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29 results on '"Ripin, David H. Brown"'

1. Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial

Author

Venter, Willem Daniel Francois, Kambugu, Andrew, Chersich, Matthew F., Becker, Stephen, Hill, Andrew, Arulappan, Natasha, Moorhouse, Michelle, Majam, Mohammed, Akpomiemie, Godspower, Sokhela, Simiso, Poongulali, Selvamuthu, Feldman, Charles, Duncombe, Chris, Ripin, David H. Brown, Vos, Alinda, and Kumarasamy, Nagalingeswaran

Published
2019
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3. Transitioning Long-Acting Products to a Generic Marketplace: What's Missing?

Author

Ripin, David H Brown, Catlin, Kelly, Lewis, Linda, Resar, Danielle, Amole, Carolyn, Bollinger, Robert C, and Flexner, Charles

Subjects
*PREVENTIVE medicine, *DRUG therapy for malaria, *MORTALITY prevention, *HIV prevention, *DRUG therapy for tuberculosis, *INVESTMENTS, *DRUG approval, *HEALTH services accessibility, *MIDDLE-income countries, *VIRAL hepatitis, *SOCIAL stigma, *DRUG packaging, *ANTIRETROVIRAL agents, *MARKETING, *CONTRACEPTIVES, *GENERIC drugs, *DRUGS, *DECISION making, *LOW-income countries, *PHARMACEUTICAL chemistry, *DRUG development, *PATIENT compliance, *PHARMACEUTICAL industry
Abstract

Development of and increased access to generic oral medications to treat high-burden diseases including human immunodeficiency virus (HIV), tuberculosis, viral hepatitis, and malaria have had a major impact on reducing global morbidity and mortality. However, access and adherence to these life-saving treatments remains limited for some of the most vulnerable and underserved populations, for whom stigma, control, and discretion are critical to decisions around care. Current efforts to develop long-acting formulations to treat and prevent these conditions could overcome many of these barriers. However, generic manufacturing of these innovative products will be required to ensure affordable access to the communities and patients in greatest need. Strategic investments in new infrastructure will be required even before markets and manufacturing costs are clear, to ensure that access to these new products is not delayed, particularly for patients in low- and middle-income countries. Unlike conventional oral medications, long-acting products require greater investment for formulation, packaging, and delivery. The requirement for long-term bioequivalence studies will introduce additional delays in regulatory approval of generic long-acting products, and expedited approval pathways must be developed. Lessons learned from the development of long-acting hormonal contraceptives and long-acting antiretroviral products may provide a way forward. [ABSTRACT FROM AUTHOR]

Published
2022
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8. Oxidations

Author

Hansen, Eric C., primary, Perkins, Robert, additional, and Ripin, David H. Brown, additional

Published
2020
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9. Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial

Author

Global Health team 1, Unit Opleiding Aios, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Venter, Willem Daniel Francois, Kambugu, Andrew, Chersich, Matthew F, Becker, Stephen, Hill, Andrew, Arulappan, Natasha, Moorhouse, Michelle, Majam, Mohammed, Akpomiemie, Godspower, Sokhela, Simiso, Poongulali, Selvamuthu, Feldman, Charles, Duncombe, Chris, Ripin, David H Brown, Vos, Alinda, Kumarasamy, Nagalingeswaran, Global Health team 1, Unit Opleiding Aios, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Venter, Willem Daniel Francois, Kambugu, Andrew, Chersich, Matthew F, Becker, Stephen, Hill, Andrew, Arulappan, Natasha, Moorhouse, Michelle, Majam, Mohammed, Akpomiemie, Godspower, Sokhela, Simiso, Poongulali, Selvamuthu, Feldman, Charles, Duncombe, Chris, Ripin, David H Brown, Vos, Alinda, and Kumarasamy, Nagalingeswaran

Published
2019

10. Large-scale oxidations in the pharmaceutical industry

Author

Caron, Stephane, Dugger, Robert W., Ruggeri, Sally Gut, Ragan, John A., and Ripin, David H. Brown

Subjects
Oxidation-reduction reaction -- Research, Carbon compounds -- Chemical properties, Nitrogen compounds -- Chemical properties, Hydrogen -- Chemical properties, Chemistry
Abstract

Some oxidation reactions run in 1980 or later on a scale of 100g or larger or developed for to run on large scale are described. Oxidation reactions are powerful synthetic tools and many such reactions are described which include oxidation of carbon-carbon bonds, oxidation of carbon-hydrogen bonds, oxidation of carbon-nitrogen bonds, oxidation of carbon-oxygen bonds oxidation of alcohols, oxidation of sulfur and oxidation of carboxylic acids.

