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1. Guía internacional para una dosificación más segura de la clozapina en adultos mediante el uso de 6 titulaciones personalizadas de dosis basados en la etnicidad, la proteína C reactiva y los niveles de clozapina

Author

de Leon, Jose, Schoretsanitis, Georgios, Smith, Robert L., Molden, Espen, Solismaa, Anssi, Seppälä, Niko, Kopeček, Miloslav, Švancer, Patrik, Olmos, Ismael, Ricciardi, Carina, Iglesias-Garcia, Celso, Iglesias-Alonso, Ana, Spina, Edoardo, Ruan, Can-Jun, Wang, Chuan-Yue, Wang, Gang, Tang, Yi-Lang, Lin, Shih-Ku, Lane, Hsien-Yuan, Kim, Yong Sik, Kim, Se Hyun, Rajkumar, Anto P., González-Esquivel, Dinora F., Jung-Cook, Helgi, Baptista, Trino, Rohde, Christopher, Nielsen, Jimmi, Verdoux, Hélène, Quiles, Clelia, Sanz, Emilio J., De las Cuevas, Carlos, Cohen, Dan, Schulte, Peter F.J., Ertuğrul, Aygün, Anıl Yağcıoğlu, A. Elif, Chopra, Nitin, McCollum, Betsy, Shelton, Charles, Cotes, Robert O., Kaithi, Arun R., Kane, John M., Farooq, Saeed, Ng, Chee H., Bilbily, John, Hiemke, Christoph, López-Jaramillo, Carlos, McGrane, Ian, Lana, Fernando, Eap, Chin B., Arrojo-Romero, Manuel, Rădulescu, Flavian Ştefan, Seifritz, Erich, Every-Palmer, Susanna, Bousman, Chad A., Bebawi, Emmanuel, Bhattacharya, Rahul, Kelly, Deanna L., Otsuka, Yuji, Lazary, Judit, Torres, Rafael, Yecora, Agustin, Motuca, Mariano, Chan, Sherry Kit Wa, Zolezzi, Monica, Ouanes, Sami, De Berardis, Domenico, Grover, Sandeep, Procyshyn, Ric M., Adebayo, Richard A., Kirilochev, Oleg O., Soloviev, Andrey, Fountoulakis, Konstantinos N., Wilkowska, Alina, Cubała, Wiesław Jerzy, Ayub, Muhammad, Silva, Alzira, Bonelli, Raphael M., Villagrán-Moreno, José María, Crespo-Facorro, Benedicto, Temmingh, Henk, Decloedt, Eric, Pedro, Maria Rosel, Takeuchi, Hiroyoshi, Tsukahara, Masaru, Gründer, Gerhard, Sagud, Marina, Celofiga, Andreja, Ignjatovic Ristic, Dragana, Ortiz, Bruno Bertolucci, Elkis, Helio, Pacheco Palha, António José, Llerena, Adrián, Fernandez-Egea, Emilio, Siskind, Dan, Weizman, Abraham, Masmoudi, Rim, Mohd Saffian, Shamin, Leung, Jonathan G., Buckley, Peter F., Marder, Stephen R., Citrome, Leslie, Freudenreich, Oliver, Correll, Christoph U., and Müller, Daniel J.

Published
2023
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11. In vitro and in vivo cysticidal activity of extracts and isolated flavanone from the bark of Prunus serotina: A bio-guided study

Author

Palomares-Alonso, Francisca, Rojas-Tomé, Irma Susana, Palencia Hernández, Guadalupe, Jiménez-Arellanes, María Adelina, Macías-Rubalcava, Martha Lydia, González-Maciel, Angélica, Ramos-Morales, Andrea, Santiago-Reyes, Rosalba, Castro, Nelly, González-Hernández, Iliana, Rufino-González, Yadira, and Jung-Cook, Helgi

Published
2017
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20. Pharmacokinetic Study of Intranasal Dexamethasone and Methylprednisolone Compared with Intravenous Administration: Two Open-Label, Single-Dose, Two-Period, Two-Sequence, Cross-Over Study in Healthy Volunteers

