{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,17]],"date-time":"2023-09-17T15:50:42Z","timestamp":1694965842737},"reference-count":33,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2015,9,1]],"date-time":"2015-09-01T00:00:00Z","timestamp":1441065600000},"content-version":"tdm","delay-in-days":691,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharmacology"],"published-print":{"date-parts":[[2013,12]]},"DOI":"10.1002\/jcph.184","type":"journal-article","created":{"date-parts":[[2013,10,12]],"date-time":"2013-10-12T01:30:21Z","timestamp":1381541421000},"page":"1268-1276","source":"Crossref","is-referenced-by-count":3,"title":["Sex differences in the pharmacokinetics and bioequivalence of the delayed-release combination of doxylamine succinate-pyridoxine hydrochloride; implications for pharmacotherapy in pregnancy"],"prefix":"10.1002","volume":"53","author":[{"given":"Gideon","family":"Koren","sequence":"first","affiliation":[{"name":"Department of Pediatrics; Division of Clinical Pharmacology\/Toxicology; The Motherisk Program; The Hospital for Sick Children and University of Toronto; Toronto Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manon","family":"Vranderick","sequence":"additional","affiliation":[{"name":"Duchesnay; Inc.; Blainville Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simerpal K.","family":"Gill","sequence":"additional","affiliation":[{"name":"Duchesnay; Inc.; Blainville Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart","family":"Macleod","sequence":"additional","affiliation":[{"name":"Department of Pediatrics; The University of British Columbia; Vancouver British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,10,10]]},"reference":[{"key":"10.1002\/jcph.184-BIB0001|jcph184-cit-0001","volume-title":"Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products","author":"United States Food and Drug Administration","year":"2003"},{"key":"10.1002\/jcph.184-BIB0002|jcph184-cit-0002","volume-title":"Guidance Document-Comparative Bioavailability Standards: Formulations Used for Systemic Effects","author":"Health Canada","year":"2012"},{"key":"10.1002\/jcph.184-BIB0003|jcph184-cit-0003","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1517\/17425255.2012.690394","article-title":"Current regulatory approaches of bioequivalence testing","volume":"8","author":"Karalis","year":"2012","journal-title":"Expert Opin Drug Metab Toxicol."},{"key":"10.1002\/jcph.184-BIB0004|jcph184-cit-0004","doi-asserted-by":"crossref","first-page":"813","DOI":"10.1177\/009286159502900304","article-title":"Women in bioavailability\/bioequivalence trials-A regulatory perspective","volume":"29","author":"Chen","year":"1995","journal-title":"Drug Inf J."},{"key":"10.1002\/jcph.184-BIB0005|jcph184-cit-0005","volume-title":"Health Canada. Bioequivalence Requirements: Critical Dose Drugs","author":"Health Canada","year":"2006"},{"key":"10.1002\/jcph.184-BIB0006|jcph184-cit-0006","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1089\/jwh.2005.14.19","article-title":"Sex and racial differences in pharmacological response: Where is the evidence? Pharmacogenetics, pharmacokinetics, and pharmacodynamics","volume":"14","author":"Anderson","year":"2005","journal-title":"J Womens Health (Larchmt)."},{"key":"10.1002\/jcph.184-BIB0007|jcph184-cit-0007","doi-asserted-by":"crossref","first-page":"349","DOI":"10.2165\/00128071-200102060-00001","article-title":"Do women have more adverse drug reactions","volume":"2","author":"Rademaker","year":"2001","journal-title":"Am J Clin Dermatol."},{"key":"10.1002\/jcph.184-BIB0008|jcph184-cit-0008","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1089\/jwh.2008.0971","article-title":"Participation of women in clinical trials for new drugs approved by the food and drug administration in 2000-2002","volume":"18","author":"Yang","year":"2009","journal-title":"J Womens Health (Larchmt)."