Selection of Adaptive Designs in Studies of Bioequivalence. Decision Criteria
Adaptive designs can be selected for bioequivalence studies of drugs for which there are no data on the variability of pharmacokinetic parameters (the within-individual variability coefficient, CV intra ). These are designs with prospective plans for modification of volunteer sample size based on an...
Saved in:
| Published in | Pharmaceutical chemistry journal Vol. 57; no. 7; pp. 1080 - 1088 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Springer US
01.10.2023
Springer |
| Subjects | |
| Online Access | Get full text |
Cover
Loading…
| Abstract | Adaptive designs can be selected for bioequivalence studies of drugs for which there are no data on the variability of pharmacokinetic parameters (the within-individual variability coefficient, CV
intra
). These are designs with prospective plans for modification of volunteer sample size based on analysis of the results obtained within the study. The aim of the present work was to analyze the guidelines and protocols for bioequivalence studies with adaptive designs for the validity of selecting such a design for a number of parameters. The results of this retrospective study identified key points and generated a list of shortcomings. The need for a comprehensive literature search for CV
intra
values is noted - selection of an adaptive design is justified if no such a search is run and/or when there are conflicting data. Decision criteria for the selection of adaptive designs in bioequivalence studies are presented. Examples given will unify the approach and avoid mistakes in planning further bioequivalence studies. |
|---|---|
| AbstractList | Adaptive designs can be selected for bioequivalence studies of drugs for which there are no data on the variability of pharmacokinetic parameters (the within-individual variability coefficient, CV
intra
). These are designs with prospective plans for modification of volunteer sample size based on analysis of the results obtained within the study. The aim of the present work was to analyze the guidelines and protocols for bioequivalence studies with adaptive designs for the validity of selecting such a design for a number of parameters. The results of this retrospective study identified key points and generated a list of shortcomings. The need for a comprehensive literature search for CV
intra
values is noted - selection of an adaptive design is justified if no such a search is run and/or when there are conflicting data. Decision criteria for the selection of adaptive designs in bioequivalence studies are presented. Examples given will unify the approach and avoid mistakes in planning further bioequivalence studies. Adaptive designs can be selected for bioequivalence studies of drugs for which there are no data on the variability of pharmacokinetic parameters (the within-individual variability coefficient, CV.sub.intra). These are designs with prospective plans for modification of volunteer sample size based on analysis of the results obtained within the study. The aim of the present work was to analyze the guidelines and protocols for bioequivalence studies with adaptive designs for the validity of selecting