Search Results - "Ide, Nathan"

Nitrosamine Reactivity: A Survey of Reactions and Purge Processes by Borths, Christopher J, Burns, Michael, Curran, Timothy, Ide, Nathan D

“…Drug recalls have led to increased regulatory scrutiny into the formation and presence of nitrosamine (N-nitrosoamine) impurities in medicines. This review…”
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Synthesis of ABBV-168, a 2′-Bromouridine for the Treatment of Hepatitis C by Voight, Eric A, Brown, Brian S, Greszler, Stephen N, Halvorsen, Geoff T, Zhao, Gang, Kruger, Albert W, Hartung, John, Lukin, Kirill A, Martinez, Steven R, Moschetta, Eric G, Tudesco, Michael T, Ide, Nathan D

“…ABBV-168 is a dihalogenated nucleotide under investigation for the treatment of hepatitis C virus. Three synthetic routes aimed at achieving the…”
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Palbociclib Commercial Manufacturing Process Development. Part I: Control of Regioselectivity in a Grignard-Mediated SNAr Coupling by Duan, Shengquan, Place, David, Perfect, Hahdi H, Ide, Nathan D, Maloney, Mark, Sutherland, Karen, Price Wiglesworth, Kristin E, Wang, Ke, Olivier, Mark, Kong, Fangming, Leeman, Kyle, Blunt, Jon, Draper, John, McAuliffe, Marie, O’Sullivan, Maria, Lynch, Denis

“…This is the first in a series of three papers describing commercial manufacturing process development for palbociclib (1). This manuscript focuses on the SNAr…”
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Risk Assessment of the Leachables’ Profile for Small-Molecule Pharmaceutical Drug Substances by Reddy, Rajarathnam E, Hu, Wenbin, Lowry, Brian R, Fogle, Jace L, Malick, Robert E, Erexson, Greg, Westerberg, John M, Carragher, Adelia L, Robinson, Emily E, Orihuela, Carlos A, Hillier, Michael C, Davis, Steven R, Kruk, Paul E, Ide, Nathan D, Mlinar, Laurie, Mulhern, Mathew M, Engstrom, Kenneth M, Chaaya, Elie, McKee, Laura A, Manning, Patrick E, Tirino, Pasquale, Joudioux, Roberta, Cornelio, Lisa

“…Appropriate control of impurities from all sources is critically important during the development of a pharmaceutical product. One class of impurity that has…”
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New Semi-Automated Computer-Based System for Assessing the Purge of Mutagenic Impurities by Burns, Michael J, Ott, Martin A, Teasdale, Andrew, Stalford, Susanne A, Antonucci, Vincent, Baumann, Jens-Christoph, Brown, Roland, Covey-Crump, Elizabeth M, Elder, David, Elliott, Eric, Fennell, Jared W, Gallou, Fabrice, Ide, Nathan D, Itoh, Tetsuji, Jordine, Guido, Kallemeyn, Jeffrey M, Lauwers, Dirk, Looker, Adam R, Lovelle, Lucie E, Molzahn, Robert, Schils, Didier, Schulte Oestrich, Rolf, Sluggett, Gregory W, Stevenson, Neil, Talavera, Pere, Urquhart, Michael W, Varie, David L, Welch, Dennie S

“…The ICH M7 guidance provides a series of flexible control options for the control of (potentially) mutagenic impurities (PMIs) that fully align with key…”
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A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies by Barber, Chris, Antonucci, Vincent, Baumann, Jens-Christoph, Brown, Roland, Covey-Crump, Elizabeth, Elder, David, Elliott, Eric, Fennell, Jared W., Gallou, Fabrice, Ide, Nathan D., Jordine, Guido, Kallemeyn, Jeffrey M., Lauwers, Dirk, Looker, Adam R., Lovelle, Lucie E., McLaughlin, Mark, Molzahn, Robert, Ott, Martin, Schils, Didier, Oestrich, Rolf Schulte, Stevenson, Neil, Talavera, Pere, Teasdale, Andrew, Urquhart, Michael W., Varie, David L., Welch, Dennie

“…The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This…”
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Annulation of Thioimidates and Vinyl Carbodiimides to Prepare 2-Aminopyrimidines, Competent Nucleophiles for Intramolecular Alkyne Hydroamination. Synthesis of (−)-Crambidine by Perl, Nicholas R, Ide, Nathan D, Prajapati, Sudeep, Perfect, Hahdi H, Durón, Sergio G, Gin, David Y

“…A convergent synthesis of (−)-crambidine is reported. The sequence capitalizes on two novel key transformations, including a [4+2] annulation of thioimidates…”
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Palbociclib Commercial Manufacturing Process Development. Part II: Regioselective Heck Coupling with Polymorph Control for Processability by Maloney, Mark T, Jones, Brian P, Olivier, Mark A, Magano, Javier, Wang, Ke, Ide, Nathan D, Palm, Andrew S, Bill, David R, Leeman, Kyle R, Sutherland, Karen, Draper, John, Daly, Adrian M, Keane, Joseph, Lynch, Denis, O’Brien, Marie, Tuohy, Joanne

“…A three-step commercial manufacturing route has been developed for palbociclib, a highly selective, reversible inhibitor of CDK 4/6. The second step, which…”
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Palbociclib Commercial Manufacturing Process Development. Part III. Deprotection Followed by Crystallization for API Particle Property Control by Chekal, Brian P, Ewers, Jason, Guinness, Steven M, Ide, Nathan D, Leeman, Kyle R, Post, Ronald J, Rane, Anil M, Sutherland, Karen, Wang, Ke, Webster, Mark, Withbroe, Gregory J, Draper, John, Lynch, Denis, McAuliffe, Marie, Keane, Joseph