},{"key":"10.1002\/jcph.184-BIB0009|jcph184-cit-0009","volume-title":"Zolpidem Containing Products: Drug Safety Communication-FDA Requires Lower Recommended Doses","author":"United States Food and Drug Administration","year":"2013"},{"key":"10.1002\/jcph.184-BIB0010|jcph184-cit-0010","doi-asserted-by":"crossref","first-page":"408","DOI":"10.1080\/10837450902891485","article-title":"Gender and interindividual variability in pharmacokinetics","volume":"41","author":"Nicolas","year":"2009","journal-title":"Drug Metab Rev."},{"key":"10.1002\/jcph.184-BIB0011|jcph184-cit-0011","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1016\/j.ijpharm.2011.04.069","article-title":"Does sex matter? The influence of gender on gastrointestinal physiology and drug delivery","volume":"415","author":"Freire","year":"2011","journal-title":"Int J Pharm."},{"key":"10.1002\/jcph.184-BIB0012|jcph184-cit-0012","doi-asserted-by":"crossref","first-page":"1578","DOI":"10.1016\/S0149-2918(03)80157-1","article-title":"The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs","volume":"25","author":"Borgheini","year":"2003","journal-title":"Clin Ther."},{"key":"10.1002\/jcph.184-BIB0013|jcph184-cit-0013","volume-title":"Draft Guidance Document: Considerations for Inclusion of Women in Clinical Trials and Analysis of Data by Sex","author":"Health Canada","year":"2012"},{"key":"10.1002\/jcph.184-BIB0014|jcph184-cit-0014","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/j.contraception.2011.05.015","article-title":"Bioequivalence study of an oral contraceptive containing ethinylestradiol\/drospirenone\/levomefolate calcium relative to ethinylestradiol\/drospirenone and to levomefolate calcium alone","volume":"85","author":"Blode","year":"2012","journal-title":"Contraception."},{"key":"10.1002\/jcph.184-BIB0015|jcph184-cit-0015","first-page":"651","article-title":"Bioequivalence study of generic tablet formulations containing ethinylestradiol and chlormadinone acetate in healthy female volunteers","volume":"59","author":"Bonn","year":"2009","journal-title":"Arzneimittelforschung."},{"key":"10.1002\/jcph.184-BIB0016|jcph184-cit-0016","first-page":"123","article-title":"Bioavailability study with 2 different levonorgestrel-containing drugs in women","volume":"35","author":"Nassr","year":"1997","journal-title":"Int J Clin Pharmacol Ther."},{"key":"10.1002\/jcph.184-BIB0017|jcph184-cit-0017","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1007\/BF03190042","article-title":"Bioavailability and bioequivalence of etonogestrel from two oral formulations of desogestrel: Cerazette and Liseta","volume":"24","author":"Timmer","year":"1999","journal-title":"Eur J Drug Metab Pharmacokinet."},{"key":"10.1002\/jcph.184-BIB0018|jcph184-cit-0018","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1007\/BF03261921","article-title":"Bioequivalence evaluation of a folate-supplemented oral contraceptive containing ethinylestradiol\/drospirenone\/levomefolate calcium versus ethinylestradiol\/drospirenone and levomefolate calcium alone","volume":"32","author":"Wiesinger","year":"2012","journal-title":"Clin Drug Invest."},{"key":"10.1002\/jcph.184-BIB0019|jcph184-cit-0019","first-page":"245","article-title":"A prospective study of nausea and vomiting during pregnancy","volume":"43","author":"Gadsby","year":"1993","journal-title":"Br J Gen Pract."},{"key":"10.1002\/jcph.184-BIB0020|jcph184-cit-0020","unstructured":""},{"key":"10.1002\/jcph.184-BIB0021|jcph184-cit-0021","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1097\/FTD.0b013e3181ff8bc5","article-title":"Systemic bioavailability and pharmacokinetics of the doxylamine-pyridoxine delayed-release combination (Diclectin)","volume":"33","author":"Gill","year":"2011","journal-title":"Ther Drug Monit."},{"key":"10.1002\/jcph.184-BIB0022|jcph184-cit-0022","doi-asserted-by":"crossref","first-page":"334","DOI":"10.1177\/0091270012445207","article-title":"Comparing the pharmacokinetics of doxylamine\/pyridoxine delayed-release combination in nonpregnant women of reproductive age and women in the first trimester of pregnancy","volume":"53","author":"Matok","year":"2013","journal-title":"J Clin Pharmacol."