such a design for a number of parameters. The results of this retrospective study identified key points and generated a list of shortcomings. The need for a comprehensive literature search for CV.sub.intra values is noted - selection of an adaptive design is justified if no such a search is run and/or when there are conflicting data. Decision criteria for the selection of adaptive designs in bioequivalence studies are presented. Examples given will unify the approach and avoid mistakes in planning further bioequivalence studies. |
| Audience | Academic |
| Author | Goryachev, D. V. Eremenko, N. N. |
| Author_xml | – sequence: 1 givenname: N. N. surname: Eremenko fullname: Eremenko, N. N. email: Eremenkonn2014@gmail.com organization: Scientific Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health, I. M. Sechenov First Moscow State Medical University, Russian Ministry of Health (Sechenov University) – sequence: 2 givenname: D. V. surname: Goryachev fullname: Goryachev, D. V. organization: Scientific Center for Expert Evaluation of Medicinal Products, Russian Ministry of Health |
| BookMark | eNp9kMtKAzEUhoNUsK2-gKsB11NzmZlMlrVeoeKiCu5CmpyUlDZTk2mpb2_GcSOIhJPAyf8dkm-EBr7xgNAlwROCMb-OhGBR5JiyVKLm-fEEDUnJWS4wIwM0xFiQnJT4_QyNYlxjnDBGh-h5ARvQrWt81thsatSudQfIbiG6lY-Z89mi3RsHsbu-cQ187N1BbcBrmKSUdrFDZ8G1EJw6R6dWbSJc_Jxj9HZ_9zp7zOcvD0-z6TzXDIs2F4YsC2C02-qqUkpRSmxRmyUwwhg3WFRgoVC6rEtqqDLEYK4rRcBWdQVsjK76uav0FOm8bdqg9NZFLaecV6KknNCUmvyRSsvA1ukk0LrU_wXQHtChiTGAlbvgtip8SoJl51n2nmXyLL89y2OCWA_FFPYrCHLd7INP3_-P-gJCRoII |
| Cites_doi | 10.1002/cpt.2050 10.1002/bdd.347 10.1002/sim.6487 10.1007/BF03226380 10.1016/j.phrs.2008.09.018 10.12793/tcp.2018.26.1.6 10.1080/10543406.2019.1657143 10.1002/pst.294 10.1177/0091270010382010 10.1111/j.1365-2125.2012.04281.x 10.1002/sim.7614 10.5414/CP202731 10.30895/1991-2919-2018-8-2-92-98 |
| ContentType | Journal Article |
| Copyright | Springer Science+Business Media, LLC, part of Springer Nature 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. COPYRIGHT 2023 Springer |
| Copyright_xml | – notice: Springer Science+Business Media, LLC, part of Springer Nature 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. – notice: COPYRIGHT 2023 Springer |
| DBID | AAYXX CITATION |
| DOI | 10.1007/s11094-023-02987-x |
| DatabaseName | CrossRef |
| DatabaseTitle | CrossRef |
| DatabaseTitleList | |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Medicine Chemistry Pharmacy, Therapeutics, & Pharmacology |
| EISSN | 1573-9031 |
| EndPage | 1088 |
| ExternalDocumentID | A776952712 10_1007_s11094_023_02987_x |
| GroupedDBID | --- -53 -58 -5G -BR -EM -Y2 -~C .86 .VR 06C 06D 0R~ 0VY 123 1N0 1SB 2.D 28- 29O 29~ 2J2 2JN 2JY 2KG 2KM 2LR 2P1 2VQ 2~H 30V 4.4 406 408 409 40D 40E 41~ 53G 5QI 5VS 642 67Z 6NX 8TC 8UJ 95- 95. 