Published
2006

14. Route Development and Bulk Synthesis of CP-865,569

Author

Belecki, Katherine, primary, Berliner, Martin, additional, Bibart, Richard Todd, additional, Meltz, Cliff, additional, Ng, Karl, additional, Phillips, James, additional, Ripin, David H. Brown, additional, and Vetelino, Michael, additional

Published
2007
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16. Process Enabling and the Scale-Up of 6β-Hydroxymethylsulbactam and Its Esters

Author

Norris, Timothy, primary, Ripin, David H. Brown, additional, Ahlijanian, Paul, additional, Andresen, Brian M., additional, Barrila, Mark T., additional, Colon-Cruz, Roberto, additional, Couturier, Michel, additional, Hawkins, Joel M., additional, Loubkina, Ioulia V., additional, Rutherford, Jennifer, additional, Stickley, Kurt, additional, Wei, Lulin, additional, Vollinga, Roel, additional, de Pater, Robert, additional, Maas, Peter, additional, de Lange, Ben, additional, Callant, Dominique, additional, Konings, Jeroen, additional, Andrien, Jean, additional, Versleijen, Jos, additional, Hulshof, Jos, additional, Daia, Elena, additional, Johnson, Natalka, additional, and Sung, David W. L., additional

Published
2005
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17. Evaluation of Kilogram-Scale Sonagashira, Suzuki, and Heck Coupling Routes to Oncology Candidate CP-724,714

Author

Ripin, David H. Brown, primary, Bourassa, Dennis E., additional, Brandt, Thomas, additional, Castaldi, Michael J., additional, Frost, Heather N., additional, Hawkins, Joel, additional, Johnson, Phillip J., additional, Massett, Stephen S., additional, Neumann, Karin, additional, Phillips, James, additional, Raggon, Jeffery W., additional, Rose, Peter R., additional, Rutherford, Jennifer L., additional, Sitter, Barbara, additional, Stewart, A. Morgan, additional, Vetelino, Michael G., additional, and Wei, Lulin, additional

Published
2005
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19. Investigation of Practical Routes for the Kilogram-Scale Production of cis-3-Methylamino-4-methylpiperidines

Author

Cai, Weiling, primary, Colony, James L., additional, Frost, Heather, additional, Hudspeth, James P., additional, Kendall, Peter M., additional, Krishnan, Ashwin M., additional, Makowski, Teresa, additional, Mazur, Duane J., additional, Phillips, James, additional, Ripin, David H. Brown, additional, Ruggeri, Sally Gut, additional, Stearns, Jay F., additional, and White, Timothy D., additional

Published
2005
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22. Synthesis and Purification of 6-Ethoxy-4-oxo-1,4-dihydro-[1,5]naphthyridine-3-carboxylic Acid Benzylamide

Author

Beaudin, Justin, primary, Bourassa, Dennis E., additional, Bowles, Paul, additional, Castaldi, Michael J., additional, Clay, Ronald, additional, Couturier, Michel A., additional, Karrick, Gregory, additional, Makowski, Teresa W., additional, McDermott, Ruth E., additional, Meltz, Clifford N., additional, Meltz, Morgan, additional, Phillips, James E., additional, Ragan, John A., additional, Ripin, David H. Brown, additional, Singer, Robert A., additional, Tucker, John L., additional, and Wei, Lulin, additional

Published
2003
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23. Development of a Scaleable Route for the Production ofcis-N-Benzyl-3-methylamino-4-methylpiperidine