Author

Cárdenas, Graciela, Bobes, Raúl J., Fragoso, Gladis, Pérez-Osorio, Nicolas I., Hernández, Marisela, Espinosa, Alejandro, Fleury, Agnes, Flores, José, Consortium, The Revival Project Consortium The Revival Project, Laclette, Juan Pedro, Sciutto, Edda, and Jung-Cook, Helgi

Subjects
intranasal, Pharmaceutical Science, dexamethasone, pharmacokinetics, methylprednisolone, neuroinflammation
Abstract

Dexamethasone (DXM) and methylprednisolone (MEP) are potent glucocorticoids used to control several inflammatory conditions. Evidence of delayed DXM reaching the central nervous system (CNS) as well as tachyphylaxis and systemic, undesirable side effects are the main limitations of peripheral delivery. Intranasal administration offers direct access to the brain as it bypasses the blood–brain barrier. The Mucosal Atomization Device is an optimal tool that can achieve rapid absorption into the CNS and the bloodstream across mucosal membranes. This study was designed to evaluate and compare the bioavailability of DXM and MEP after intranasal versus intravenous administration. Two open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover studies were conducted, which involved healthy male and female adult volunteers. After intranasal administration, DXM and MEP were detected in plasma after the first sampling time. Mean peak concentrations of DXM and MEP were 86.61 ng/mL at 60 min and 843.2 ng/mL at 1.5 h post-administration, respectively. DXM and MEP showed high absolute bioavailability, with values of 80% and 95%, respectively. No adverse effects were observed. DXM and MEP systemic bioavailability by intranasal administration was comparable with the intravenous one, suggesting that the intranasal route can be used as a non-invasive and appropriate alternative for systemic drug delivery.

Published
2022
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24. An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