95~ 96X AAAVM AABHQ AABYN AAFGU AAHNG AAIAL AAJKR AAKSU AANXM AANZL AAPBV AARHV AARTL AATNV AATVU AAUYE AAWCG AAYFA AAYIU AAYQN AAYTO ABBBX ABBXA ABDBF ABDZT ABECU ABFGW ABFTV ABHLI ABHQN ABJNI ABJOX ABKAS ABKCH ABKTR ABMNI ABMQK ABNWP ABPTK ABQBU ABSXP ABTEG ABTKH ABTMW ABULA ABWNU ABXPI ACBMV ACBRV ACBXY ACBYP ACGFS ACHSB ACHXU ACIGE ACIPQ ACKNC ACMDZ ACMLO ACOKC ACOMO ACSNA ACTTH ACUDM ACVWB ACWMK ADHHG ADHIR ADIMF ADINQ ADKNI ADKPE ADMDM ADOXG ADRFC ADTPH ADURQ ADYFF ADZKW AEBTG AEEQQ AEFIE AEFTE AEGAL AEGNC AEJHL AEJRE AEKMD AENEX AEOHA AEPYU AESKC AESTI AETLH AEVLU AEVTX AEXYK AFAFS AFEXP AFGCZ AFLOW AFNRJ AFQWF AFWTZ AFZKB AGAYW AGDGC AGGBP AGGDS AGJBK AGKHE AGMZJ AGQMX AGWIL AGWZB AGYKE AHAVH AHBYD AHKAY AHSBF AHYZX AIAKS AIIXL AILAN AIMYW AITGF AJBLW AJDOV AJRNO AKQUC ALMA_UNASSIGNED_HOLDINGS ALWAN AMKLP AMXSW AMYLF AMYQR AOCGG ARMRJ ASPBG AVWKF AXYYD AZFZN B-. BA0 BBWZM BDATZ BGNMA CAG COF CS3 CSCUP DDRTE DL5 DNIVK DPUIP EBD EBLON EBS EIOEI EJD ESBYG ESX FEDTE FERAY FFXSO FIGPU FINBP FNLPD FRRFC FSGXE FWDCC G-Y G-Z GGCAI GGRSB GJIRD GNWQR GQ6 GQ7 GQ8 GRRUI GXS HF~ HG6 HMJXF HQYDN HRMNR HVGLF HZ~ IAO IHE IJ- IKXTQ IWAJR IXC IXD IXE IZIGR IZQ I~X I~Z J-C JBSCW JCJTX JZLTJ KDC KOV KOW LAK LLZTM M4Y MA- MK0 N2Q NB0 NDZJH NPVJJ NQJWS NU0 O9- O93 O9G O9I O9J OAM OVD P19 P9N PF0 PT4 PT5 QOK QOR QOS R4E R89 R9I RHV RIG RNI RNS ROL RPX RSV RZC RZE RZK S16 S1Z S26 S27 S28 S3B SAP SCLPG SCM SDE SDH SDM SHX SISQX SJYHP SNE SNPRN SNX SOHCF SOJ SPISZ SRMVM SSLCW STPWE SZ9 SZN T13 T16 TEORI TSG TSK TSV TUC TUS U2A U9L UG4 UNUBA UOJIU UTJUX UZXMN VC2 VFIZW W23 W48 W4F WJK WK8 XU3 YLTOR Z7U Z7V Z7W Z87 Z8O Z8P Z8Q Z91 ZGI ZMTXR ZOVNA ~8M ~A9 ~EX ~KM AACDK AAEOY AAJBT AASML AAYXX ABAKF ACAOD ACDTI ACZOJ AEFQL AEMSY AFBBN AGQEE AGRTI AIGIU AJOOF CITATION H13 |
| ID | FETCH-LOGICAL-c309t-9d1b4e32b4e3866aaa221f48dbe31337d096efe4ac5852d2ad1d07c6a1ef686e3 |
| IEDL.DBID | U2A |
| ISSN | 0091-150X |
| IngestDate | Wed Oct 02 17:16:32 EDT 2024 Tue Oct 01 04:01:13 EDT 2024 Thu Sep 12 16:37:04 EDT 2024 Fri Dec 22 01:40:03 EST 2023 |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 7 |
| Keywords | CV two-stage design bioequivalence coefficient of within-individual variability adaptive design |
| Language | English |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c309t-9d1b4e32b4e3866aaa221f48dbe31337d096efe4ac5852d2ad1d07c6a1ef686e3 |
| PageCount | 9 |
| ParticipantIDs | gale_infotracmisc_A776952712 gale_infotracacademiconefile_A776952712 crossref_primary_10_1007_s11094_023_02987_x springer_journals_10_1007_s11094_023_02987_x |
| PublicationCentury | 2000 |
| PublicationDate | 2023-10-01 |
| PublicationDateYYYYMMDD | 2023-10-01 |
| PublicationDate_xml | – month: 10 year: 2023 text: 2023-10-01 day: 01 |
| PublicationDecade | 2020 |
| PublicationPlace | New York |
| PublicationPlace_xml | – name: New York |
| PublicationTitle | Pharmaceutical chemistry journal |
| PublicationTitleAbbrev | Pharm Chem J |
| PublicationYear | 2023 |
| Publisher | Springer US Springer |
| Publisher_xml | – name: Springer US – name: Springer |
| References | Notes on the design of bioequivalence study: Nirmatrelvir + Ritonavir, Guidance Document (2022). L. Shengjie, G. Jun, Z. Yuling, et al., Int. J. Biostat., 20180105 (2020). PotvinDDilibertiCHauckWPharmaceut. Stat.20087424526210.1002/pst.294 Overview of comments received on Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance, EMACHMP/257298 (2018). U. S. Food and Drug Administration Center for Drug Evaluation. and Research. “The main theme of the conference is Advance Approaches in Discussion of Current Issues & Future Possibilities in Bioavailability and Bioequivalence Studies,” in: 