results - "Claycamp, Gregg"

Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets by Fahmy, Raafat, Kona, Ravikanth, Dandu, Ramesh, Xie, Walter, Claycamp, Gregg, Hoag, Stephen W.

“…As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; however, the number of…”
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Perspective on Quality Risk Management of Pharmaceutical Quality by Claycamp, H. Gregg

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Rapid Benefit-Risk Assessments: No Escape from Expert Judgments in Risk Management by Claycamp, H. Gregg

“…The “human health impacts assessment” described by Cox and Popken (this issue) is intended to be a benefit‐risk tool that avoids pitfalls of using expert…”
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Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets by Claycamp, H. Gregg, Kona, Ravikanth, Fahmy, Raafat, Hoag, Stephen W.

“…Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with…”
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Myeloperoxidase-catalyzed redox-cycling of phenol promotes lipid peroxidation and thiol oxidation in HL-60 cells by Goldman, Radoslav, Claycamp, Gregg H, Sweetland, Michael A, Sedlov, Andrew V, Tyurin, Vladimir A, Kisin, Elena R, Tyurina, Yulia Y, Ritov, Vladimir B, Wenger, Sharon L, Grant, Stephen G, Kagan, Valerian E

“…Various types of cancer occur in peroxidase-rich target tissues of animals exposed to aryl alcohols and amines. Unlike biotransformation by cytochrome P450…”
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A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process by Kothari, Bhaveshkumar H., Fahmy, Raafat, Claycamp, H. Gregg, Moore, Christine M. V., Chatterjee, Sharmista, Hoag, Stephen W.

“…ABSTRACT The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to…”
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Comparing a Statistical Model and Bayesian Approach to Establish the Design Space for the Coating of Ciprofloxacin HCl Beads at Different Scales of Production by Kothari, Bhaveshkumar H., Fahmy, Raafat, Claycamp, H. Gregg, Moore, Christine M. V., Chatterjee, Sharmista, Hoag, Stephen W.

“…The primary objective of this study was to compare two methods for establishing a design space for critical process parameters that affect ethylcellulose film…”
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Clinical Pharmacology of Topiramate versus Lamotrigine versus Phenobarbital: Comparison of Efficacy and Side Effects Using Odds Ratios by Lathers, Claire M., Schraeder, Paul L., Claycamp, H. Gregg

“…Clinical pharmacologists, neurologists, internists, and all health care givers must consider the efficacy, safety, and side effect profile of a given…”
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Probability concepts in quality risk management by Claycamp, H Gregg

“…Essentially any concept of risk is built on fundamental concepts of chance, likelihood, or probability. Although risk is generally a probability of loss of…”
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The reliability-quality relationship for quality systems and quality risk management by Claycamp, H Gregg, Rahaman, Faiad, Urban, Jason M

“…Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of…”
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Quality-by-Design III: Application of Near-Infrared Spectroscopy to Monitor Roller Compaction In-process and Product Quality Attributes of Immediate Release Tablets by Kona, Ravikanth, Fahmy, Raafat M., Claycamp, Gregg, Polli, James E., Martinez, Marilyn, Hoag, Stephen W.

“…The objective of this study is to use near-infrared spectroscopy (NIRS) coupled with multivariate chemometric models to monitor granule and tablet quality…”
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Antimicrobial resistance risk assessment in food safety by Claycamp, H Gregg, Hooberman, Barry H

“…Microbiological risk assessments generally focus on estimating adverse human health risks from exposures to human pathogenic microbes. The assessment of…”
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Phantom-derived estimation of effective dose equivalent from X rays with and without a lead apron by Mateya, C F, Claycamp, H G

“…Organ dose equivalents were measured in a humanoid phantom in order to estimate effective dose equivalent (H(E)) and effective dose (E) from low-energy x rays…”
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Dithiothreitol-induced oxidative damage to thymine and DNA in solution by Claycamp, H G

“…Studies on dithiothreitol-induced oxidative damage to thymine and DNA in solution are reported. The major thymine products, cis- and…”
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PDN-1: a spin-labeled analog of cis-diamminedichloroplatinum(II). Biophysical studies in aqueous, lipophilic, and biological media by Claycamp, H G, Zimbrick, J D

“…Biophysical and biochemical studies on a biradical-labeled analog of Cisplatin, PDN-1, in aqueous, biological, and lipophilic media are presented. The ESR…”
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Invited commentary: rapid benefit-risk assessments: no escape from expert judgments in risk management by Claycamp, H Gregg

“…The 'human health impacts assessment' described by Cox and Popken (this issue) is intended to be a benefit-risk tool that avoids pitfalls of using expert…”
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Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making by Claycamp, H Gregg

“…In this paper, the last two approaches are visited, while recognizing that this list is certainly not an exhaustive summary of the many decades of research and…”
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Phenol sensitization of DNA to subsequent oxidative damage in 8-hydroxyguanine assays by Claycamp, H G

“…The DNA base adduct, 8-hydroxyguanine (8-OHGua), has been reported to be a key biomarker relevant to carcinogenesis and cellular oxidative stress important in…”
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Non-random peroxidation of different classes of membrane phospholipids in live cells detected by metabolically integrated cis-parinaric acid by Ritov, Vladimir B., Banni, Sebastiano, Yalowich, Jack C., Day, Billy W., Claycamp, H. Gregg, Corongiu, Francesco P., Kagan, Valerian E.

“…Quantitative assays of lipid peroxidation in intact, living cells are essential for evaluating oxidative damage from various sources and for testing the…”
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Nitric oxide protects cardiomyocytes against tert-butyl hydroperoxide-induced formation of alkoxyl and peroxyl radicals and peroxidation of phosphatidylserine by Gorbunov, N V, Tyurina, Y Y, Salama, G, Day, B W, Claycamp, H G, Argyros, G, Elsayed, N M, Kagan, V E

“…We studied protective effects of nitric oxide against tert-butyl hydroperoxide-induced oxidative damage to cardiac myocytes. Two distinct free radicals…”
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