Author

de Leon, Jose, Schoretsanitis, Georgios, Smith, Robert L., Molden, Espen, Solismaa, Anssi, Seppala, Niko, Kopecek, Miloslav, Svancer, Patrik, Olmos, Ismael, Ricciardi, Carina, Iglesias-Garcia, Celso, Iglesias-Alonso, Ana, Spina, Edoardo, Ruan, Can-Jun, Wang, Chuan-Yue, Wang, Gang, Tang, Yi-Lang, Lin, Shih-Ku, Lane, Hsien-Yuan, Kim, Yong Sik, Kim, Se Hyun, Rajkumar, Anto P., Gonzalez-Esquivel, Dinora F., Jung-Cook, Helgi, Baptista, Trino, Rohde, Christopher, Nielsen, Jimmi, Verdoux, Helene, Quiles, Clelia, Sanz, Emilio J., De las Cuevas, Carlos, Cohen, Dan, Schulte, Peter F. J., Ertugrul, Aygun, Chopra, Nitin, McCollum, Betsy, Shelton, Charles, Cotes, Robert O., Kaithi, Arun R., Kane, John M., Farooq, Saeed, Ng, Chee H., Bilbily, John, Hiemke, Christoph, Lopez-Jaramillo, Carlos, McGrane, Ian, Lana, Fernando, Eap, Chin B., Arrojo-Romero, Manuel, Seifritz, Erich, Every-Palmer, Susanna, Bousman, Chad A., Bebawi, Emmanuel, Bhattacharya, Rahul, Kelly, Deanna L., Otsuka, Yuji, Lazary, Judit, Torres, Rafael, Yecora, Agustin, Motuca, Mariano, Chan, Sherry K. W., Zolezzi, Monica, Ouanes, Sami, De Berardis, Domenico, Grover, Sandeep, Procyshyn, Ric M., Adebayo, Richard A., Kirilochev, Oleg O., Soloviev, Andrey, Fountoulakis, Konstantinos N., Wilkowska, Alina, Ayub, Muhammad, Silva, Alzira, Bonelli, Raphael M., Villagran-Moreno, Jose M., Crespo-Facorro, Benedicto, Temmingh, Henk, Decloedt, Eric, Pedro, Maria R., Takeuchi, Hiroyoshi, Tsukahara, Masaru, Gruender, Gerhard, Sagud, Marina, Celofiga, Andreja, Ristic, Dragana Ignjatovic, Ortiz, Bruno B., Elkis, Helio, Palha, Antonio J. Pacheco, LLerena, Adrian, Fernandez-Egea, Emilio, Siskind, Dan, Weizman, Abraham, Masmoudi, Rim, Saffian, Shamin Mohd, Leung, Jonathan G., Buckley, Peter F., Marder, Stephen R., Citrome, Leslie, Freudenreich, Oliver, Correll, Christoph U., Muller, Daniel J., Anil Yagcioglu, A. Elif, Radulescu, Flavian S., Cubala, Wieslaw J., de Leon, Jose, Schoretsanitis, Georgios, Smith, Robert L., Molden, Espen, Solismaa, Anssi, Seppala, Niko, Kopecek, Miloslav, Svancer, Patrik, Olmos, Ismael, Ricciardi, Carina, Iglesias-Garcia, Celso, Iglesias-Alonso, Ana, Spina, Edoardo, Ruan, Can-Jun, Wang, Chuan-Yue, Wang, Gang, Tang, Yi-Lang, Lin, Shih-Ku, Lane, Hsien-Yuan, Kim, Yong Sik, Kim, Se Hyun, Rajkumar, Anto P., Gonzalez-Esquivel, Dinora F., Jung-Cook, Helgi, Baptista, Trino, Rohde, Christopher, Nielsen, Jimmi, Verdoux, Helene, Quiles, Clelia, Sanz, Emilio J., De las Cuevas, Carlos, Cohen, Dan, Schulte, Peter F. J., Ertugrul, Aygun, Chopra, Nitin, McCollum, Betsy, Shelton, Charles, Cotes, Robert O., Kaithi, Arun R., Kane, John M., Farooq, Saeed, Ng, Chee H., Bilbily, John, Hiemke, Christoph, Lopez-Jaramillo, Carlos, McGrane, Ian, Lana, Fernando, Eap, Chin B., Arrojo-Romero, Manuel, Seifritz, Erich, Every-Palmer, Susanna, Bousman, Chad A., Bebawi, Emmanuel, Bhattacharya, Rahul, Kelly, Deanna L., Otsuka, Yuji, Lazary, Judit, Torres, Rafael, Yecora, Agustin, Motuca, Mariano, Chan, Sherry K. W., Zolezzi, Monica, Ouanes, Sami, De Berardis, Domenico, Grover, Sandeep, Procyshyn, Ric M., Adebayo, Richard A., Kirilochev, Oleg O., Soloviev, Andrey, Fountoulakis, Konstantinos N., Wilkowska, Alina, Ayub, Muhammad, Silva, Alzira, Bonelli, Raphael M., Villagran-Moreno, Jose M., Crespo-Facorro, Benedicto, Temmingh, Henk, Decloedt, Eric, Pedro, Maria R., Takeuchi, Hiroyoshi, Tsukahara, Masaru, Gruender, Gerhard, Sagud, Marina, Celofiga, Andreja, Ristic, Dragana Ignjatovic, Ortiz, Bruno B., Elkis, Helio, Palha, Antonio J. Pacheco, LLerena, Adrian, Fernandez-Egea, Emilio, Siskind, Dan, Weizman, Abraham, Masmoudi, Rim, Saffian, Shamin Mohd, Leung, Jonathan G., Buckley, Peter F., Marder, Stephen R., Citrome, Leslie, Freudenreich, Oliver, Correll, Christoph U., Muller, Daniel J., Anil Yagcioglu, A. Elif, Radulescu, Flavian S., and Cubala, Wieslaw J.