6th World Congress on Bioavailability & Bioequivalence ba / be Studies (2015). MaurerWJonesBChenYStat. Med.2018371587160710.1002/sim.761429462835 Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (2021). B. Yavuz, E. Bilensoy, M. ªumnu, FABAD J. Pharm. Sci., 32, 15 – 22 (2007). Clinical pharmacology and biopharmaceutics review(s), Center for drug evaluation and research (2000). D. Romodanovskii, D. Goryachev, A. Solov’eva, et al., Ved. Nauchn. Tsentr. Ékspert. Sredstv Med. Primenen., 8(2), 92 – 98 (2018). PeiróAMNovalbosJZapaterPPharmacol. Res.2009591626810.1016/j.phrs.2008.09.01818992346 FerrariMPGattiGFattoreCEur. J. Drug Metab. Pharmacokinet.2001262572621:CAS:528:DC%2BD38XhtlKmt7s%3D10.1007/BF0322638011808868 LeeYMakWLooiIInt. J. Clin. Pharmacol. Ther.20175576336381:CAS:528:DC%2BC1cXhvF2htrnP10.5414/CP20273128257283 Guidance Document Conduct and Analysis of Comparative. Bioavailability Studies (2018). LeeJFengKXuMClin. Pharmacol. Ther.20201101323510.1002/cpt.205032940349 ChungIOhJLeeSTransl. Clin. Pharmacol.2018261610.12793/tcp.2018.26.1.6320555416989220 LohitnavyMLohitnavyOChaijittiprasertKArzneimittelforschung200454131341:CAS:528:DC%2BD2cXhtlGmsbs%3D14979606 DenkerALazarusNPorrasAJ. Clin. Pharmacol.20115110143914481:CAS:528:DC%2BC3MXhtlekur%2FL10.1177/009127001038201021148044 Federal Law of the Russian Federation, April 12, 2010, No. 61-FZ “The Circulation of Medicines.” Adaptive Designs for Clinical Trials of Drugs and Biologics. Guidance for Industry, U. S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), November 2019. Rao K. Someswara, Reddy B. PhaniBhushan, K. Srinivasu, et. al., Int. J. Recent Sci. Res., 10(01), 30,218 – 30,233 (2019). NajibNIdkaidekNAdelABiopharm. Drug Dispos.20032451831891:CAS:528:DC%2BD3sXmtV2gt7k%3D10.1002/bdd.34712784317 Sorafenib Film-Coated Tablets 200 mg Product-Specific Bioequivalence Guidance, Committee for Medicinal Products for Human Use (CHMP), EMA / CHMP / 315232 / 2014 (2021). ZhuLSunWJ. Biopharm. Stat.20192977679910.1080/10543406.2019.165714331505986 Public Assessment Report. Decentralized Procedure Claire XL 500 mg Prolonged-release Tablets (2010). Frequent Deficiencies in Bioequivalence Study Protocols, Guidance Document (2020). Product Assessment Report International non-proprietary name: glecaprevir / pibrentasvir, EMA / 449689 (2017). KieserMRauchGStat. Med.2015342403241610.1002/sim.648725809815 Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 85, Approval of the Rules for conducting Bioequivalence Studies of Medicinal Products Within the Framework of the Eurasian Economic Union [in Russian]. European Medicines Agency, Guidance on the Investigation of Bioequivalence (2010). Product Assessment Report International non-proprietary name: dasabuvir, EMEA / H / C / 003837 / 0000 (2014). Product Assessment Report International non-proprietary name: ombitasvir / paritaprevir / ritonavir, EMEA/H/C/003839/0000 (2014). GrahamRHopCBorinMBr. J. Clin. Pharmacol.20127457887961:CAS:528:DC%2BC38XhsVKrtLnK10.1111/j.1365-2125.2012.04281.x224586433495143 W Maurer (2987_CR8) 2018; 37 N Najib (2987_CR21) 2003; 24 M Kieser (2987_CR7) 2015; 34 2987_CR24 2987_CR25 2987_CR23 A Denker (2987_CR22) 2011; 51 2987_CR28 2987_CR29 I Chung (2987_CR5) 2018; 26 2987_CR19 MP Ferrari (2987_CR32) 2001; 26 D Potvin (2987_CR6) 2008; 7 2987_CR1 2987_CR2 2987_CR4 J Lee (2987_CR12) 2020; 110 2987_CR31 2987_CR10 R Graham (2987_CR27) 2012; 74 Y Lee (2987_CR3) 2017; 55 2987_CR30 2987_CR13 2987_CR14 2987_CR11 2987_CR33 2987_CR34 L Zhu (2987_CR9) 2019; 29 2987_CR17 2987_CR18 2987_CR15 AM Peiró (2987_CR26) 2009; 59 2987_CR16 M Lohitnavy (2987_CR20) 2004; 54 |