“…A three-step commercial manufacturing route has been developed for palbociclib, a highly selective, reversible inhibitor of CDK 4/6. The third step of the…”
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Aziridine-2-carboxylic Acid-Containing Peptides:  Application to Solution- and Solid-Phase Convergent Site-Selective Peptide Modification by Galonić, Danica P, Ide, Nathan D, van der Donk, Wilfred A, Gin, David Y

“…The development of a method for site- and stereoselective peptide modification using aziridine-2-carboxylic acid-containing peptides is described. A…”
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Development of a Practical and Convergent Process for the Preparation of Sulopenem by Brenek, Steven J, Caron, Stéphane, Chisowa, Esmort, Delude, Mark P, Drexler, Michele T, Ewing, Marcus D, Handfield, Robert E, Ide, Nathan D, Nadkarni, Durgesh V, Nelson, Jade D, Olivier, Mark, Perfect, Hahdi H, Phillips, James E, Teixeira, John J, Weekly, R. Matt, Zelina, John P

“…Previous synthetic processes for the preparation of sulopenem involved multistep linear sequences in which the chiral sulfoxide side chain was introduced early…”
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Synthesis of Filibuvir. Part III. Development of a Process for the Reductive Coupling of an Aldehyde and a β‑Keto-lactone by Ide, Nathan D, Ragan, John. A, Bellavance, Gabriel, Brenek, Steve J, Cordi, Eric M, Jensen, Grace O, Jones, Kris N, LaFrance, Danny, Leeman, Kyle R, Letendre, Leo J, Place, David, Stanchina, Corey L, Sluggett, Gregory W, Strohmeyer, Holly, Blunt, Jon, Meldrum, Kevin, Taylor, Stuart, Byrne, Ciaran, Lynch, Denis, Mullane, Sandra, O’Sullivan, Maria M, Whelan, Marcella

“…Development of a reductive coupling of a β-keto-lactone and an aldehyde is described, in which the Hantzsch ester serves as an inexpensive and convenient…”
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Development of a Practical and Efficient Synthesis of Chloromethyl 2-Ethoxy-2-methylpropanoate by Ragan, John A, Ide, Nathan D, Cai, Weiling, Cawley, James J, Colon-Cruz, Roberto, Kumar, Rajesh, Peng, Zhihui, Vanderplas, Brian C

“…An efficient synthesis of chloromethyl 2-ethoxy-2-methylpropanoate from 2-bromoisobutyric acid is reported. Four developments were key to this route: (i) a…”
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Palbociclib Commercial Manufacturing Process Development. Part I: Control of Regioselectivity in a Grignard-Mediated S N Ar Coupling by Duan, Shengquan, Place, David, Perfect, Hahdi H., Ide, Nathan D., Maloney, Mark, Sutherland, Karen, Price Wiglesworth, Kristin E., Wang, Ke, Olivier, Mark, Kong, Fangming, Leeman, Kyle, Blunt, Jon, Draper, John, McAuliffe, Marie, O’Sullivan, Maria, Lynch, Denis

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The Delivery of Flexibility from the Application of QbD to API Development by Popkin, Matt E., Borman, Phil J., Omer, Batool Ahmed, Seibert, Kevin D., Srivastava, Sushil, Lepore, John V., Hobson, Lindsay, Donaubauer, John, Curran, Timothy, Ide, Nathan, Tymonko, Steven, Looker, Adam, Kallemeyn, Jeffrey M.

“…This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility…”
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I. Efforts toward the total synthesis of (-)-crambidine. II. Reactions of Azy(3-Me)-containing peptides with thiols and selenols by Ide, Nathan D

“…An approach to (-)-crambidine, utilizing a key [4+2] annulation reaction between a thioimidate and an electron deficient vinyl carbodiimide, has been…”
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Lactone synthesis via biotransformations of γ-hydroxyamides by Taylor, Stephen K., Arnold, Carrie R., Gerds, Aaron T., Ide, Nathan D., Law, Keri M., Kling, Dale L., Pridgeon, Matthew G., Simons, Lloyd J., Vyvyan, James R., Yamaoka, Jennifer S., Liao, Min-Ken, Goyne, Thomas E.

“…An enzyme was expressed in E. coli from a cloned amidase gene. When characterized, it was more enantioselective than commercial amidases. Three pheromones were…”
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I. Efforts toward the total synthesis of (-)-crambidine. II. Reactions of Azy(3-Me)-containing peptides with thiols and selenols by Ide, Nathan D

“…An approach to (-)-crambidine, utilizing a key [4+2] annulation reaction between a thioimidate and an electron deficient vinyl carbodiimide, has been…”
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A FACILE, HIGH YIELD SYNTHESIS OF γ- AND δ-HYDROXYAMIDES by Taylor, Stephen K., Ide, Nathan D., Silver, Michael E., Stephan, Mari L.

“…γ- and δ-Hydroxyamides can be prepared in high yields by heating a lactone with ammonia in a pressure tube. The ammonia can be removed by controlled…”
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Statistical tools to aid in the assessment of critical process parameters by Wang, Ke, Ide, Nathan D, Dirat, Olivier, Subashi, Ann K, Thomson, Nicholas M, Vukovinsky, Kim E, Watson, Timothy J

“…Assessing impact based solely on statistical significance (p-value) is not appropriate, because statistical significance does not take into account the…”
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