Abstract

This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas' original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300-600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75-150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175-300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100-200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250-400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150-300 mg/day, and 6) in the US with ancestries other than from Asia or the original people fr

Published
2022

26. Correction: An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

Author

de Leon, Jose, additional, Schoretsanitis, Georgios, additional, Smith, Robert L., additional, Molden, Espen, additional, Solismaa, Anssi, additional, Seppälä, Niko, additional, Kopeček, Miloslav, additional, Švancer, Patrik, additional, Olmos, Ismael, additional, Ricciardi, Carina, additional, Iglesias-Garcia, Celso, additional, Iglesias-Alonso, Ana, additional, Spina, Edoardo, additional, Ruan, Can-Jun, additional, Wang, Chuan-Yue, additional, Wang, Gang, additional, Tang, Yi-Lang, additional, Lin, Shih-Ku, additional, Lane, Hsien-Yuan, additional, Kim, Yong Sik, additional, Kim, Se Hyun, additional, Rajkumar, Anto P., additional, González-Esquivel, Dinora F., additional, Jung-Cook, Helgi, additional, Baptista, Trino, additional, Rohde, Christopher, additional, Nielsen, Jimmi, additional, Verdoux, Hélène, additional, Quiles, Clelia, additional, Sanz, Emilio J., additional, De Las Cuevas, Carlos, additional, Cohen, Dan, additional, Schulte, Peter F.J., additional, Ertuğrul, Aygün, additional, Anıl Yağcıoğlu, A. Elif, additional, Chopra, Nitin, additional, McCollum, Betsy, additional, Shelton, Charles, additional, Cotes, Robert O., additional, Kaithi, Arun R., additional, Kane, John M., additional, Farooq, Saeed, additional, Ng, Chee H., additional, Bilbily, John, additional, Hiemke, Christoph, additional, López-Jaramillo, Carlos, additional, McGrane, Ian, additional, Lana, Fernando, additional, Eap, Chin B., additional, Arrojo-Romero, Manuel, additional, Rădulescu, Flavian Ş., additional, Seifritz, Erich, additional, Every-Palmer, Susanna, additional, Bousman, Chad A., additional, Bebawi, Emmanuel, additional, Bhattacharya, Rahul, additional, Kelly, Deanna L., additional, Otsuka, Yuji, additional, Lazary, Judit, additional, Torres, Rafael, additional, Yecora, Agustin, additional, Motuca, Mariano, additional, Chan, Sherry K.W., additional, Zolezzi, Monica, additional, Ouanes, Sami, additional, De Berardis, Domenico, additional, Grover, Sandeep, additional, Procyshyn, Ric M., additional, Adebayo, Richard A., additional, Kirilochev, Oleg O., additional, Soloviev, Andrey, additional, Fountoulakis, Konstantinos N., additional, Wilkowska, Alina, additional, Cubała, Wiesław J., additional, Ayub, Muhammad, additional, Silva, Alzira, additional, Bonelli, Raphael M., additional, Villagrán-Moreno, José M., additional, Crespo-Facorro, Benedicto, additional, Temmingh, Henk, additional, Decloedt, Eric, additional, Pedro, Maria R., additional, Takeuchi, Hiroyoshi, additional, Tsukahara, Masaru, additional, Gründer, Gerhard, additional, Sagud, Marina, additional, Celofiga, Andreja, additional, Ignjatovic Ristic, Dragana, additional, Ortiz, Bruno B., additional, Elkis, Helio, additional, Pacheco Palha, António J., additional, LLerena, Adrián, additional, Fernandez-Egea, Emilio, additional, Siskind, Dan, additional, Weizman, Abraham, additional, Masmoudi, Rim, additional, Mohd Saffian, Shamin, additional, Leung, Jonathan G., additional, Buckley, Peter F., additional, Marder, Stephen R., additional, Citrome, Leslie, additional, Freudenreich, Oliver, additional, Correll, Christoph U., additional, and Müller, Daniel J., additional

Published
2022
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28. Pharmacokinetic Study of Intranasal Dexamethasone and Methylprednisolone Compared with Intravenous Administration: Two Open-Label, Single-Dose, Two-Period, Two-Sequence, Cross-Over Study in Healthy Volunteers.