| References_xml | – ident: 2987_CR10 – ident: 2987_CR33 – ident: 2987_CR2 – volume: 110 start-page: 32 issue: 1 year: 2020 ident: 2987_CR12 publication-title: Clin. Pharmacol. Ther. doi: 10.1002/cpt.2050 contributor: fullname: J Lee – ident: 2987_CR31 – volume: 54 start-page: 31 issue: 1 year: 2004 ident: 2987_CR20 publication-title: Arzneimittelforschung contributor: fullname: M Lohitnavy – ident: 2987_CR29 – volume: 24 start-page: 183 issue: 5 year: 2003 ident: 2987_CR21 publication-title: Biopharm. Drug Dispos. doi: 10.1002/bdd.347 contributor: fullname: N Najib – ident: 2987_CR4 – ident: 2987_CR18 – ident: 2987_CR24 – volume: 34 start-page: 2403 year: 2015 ident: 2987_CR7 publication-title: Stat. Med. doi: 10.1002/sim.6487 contributor: fullname: M Kieser – ident: 2987_CR16 – ident: 2987_CR14 – volume: 26 start-page: 257 year: 2001 ident: 2987_CR32 publication-title: Eur. J. Drug Metab. Pharmacokinet. doi: 10.1007/BF03226380 contributor: fullname: MP Ferrari – volume: 59 start-page: 62 issue: 1 year: 2009 ident: 2987_CR26 publication-title: Pharmacol. Res. doi: 10.1016/j.phrs.2008.09.018 contributor: fullname: AM Peiró – ident: 2987_CR11 – ident: 2987_CR1 – volume: 26 start-page: 6 issue: 1 year: 2018 ident: 2987_CR5 publication-title: Transl. Clin. Pharmacol. doi: 10.12793/tcp.2018.26.1.6 contributor: fullname: I Chung – volume: 29 start-page: 776 year: 2019 ident: 2987_CR9 publication-title: J. Biopharm. Stat. doi: 10.1080/10543406.2019.1657143 contributor: fullname: L Zhu – ident: 2987_CR28 – volume: 7 start-page: 245 issue: 4 year: 2008 ident: 2987_CR6 publication-title: Pharmaceut. Stat. doi: 10.1002/pst.294 contributor: fullname: D Potvin – ident: 2987_CR23 – volume: 51 start-page: 1439 issue: 10 year: 2011 ident: 2987_CR22 publication-title: J. Clin. Pharmacol. doi: 10.1177/0091270010382010 contributor: fullname: A Denker – volume: 74 start-page: 788 issue: 5 year: 2012 ident: 2987_CR27 publication-title: Br. J. Clin. Pharmacol. doi: 10.1111/j.1365-2125.2012.04281.x contributor: fullname: R Graham – volume: 37 start-page: 1587 year: 2018 ident: 2987_CR8 publication-title: Stat. Med. doi: 10.1002/sim.7614 contributor: fullname: W Maurer – ident: 2987_CR17 – ident: 2987_CR25 – ident: 2987_CR19 – volume: 55 start-page: 633 issue: 7 year: 2017 ident: 2987_CR3 publication-title: Int. J. Clin. Pharmacol. Ther. doi: 10.5414/CP202731 contributor: fullname: Y Lee – ident: 2987_CR15 – ident: 2987_CR34 doi: 10.30895/1991-2919-2018-8-2-92-98 – ident: 2987_CR13 – ident: 2987_CR30 |
| SSID | ssj0010032 |
| Score | 2.3309538 |
| Snippet | Adaptive designs can be selected for bioequivalence studies of drugs for which there are no data on the variability of pharmacokinetic parameters (the... |
| SourceID | gale crossref springer |
| SourceType | Aggregation Database Publisher |
