Search Results - "Colgan, Stephen T"

Aqueous Phosphoric Acid as a Mild Reagent for Deprotection of tert-Butyl Carbamates, Esters, and Ethers by Li, Bryan, Berliner, Martin, Buzon, Richard, Chiu, Charles K.-F, Colgan, Stephen T, Kaneko, Takushi, Keene, Nandell, Kissel, William, Le, Tung, Leeman, Kyle R, Marquez, Brian, Morris, Ronald, Newell, Lisa, Wunderwald, Silke, Witt, Michael, Weaver, John, Zhang, Zhijun, Zhang, Zhongli

“…Aqueous phosphoric acid (85 wt %) is an effective, environmentally benign reagent for the deprotection of tert-butyl carbamates, tert-butyl esters, and…”
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Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations? by Diaz, Dorys Argelia, Colgan, Stephen T., Langer, Connie S., Bandi, Nagesh T., Likar, Michael D., Van Alstine, Leslie

“…The objective of this article is to compare and contrast the international expectations associated with the model-independent similarity factor approach to…”
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Science and Risked-Based Stability Testing Strategies—a Test Case on the Global Implementation and Regulatory Reception by Diaz, Dorys Argelia, Lynch, Michael, McMahon, Megan, Oblessuc, Raquel, Colgan, Stephen T.

“…The global regulatory implementation and acceptance of a science and risk-based stability (SRB) strategies for a stable drug product is reviewed. This…”
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Enhancing the Dissolution Stability of Hard Gelatin Capsules Using Activated Carbon as a Packaging Component by Likar, Michael D, Carroll, Sophia C, Colgan, Stephen T, Yeoh, Thean, MacDonald, Bruce C, Johnson, Gail M, Space, J Sean

“…Hard gelatin capsule (HGC) shells are widely used to encapsulate drugs for oral delivery but are vulnerable to gelatin cross-linking, which can lead to slower…”
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Use of Activated Carbon in Packaging to Attenuate Formaldehyde-Induced and Formic Acid-Induced Degradation and Reduce Gelatin Cross-Linking in Solid Dosage Forms by Colgan, Stephen T, Zelesky, Todd C, Chen, Raymond, Likar, Michael D, MacDonald, Bruce C, Hawkins, Joel M, Carroll, Sophia C, Johnson, Gail M, Space, J Sean, Jensen, James F, DeMatteo, Vincent A

“…Formaldehyde and formic acid are reactive impurities found in commonly used excipients and can be responsible for limiting drug product shelf-life. Described…”
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Erratum to: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations? by Diaz, Dorys Argelia, Colgan, Stephen T., Langer, Connie S., Bandi, Nagesh, Likar, Michael D., Van Alstine, Leslie

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Assay and purity evaluation of sunepitron hydrochloride by reversed-phase liquid chromatography using a reference standard composite by Colgan, Stephen T, Dumont, Monica L, Ruggeri, Sally G

“…A reference standard composite was prepared that contained the active pharmaceutical ingredient sunepitron and three potential impurities. This standard was…”
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Assay and purity evaluation of CP-93,393-1 by reversed-phase liquid chromatography: A snapshot of current practices for liquid chromatography methods development and validation by Colgan, Stephen T, Reed, Robert H, Dumont, Monica L, Haggan, Gary R

“…CP-93,393-1 is a new chemical entity under development for the treatment of anxiety and depression. This paper describes the selection and validation of a…”
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Opportunities for Lean Stability Strategies by Colgan, Stephen T., Timpano, Robert J., Roberts, Matthew, Weaver, Roger, Ryan, Kevin, Fields, Kevin W., Scrivens, Garry

“…The International Conference on Harmonization (ICH) has provided practical guidance on the amount and type of stability data needed to support marketing…”
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The Application of Science- and Risk-Based Concepts to Drug Substance Stability Strategies by Colgan, Stephen T., Watson, Timothy J., Whipple, Robert D., Nosal, Roger, Beaman, Jon V., De Antonis, David M.

“…The International Conference on Harmonization (ICH) has provided practical guidance on the amount and type of drug substance stability data needed to support…”
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Derivatization of ethylene dibromide with silica-supported silver picrate for improved high-performance liquid chromatographic detection by Colgan, Stephen T, Krull, Ira S, Dorschel, Craig, Bidlingmeyer, Brian

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A Design Space Verification Protocol for a Small Molecule Drug Substance by Watson, Timothy J. N., Bonsignore, Holly, Callaghan-Manning, Eileen A., Colgan, Stephen T., Fitzsimons, Paul, Garcia, Thomas P., Groskoph, John G., Lynch, Michael P., Nosal, Roger, McMahon, Megan E., Singer, Robert A., Thomson, Nicholas M., Sluggett, Gregory W., Schulz, Darren J., Twohig, Shirley

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Aqueous phosphoric acid as a mild reagent for deprotection of the t-butoxycarbonyl group by Li, Bryan, Bemish, Raymond, Buzon, Richard A., Chiu, Charles K.-F., Colgan, Stephen T., Kissel, William, Le, Tung, Leeman, Kyle R., Newell, Lisa, Roth, Joshua

“…Aqueous phosphoric acid (85 wt%) is an efficient and mild reagent for the deprotection of N-BOC groups. Acid sensitive functionalities including benzyl and…”
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Stereoselective synthesis of 5-[(1 S)- N-Boc-amino-(2 S)-(3-fluorophenyl)ethyl]-dihydrofuran-2-one by Li, Bryan, Buzon, Richard A., Chiu, Charles K.-F., Colgan, Stephen T., Jorgensen, Matthew L., Kasthurikrishnan, Narasim

“…Phthalic anhydride as thiolate scavenger effectively preserved the enantiopurity of α-aminoketone, thus affording the convenient synthesis of the titled…”
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Assay and purity evaluation of CP-93,393-1 by reversed-phase liquid chromatography by Colgan, Stephen T, Reed, Robert H, Dumont, Monica L, Haggan, Gary R

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Assay and purity evaluation of 5-chlorooxindole by liquid chromatography by Colgan, Stephen T., Haggan, Gary R., Reed, Robert H.

“…5-Chlorooxindole (5-CO) is a starting material for tenidap sodium, a pharmaceutical drug candidate produced by Pfizer. To insure potency and purity of the drug…”
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Investigation of Cyclam-Containing Mobile Phases for the Liquid Chromatographic Analysis of Tenidap by Colgan, Stephen T., Hammen, Philip D., Knutson, Kimberlee L., Bordner, Jon

“…Tenidap is a new oxindole-based cytokine-modulating agent used for the treatment of arthritis. Initial analyses of tenidap for tenidap content and…”
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