Author

Cárdenas, Graciela, Bobes, Raúl J., Fragoso, Gladis, Pérez-Osorio, Nicolas I., Hernández, Marisela, Espinosa, Alejandro, Fleury, Agnes, Flores, José, Laclette, Juan Pedro, Sciutto, Edda, and Jung-Cook, Helgi

Subjects
DEXAMETHASONE, INTRAVENOUS therapy, BIOAVAILABILITY, INTRANASAL administration, METHYLPREDNISOLONE, PHARMACOKINETICS, CENTRAL nervous system
Abstract

Dexamethasone (DXM) and methylprednisolone (MEP) are potent glucocorticoids used to control several inflammatory conditions. Evidence of delayed DXM reaching the central nervous system (CNS) as well as tachyphylaxis and systemic, undesirable side effects are the main limitations of peripheral delivery. Intranasal administration offers direct access to the brain as it bypasses the blood–brain barrier. The Mucosal Atomization Device is an optimal tool that can achieve rapid absorption into the CNS and the bloodstream across mucosal membranes. This study was designed to evaluate and compare the bioavailability of DXM and MEP after intranasal versus intravenous administration. Two open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover studies were conducted, which involved healthy male and female adult volunteers. After intranasal administration, DXM and MEP were detected in plasma after the first sampling time. Mean peak concentrations of DXM and MEP were 86.61 ng/mL at 60 min and 843.2 ng/mL at 1.5 h post-administration, respectively. DXM and MEP showed high absolute bioavailability, with values of 80% and 95%, respectively. No adverse effects were observed. DXM and MEP systemic bioavailability by intranasal administration was comparable with the intravenous one, suggesting that the intranasal route can be used as a non-invasive and appropriate alternative for systemic drug delivery. [ABSTRACT FROM AUTHOR]

Published
2023
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29. An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

Author

de Leon, Jose, additional, Schoretsanitis, Georgios, additional, Smith, Robert L., additional, Molden, Espen, additional, Solismaa, Anssi, additional, Seppälä, Niko, additional, Kopeček, Miloslav, additional, Švancer, Patrik, additional, Olmos, Ismael, additional, Ricciardi, Carina, additional, Iglesias-Garcia, Celso, additional, Iglesias-Alonso, Ana, additional, Spina, Edoardo, additional, Ruan, Can-Jun, additional, Wang, Chuan-Yue, additional, Wang, Gang, additional, Tang, Yi-Lang, additional, Lin, Shih-Ku, additional, Lane, Hsien-Yuan, additional, Kim, Yong Sik, additional, Kim, Se Hyun, additional, Rajkumar, Anto P., additional, González-Esquivel, Dinora F., additional, Jung-Cook, Helgi, additional, Baptista, Trino, additional, Rohde, Christopher, additional, Nielsen, Jimmi, additional, Verdoux, Hélène, additional, Quiles, Clelia, additional, Sanz, Emilio J., additional, De Las Cuevas, Carlos, additional, Cohen, Dan, additional, Schulte, Peter F.J., additional, Ertuğrul, Aygün, additional, Anıl Yağcıoğlu, A. Elif, additional, Chopra, Nitin, additional, McCollum, Betsy, additional, Shelton, Charles, additional, Cotes, Robert O., additional, Kaithi, Arun R., additional, Kane, John M., additional, Farooq, Saeed, additional, Ng, Chee H., additional, Bilbily, John, additional, Hiemke, Christoph, additional, López-Jaramillo, Carlos, additional, McGrane, Ian, additional, Lana, Fernando, additional, Eap, Chin B., additional, Arrojo-Romero, Manuel, additional, Rădulescu, Flavian Ş., additional, Seifritz, Erich, additional, Every-Palmer, Susanna, additional, Bousman, Chad A., additional, Bebawi, Emmanuel, additional, Bhattacharya, Rahul, additional, Kelly, Deanna L., additional, Otsuka, Yuji, additional, Lazary, Judit, additional, Torres, Rafael, additional, Yecora, Agustin, additional, Motuca, Mariano, additional, Chan, Sherry K.W., additional, Zolezzi, Monica, additional, Ouanes, Sami, additional, De Berardis, Domenico, additional, Grover, Sandeep, additional, Procyshyn, Ric M., additional, Adebayo, Richard A., additional, Kirilochev, Oleg O., additional, Soloviev, Andrey, additional, Fountoulakis, Konstantinos N., additional, Wilkowska, Alina, additional, Cubała, Wiesław J., additional, Ayub, Muhammad, additional, Silva, Alzira, additional, Bonelli, Raphael M., additional, Villagrán-Moreno, José M., additional, Crespo-Facorro, Benedicto, additional, Temmingh, Henk, additional, Decloedt, Eric, additional, Pedro, Maria R., additional, Takeuchi, Hiroyoshi, additional, Tsukahara, Masaru, additional, Gründer, Gerhard, additional, Sagud, Marina, additional, Celofiga, Andreja, additional, Ignjatovic Ristic, Dragana, additional, Ortiz, Bruno B., additional, Elkis, Helio, additional, Pacheco Palha, António J., additional, LLerena, Adrián, additional, Fernandez-Egea, Emilio, additional, Siskind, Dan, additional, Weizman, Abraham, additional, Masmoudi, Rim, additional, Mohd Saffian, Shamin, additional, Leung, Jonathan G., additional, Buckley, Peter F., additional, Marder, Stephen R., additional, Citrome, Leslie, additional, Freudenreich, Oliver, additional, Correll, Christoph U., additional, and Müller, Daniel J., additional