| StartPage | 1080 |
| SubjectTerms | Analysis Antimitotic agents Antineoplastic agents Antiviral agents Medicine Methods of Analysis and Process Control Organic Chemistry Pantoprazole Pharmacology/Toxicology Pharmacy Protease inhibitors Structure of Chemical Compounds Valsartan |
| Title | Selection of Adaptive Designs in Studies of Bioequivalence. Decision Criteria |
| URI | https://link.springer.com/article/10.1007/s11094-023-02987-x |
| Volume | 57 |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV3fS8MwED5kA_VFdCrOHyMPog-u0KZpuj520ynKRHCD-VTSJIW9bNNVcP-9l7S1DETwJX1I0sDlktzH3X0HcOkzqgLUDIcr6TpMRqETUYmYJ5I8wiYLbIb36Jk_TNjjNJjWedw22L3ySNqLus5181zDYkuN2xGBsoOGYxONB2YQ14TGP64DVNOCIjzyHLR2pmWmzO__2HiNqjt50yNqH5rhPuyVFiKJiy09gC09b8HOoCrM1oLtUekPb8HVS8E8ve6ScZ1IteqSK_JSc1KvD2H0auvd4CaQRUZiJZbmmiO3Nn5jRWZzUgYUmu7-bKHfP2eog7b-CI4q6vAQUxfBaOwRTIZ348GDU1ZScKTvRrkTKS9l2qem6XEuhKDUy1hPpdpHkBoqBDI600xIRA9UUaE85YaSC09nvMe1fwyN-WKuT4D0AuUzQ5uH85iIwtSTEl-0QKYCkU_G23BTSTRZFoQZSU2NbOSfoPwTK__kqw3XRuiJOU35h5CiTArAtQwvVRKHIaoMDT3ahvONkShzudHdrbYtKU_h6o91T_83_Ax2TZn5IojvHBr5x6e-QGMkTzvQjPu3_aH53r893XWsMn4DjbDXSQ |
| link.rule.ids | 315,783,787,27937,27938,41094,41536,42163,42605,52124,52247 |
| linkProvider | Springer Nature |
| linkToHtml | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV3fS8MwED5EwfkiOhWnU_Mg88EV1rRN18c6HVO3MXCDvYU0SWEv3Vw3cP-9l_5wDETwJS9JG7i7JHfc3fcB3DsuVR5ahsWUbFmuDHwroBJjnkCyAIfYyzq8B0PWm7hvU29aNIWlZbV7mZLMbupts5vdMjC21OQdMVK20HM8MPjqppBvQsOf3AHaaY4RHtgWujvTolXm93_sPEflpbybEs1emu4JHBcuIglznZ7Cnk6qUOmUzGxVOBwUCfEqNEY59PSmScbbTqq0SRpktAWl3pzB4CMjvEEtkHlMQiUW5p4jz1kBR0pmCSkqCs3002yuP9czNMKMgARX5UQ8xBAjGJM9h0n3ZdzpWQWVgiWdVrCyAmVHrnaoGdqMCSEotWO3rSLtYJTqK4xkdKxdITF8oIoKZauWL5mwdczaTDsXsJ_ME30JpO0pxzW4efidKwI_sqXEJ82TkcDQJ2Y1eCwlyhc5YgbfYiMb-XOUP8_kz79q8GCEzs1xWi2FFEVXAO5lgKl46PtoM9S3aQ3qOytR5nJnulmqjRfHMP1j36v_Lb-DSm886PP-6_D9Go4M53xe0VeH_dVyrW_QM1lFt5khfgONddee |
| linkToPdf | http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1LT-MwEB6hIgGXXSggCgV8QHCggcZxnObYLZRnUSVAKifLsR2pQkq7NJWW_fU7zmNLEUJCXHyIndiZGdszmplvAA48RrWPkuFwrZoOU2HghFShzRMqHmIT-1mGd--OXz6y64E_eJPFn0W7ly7JPKfBojQl6elYx6ezxDe3aSFtqfVBotXsoBa5yOyzCiy2L55uzv97ElBqc8Tw0HVQ-RkUiTMff2XuciqP6HkHaXbvdH-CLFech5s8n0zT6ET9fQfm-J1fWoUfhVJK2rkUrcGCSaqw3ClrwVVhqVe44Ktw2M_Brl8b5GGWuzVpkEPSn8Fgv65D7z4rsYN8J6OYtLUc25OVnGUhIxMyTEgRw2i7fw1H5vd0iGKflTzBUXnpH2JLMdhNsgGP3fOHzqVTFG9wlNcMUyfUbsSMR23T4lxKSakbs5aOjId2caDRdjKxYVKhwUI1ldrVzUBx6ZqYt7jxNqGSjBKzBaTla49ZpD58j8kwiFyl8BL1VSTR2Ip5DY5LrolxjtEhZmjMlqwCySoysoo_NTiyjBV2A6cvUskiDwHnslBYoh0EKKU0cGkN6nMjkeZqrrtRclUUG3_yybzbXxu-D0v9s664vbq72YEVW-Q-DyGsQyV9mZpdVIXSaK-Q9n-P5P3A |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Selection+of+Adaptive+Designs+in+Studies+of+Bioequivalence.+Decision+Criteria&rft.jtitle=Pharmaceutical+chemistry+journal&rft.au=Eremenko%2C+N.+N&rft.au=Goryachev%2C+D.+V&rft.date=2023-10-01&rft.pub=Springer&rft.issn=0091-150X&rft.volume=57&rft.issue=7&rft.spage=1080&rft_id=info:doi/10.1007%2Fs11094-023-02987-x&rft.externalDocID=A776952712 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=0091-150X&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=0091-150X&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=0091-150X&client=summon |