Author

Ripin, David H. Brown, primary, Abele, Stefan, additional, Cai, Weiling, additional, Blumenkopf, Todd, additional, Casavant, Jeffrey M., additional, Doty, Jonathan L., additional, Flanagan, Mark, additional, Koecher, Christian, additional, Laue, Klaus W., additional, McCarthy, Keith, additional, Meltz, Cliff, additional, Munchhoff, Mike, additional, Pouwer, Kees, additional, Shah, Bharat, additional, Sun, Jianmin, additional, Teixeira, John, additional, Vries, Ton, additional, Whipple, David A., additional, and Wilcox, Glenn, additional

Published
2002
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27. A New Strategy for Extending N-Acyl Imides as Chiral Auxiliaries for Aldol and Diels–Alder Reactions: Application to an Enantioselective Synthesis of a-Himachalene

Author

Evans, David A., Ripin, David H. Brown, Johnson, Jeffrey S., and Shaughnessy, Eileen A.

Abstract

New application for a chiral auxilary: N-acyl imides like 1, which is formed in an enantioselective aldol reaction, can be converted into thioesters and decarboxylated to give 2(TES = Et3Si). The oxazolidinone auxiliary is thus removed under mild conditions in a one-pot reaction, which is a key step in the elegant synthesis of the title compound.

Published
1997
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29. Efficacy and Safety of Tenofovir Disoproxil Fumarate Versus Low-Dose Stavudine Over 96 Weeks: A Multicountry Randomized, Noninferiority Trial.

Author

Venter WDF, Kambugu A, Chersich MF, Becker S, Hill A, Arulappan N, Moorhouse M, Majam M, Akpomiemie G, Sokhela S, Poongulali S, Feldman C, Duncombe C, Ripin DHB, Vos A, and Kumarasamy N

Subjects
Adult, Double-Blind Method, Equivalence Trials as Topic, Female, HIV Infections epidemiology, Humans, Male, South Africa epidemiology, Uganda epidemiology, Young Adult, Anti-HIV Agents therapeutic use, Bone and Bones drug effects, HIV Infections drug therapy, Kidney drug effects, Stavudine therapeutic use, Tenofovir therapeutic use
Abstract

Background: Reducing doses of antiretroviral drugs, including stavudine (d4T), may lower toxicity, while preserving efficacy. There are substantial concerns about renal and bone toxicities of tenofovir disoproxil fumarate (TDF)., Setting: HIV-1-infected treatment-naive adults in India, South Africa, and Uganda., Methods: A phase-4, 96-week, randomized, double-blind, noninferiority trial compared d4T 20 mg twice daily and TDF, taken in combination with lamivudine (3TC) and efavirenz (EFV). The primary endpoint was the proportion of participants with HIV-1 RNA <50 copies per milliliter at 48 weeks. Adverse events assessments included measures of bone density and body fat. The trial is registered on Clinicaltrials.gov (NCT02670772)., Results: Between 2012 and 2014, 536 participants were recruited per arm. At week 96, trial completion rates were 75.7% with d4T/3TC/EFV (n = 406) and 82.1% with TDF/3TC/EFV (n = 440, P = 0.011). Noncompletion was largely due to virological failure [6.2% (33) with d4T/3TC/EFV versus 5.4% (29) with TDF/3TC/EFV; P = 0.60]. For the primary endpoint, d4T/3TC/EFV was noninferior to TDF/3TC/EFV (79.3%, 425/536 versus 80.8% 433/536; difference = -1.49%, 95% CI: -6.3 to 3.3; P < 0.001). Drug-related adverse event discontinuations were higher with d4T (6.7%, 36), than TDF (1.1%, 6; P < 0.001). Lipodystrophy was more common with d4T (5.6%, 30) than TDF (0.2%, 1; P < 0.001). Creatinine clearance increased in both arms, by 18.1 mL/min in the d4T arm and 14.2 mL/min with TDF (P = 0.03). Hip bone density measures, however, showed greater loss with TDF., Conclusions: Low-dose d4T combined with 3TC/EFV demonstrated noninferior virological efficacy compared with TDF/3TC/EFV, but mitochondrial toxicity remained high. Little renal toxicity occurred in either arm. Implications of bone mineral density changes with TDF warrant investigation.

Published
2019
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