Published
2021
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30. Relevance of NR1I2 variants on carbamazepine therapy in Mexican Mestizos with epilepsy at a tertiary-care hospital

Author

Fricke-Galindo, Ingrid, primary, Jung-Cook, Helgi, additional, Martínez-Juárez, Iris E, additional, Monroy-Jaramillo, Nancy, additional, Ortega-Vázquez, Alberto, additional, Rojas-Tomé, Irma S, additional, Dorado, Pedro, additional, Peñas-Lledó, Eva, additional, Llerena, Adrián, additional, and López-López, Marisol, additional

Published
2021
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37. Population Pharmacokinetics Of Levetiracetam In Mexican Adult Patients With Epilepsy (4643)

Author

Hernandez-Mitre, Maria Patricia, primary, Medellin-Garibay, Susanna Edith, additional, Rodriguez-Leyva, Ildefonso, additional, Castillo-Ibarra, Herlinda, additional, Rodríguez-Pinal, Cristian Jasmin, additional, Zarazua-Guzman, Sergio, additional, Jung-Cook, Helgi Helene, additional, Romano-Moreno, Silvia, additional, and del Carlmen Milan-Segovia, Rosa, additional

Published
2020
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43. Genomic Ancestry, CYP2D6, CYP2C9, and CYP2C19 Among Latin Americans