},{"key":"10.1002\/jcph.184-BIB0023|jcph184-cit-0023","first-page":"e400","article-title":"Pharmacokinetic comparison of a delayed-release combination of doxylamine succinate and pyridoxine hydrocholoride (Diclectin) and oral solutions of these drugs in healthy women of childbearing age","volume":"16","author":"Nulman","year":"2009","journal-title":"Can J Clin Pharmacol."},{"key":"10.1002\/jcph.184-BIB0024|jcph184-cit-0024","volume-title":"Guidance for Industry: Bioanalytical Method Validation","author":"United States Food and Drug Administration","year":"2001"},{"key":"10.1002\/jcph.184-BIB0025|jcph184-cit-0025","volume-title":"Guidance for Industry: Statistical Approaches to Establishing Bioequivalence","author":"United States Food and Drug Administration","year":"2001"},{"key":"10.1002\/jcph.184-BIB0026|jcph184-cit-0026","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1177\/00912700122010735","article-title":"The safety of higher than standard dose of doxylamine-pyridoxine (Diclectin) for nausea and vomiting of pregnancy","volume":"41","author":"Atanackovic","year":"2001","journal-title":"J Clin Pharmacol."},{"key":"10.1002\/jcph.184-BIB0027|jcph184-cit-0027","doi-asserted-by":"crossref","first-page":"830","DOI":"10.1016\/S1701-2163(16)30673-9","article-title":"Diclectin therapy for nausea and vomiting of pregnancy: Effects of optimal dosing","volume":"25","author":"Boskovic","year":"2003","journal-title":"J Obstet Gynaecol Can."},{"key":"10.1002\/jcph.184-BIB0028|jcph184-cit-0028","doi-asserted-by":"crossref","first-page":"510","DOI":"10.1067\/mcp.2000.111184","article-title":"Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics","volume":"68","author":"Chen","year":"2000","journal-title":"Clin Pharmacol Ther."},{"key":"10.1002\/jcph.184-BIB0029|jcph184-cit-0029","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1038\/clpt.2012.233","article-title":"Gender differences in drug bioequivalence: Time to rethink practices","volume":"93","author":"Koren","year":"2013","journal-title":"Clin Pharmacol Ther."},{"key":"10.1002\/jcph.184-BIB0030|jcph184-cit-0030","first-page":"70","article-title":"Comparative study on the bioequivalence of two formulations of pravastatin. Data from a crossover, randomised, open-label bioequivalence study in healthy volunteers","volume":"56","author":"Almeida","year":"2006","journal-title":"Arzneimittelforschung."},{"key":"10.1002\/jcph.184-BIB0031|jcph184-cit-0031","first-page":"414","article-title":"Comparative bioavailability of two formulations of levofloxacin and effect of sex on bioequivalence analysis. Data from a randomised, 2\u2009\u00d7\u20092 crossover trial in healthy volunteers","volume":"55","author":"Almeida","year":"2005","journal-title":"Arzneimittelforschung."},{"key":"10.1002\/jcph.184-BIB0032|jcph184-cit-0032","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1046\/j.1365-2710.1999.00246.x","article-title":"Gender-related differences in pharmacokinetics and their clinical significance","volume":"24","author":"Tanaka","year":"1999","journal-title":"J Clin Pharm Ther."},{"key":"10.1002\/jcph.184-BIB0033|jcph184-cit-0033","doi-asserted-by":"crossref","first-page":"203","DOI":"10.2165\/00003088-199834030-00003","article-title":"Physiological changes during the menstrual cycle and their effects on the pharmacokinetics and pharmacodynamics of drugs","volume":"34","author":"Kashuba","year":"1998","journal-title":"Clin Pharmacokinet."}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.184","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full\/10.1002\/jcph.184","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,14]],"date-time":"2022-07-14T13:02:53Z","timestamp":1657803773000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcph.184"}},"subtitle":["The Journal of Clinical Pharmacology"],"short-title":[],"issued":{"date-parts":[[2013,10,10]]},"references-count":33,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2013,12]]}},"URL":"https:\/\/doi.org\/10.1002\/jcph.184","relation":{},"ISSN":["0091-2700"],"issn-type":[{"value":"0091-2700","type":"print"}],"subject":[],"published":{"date-parts":[[2013,10,10]]}}}