Author

Rodrigues-Soares, Fernanda, Peñas-Lledó, Eva, Tarazona, Eduardo, Sosa-Macías, Martha, Terán, Enrique, López-López, Marisol, Rodeiro Guerra, Idania, Moya, Graciela, Calzadilla, Luis R., Ramírez-Roa, Ronald, Grazina, Manuela, Estévez-Carrizo, Francisco E., Barrantes-Reynolds, Ramiro, Llerena, A., Altamirano-Tinoco, Catalina, Alvárez, Mayra, Borbón Orjuela, Angélica Rocío, Céspedes-Garro, Carolina, Cobaleda, Jesús, Andrés, F. de, Delgado, René, Dorado, Pedro, Fariñas, Humberto, Ferreiro, Verónica, Fricke-Galindo, Ingrid, Galaviz-Hernández, Carlos, Garza Ocañas, Lourdes, Gilman, Robert H., Hernández, Francisco, Jíménez-Arce, Gerardo, Jung-Cook, Helgi, Lares-Aseff, Ismael, Lazalde-Ramos, Blanca Patricia, Michelin, Lucas, Monroy-Jaramillo, Nancy, Gómez Naranjo, María Eugenia, Ortega-Vázquez, Alberto, Ortiz-López, Rocío, Pérez, Bárbaro, Pérez-Páramo, Yadira Xitlalli, Remirez, Diadelis, Rojas-Martínez, Augusto, Sarmiento, Alba Piedad, Scliar, Marilia, Terán, Santiago, and Zamudio Zea, Roxana

Subjects
CYP2C9, Latin Americans, Genetic genealogy, Black People, Genomics, Context (language use), CYP2C19, Biology, digestive system, 030226 pharmacology & pharmacy, White People, 03 medical and health sciences, 0302 clinical medicine, CYP, Genetic variation, Humans, purl.org/pe-repo/ocde/ford#3.01.05 [https], Pharmacology (medical), Allele, skin and connective tissue diseases, Alleles, Cytochrome P-450 CYP2C9, Ancestry, Pharmacology, Genetics, CYP2D6, Racial Groups, Native American, Genetic Variation, Cytochrome P-450 CYP2C19, Latin America, Phenotype, Cytochrome P-450 CYP2D6, Pharmacogenetics, Genomic Ancestry, 030220 oncology & carcinogenesis, Indians, North American, Latin American
Abstract

We present the distribution of CYP2D6, CYP2C9, and CYP2C19 variants and predicted phenotypes in 33 native and admixed populations from Ibero-America (n > 6,000) in the context of genetic ancestry (n = 3,387). Continental ancestries are the major determinants of frequencies of the increased-activity allele CYP2C19*17 and CYP2C19 gUMs (negatively associated with Native American ancestry), decreased-activity alleles CYP2D6*41 and CYP2C9*2 (positively associated with European ancestry), and decreased-activity alleles CYP2D6*17 and CYP2D6*29 (positively associated with African ancestry). For the rare alleles, CYP2C9*2 and CYPC19*17, European admixture accounts for their presence in Native American populations, but rare alleles CYP2D6*5 (null-activity), CYP2D6-multiplication alleles (increased activity), and CYP2C9*3 (decreased-activity) were present in the pre-Columbian Americas. The study of a broad spectrum of Native American populations from different ethno-linguistic groups show how autochthonous diversity shaped the distribution of pharmaco-alleles and give insights on the prevalence of clinically relevant phenotypes associated with drugs, such as paroxetine, tamoxifen, warfarin, and clopidogrel.

Published
2019

44. Comparative in vitro dissolution and in vivo bioavailability of commercial amlodipine tablets

Author

Jung-Cook, Helgi, Mayet-Cruz, Lourdes, and Girard-Cuesy, María Elena

Subjects
Biopharmaceutics Classification System (BCS), Dissolution, Bioequivalence, Solubility, Permeability
Abstract

Purpose: To evaluate the in vivo and in vitro behavior of amlodipine immediate release products.Methods: Three Mexican amlodipine products and the innovator (Norvasc®) were evaluated. Three bioequivalence studies were performed in 24 healthy male and female volunteers each. Plasma concentrations were determined using a liquid chromatographic method coupled with tandem mass spectrometry (LC/MS/MS). Dissolution profiles were evaluated using USP type apparatus 2 at 75 rpm and 500 mL of HCl 0.1N, pH 4.5 and pH 6.8. Also, the dissolution behavior of different lots of the innovator product was evaluated using apparatus 1 or 2 and 900 mL of buffer pH 6.8.Results: All the generic products under study were bioequivalent to the innovator. In vitro data showed that although at pH 1.2 and 4.5, the products met the specifications for very rapidly dissolving products but at pH 6.8, neither the innovator nor the test products complied with the criteria for rapidly dissolving products. When the study was performed at pH 6.8 in 900 mL of medium, the innovator showed a rapid dissolution behavior.Conclusion: The results show that the use of WHO conditions (900 mL of media, apparatus 2 at 75 rpm) are more adequate to predict the in vivo behavior of the amlodipine products.Keywords: Biopharmaceutics Classification System (BCS), Dissolution, Bioequivalence, Solubility, Permeability

Published
2018

45. Evaluation of New Benzimidazole Derivatives as Cysticidal Agents: In Vitro, in Vivo and Docking Studies

Author

González-Hernández, Iliana, primary, Palomares-Alonso, Francisca, additional, Becerril-Vega, José, additional, Melchor-Doncel de la Torre, Silvia, additional, Hernández-Luis, Francisco, additional, Rodriguez-Morales, Sergio, additional, Aguayo-Ortiz, Rodrigo, additional, Dominguez, Laura, additional, Rodríguez-Balderas, César A., additional, González-Maciel, Angélica, additional, Rojas-Tomé, Irma Susana, additional, Castro, Nelly, additional, and Jung-Cook, Helgi, additional

Published
2019
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48. DEVELOPMENT OF A DISSOLUTION TEST FOR MELATONIN SUBLINGUAL TABLETS USING A FACTORIAL EXPERIMENTAL DESIGN.

Author

MAYET-CRUZ, LOURDES, RODRÍGUEZ, JUAN MANUEL, and JUNG-COOK, HELGI

Subjects
FACTORIAL experiment designs, EXPERIMENTAL design, MELATONIN, GENERIC products, EVALUATION methodology
Abstract

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Published
2021
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49. Interethnic Variability in CYP2D6, CYP2C9, and CYP2C19 Genes and Predicted Drug Metabolism Phenotypes Among 6060 Ibero- and Native Americans: RIBEF-CEIBA Consortium Report on Population Pharmacogenomics

Author

Naranjo, María-Eugenia G., primary, Rodrigues-Soares, Fernanda, additional, Peñas-Lledó, Eva M., additional, Tarazona-Santos, Eduardo, additional, Fariñas, Humberto, additional, Rodeiro, Idania, additional, Terán, Enrique, additional, Grazina, Manuela, additional, Moya, Graciela E., additional, López-López, Marisol, additional, Sarmiento, Alba P., additional, Calzadilla, Luis R., additional, Ramírez-Roa, Ronald, additional, Ortiz-López, Rocío, additional, Estévez-Carrizo, Francisco E., additional, Sosa-Macías, Martha, additional, Barrantes, Ramiro, additional, LLerena, Adrián, additional, Fcrreiro, Verónica, additional, Scliar, Marilia O., additional, Gouveia, Mateus H, additional, Borbón, Angélica, additional, Jiménez-Arce, Gerardo, additional, Céspedes-Garro, Carolina, additional, Álvárez, Mayra, additional, Delgado, René, additional, Remirez, Diadelis, additional, Pérez, Bárbaro, additional, Hernández, Francisco, additional, Terán, Santiago, additional, Rojas-Martinez, Augusto, additional, Garza-Ocañas, Lourdes, additional, Pérez-Páramo, Yadira X., additional, Ortega-Vázquez, Alberto, additional, Monroy-Jaramillo, Nancy, additional, Jung-Cook, Helgi, additional, Fricke-Galindo, Ingrid, additional, Galaviz-Hernández, Carlos, additional, Lares-Aseff, Ismael, additional, Lazalde-Ramos, Blanca P., additional, Altamirano Tinoco, Catalina, additional, Zamudio, Roxana, additional, Gilman, Robert H., additional, Cobaleda, Jesús, additional, de Andrés, Fernando, additional, Dorado, Pedro, additional, Naranjo, Eugenia G., additional, and E. Estévez-Carrizo, Francisco, additional

Published
2018
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