Primary and Secondary Reference Materials for Procedures to Test the Quality of Medicines and Foods
At present a complex global patchwork of private and public monographs and reference materials is variously available to help ensure the quality of medicines and foods. The relationship of these monographs and reference materials, one to another, frequently is inconsistently understood and documente...
Saved in:
| Published in: | Pharmaceutical research Vol. 29; no. 4; pp. 922 - 931 |
|---|---|
| Main Author: | |
| Format: | Journal Article |
| Language: | English |
| Published: |
Boston
Springer US
01-04-2012
Springer Springer Nature B.V |
| Subjects: | |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Abstract | At present a complex global patchwork of private and public monographs and reference materials is variously available to help ensure the quality of medicines and foods. The relationship of these monographs and reference materials, one to another, frequently is inconsistently understood and documented. This article considers the complexity of monographs and reference materials with a focus on qualifying one reference material relative to another. |
|---|---|
| AbstractList | At present a complex global patchwork of private and public monographs and reference materials is variously available to help ensure the quality of medicines and foods. The relationship of these monographs and reference materials, one to another, frequently is inconsistently understood and documented. This article considers the complexity of monographs and reference materials with a focus on qualifying one reference material relative to another. At present a complex global patchwork of private and public monographs and reference materials is variously available to help ensure the quality of medicines and foods. The relationship of these monographs and reference materials, one to another, frequently is inconsistently understood and documented. This article considers the complexity of monographs and reference materials with a focus on qualifying one reference material relative to another.[PUBLICATION ABSTRACT] |
| Author | Hauck, Walter W. |
| AuthorAffiliation | USP Reference Standards Committee, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1790, USA. wh@usp.org |
| AuthorAffiliation_xml | – name: USP Reference Standards Committee, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852-1790, USA. wh@usp.org |
| Author_xml | – sequence: 3 givenname: Walter W. surname: Hauck fullname: Hauck, Walter W. email: wh@usp.org organization: US Pharmacopeial Convention |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25795658$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/22315018$$D View this record in MEDLINE/PubMed |
| BookMark | eNp1kU9LHTEUxUNR6tP2A3RTQqHQzdibTP5MlkWqLSjaqtDdkMnctCPzEk1mFn57M8xrhYKrcMnvnns455DshRiQkHcMjhmA_pwZAyMrYLwC1ehKvyIbJnVdGRC_9sgGNBdVowU7IIc53wFAw4x4TQ44r5kE1myIu0rD1qZHakNPr9HF0C_TT_SYMDikF3bCNNgxUx8TvUrRYT8nzHSK9AbzRKc_SH_MdhymRxo9vcB-cEMowKJ4GmOf35B9XwTw7e49IrenX29OvlXnl2ffT76cV04IMVXKdlx70ADomgaUN7VgHWtAeOl6J8A7JRnvQHboJNbOCWmYNJ3h2ggP9RH5tOrep_gwF2_tdsgOx9EGjHNuS2YgoNxqCvrhP_QuzikUd63hSikppSoQWyGXYs4JfXu_hlWUFjHdrgW0pYB2KaDVZef9Tnjuttj_2_ibeAE-7gCbnR19ssEN-ZmT2kglF46vXC5f4TemZ4cvX38Cxv2d_g |
| CODEN | PHREEB |
| CitedBy_id | crossref_primary_10_1208_s12248_014_9586_7 crossref_primary_10_1016_j_xphs_2018_06_004 crossref_primary_10_1016_j_jpba_2016_03_017 crossref_primary_10_1007_s11094_018_1718_4 crossref_primary_10_1016_j_jpba_2020_113577 crossref_primary_10_1515_pac_2020_0804 crossref_primary_10_1016_j_biologicals_2018_10_004 crossref_primary_10_1007_s11101_019_09625_z |
| Cites_doi | 10.1023/B:PHAM.0000045222.01170.4c 10.1007/s11095-010-0118-6 10.1351/pac199466091903 |
| ContentType | Journal Article |
| Contributor | Rimmer, Catherine A Van Buskirk, Glenn A Cutrera, Michael A Jin, Shaohong Foster, Mary G Akers, James E Mulkerrin, Michael G Williams, Roger L Bristow, Adrian F Gomas, Antony Raj Olsen, Bernard A Davidson, Gigi S De Muth, James E Osterberg, Robert E Gorecki, Dennis K J Block, Lawrence H Huxsoll, Jean F Ebert, Andrew G Wozniak, Timothy J Watters, Robert L Weitzel, Jane Avramovitch, Bianca Reinders, Thomas P Workman, Wesley E Borer, Matthew W Salahudeen, Iffaaz M Singer, Robert R Sturgeon, Ralph E Parente, Ernest Amidon, Gregory E |
| Contributor_xml | – sequence: 1 givenname: Roger L surname: Williams fullname: Williams, Roger L – sequence: 2 givenname: James E surname: Akers fullname: Akers, James E – sequence: 3 givenname: Gregory E surname: Amidon fullname: Amidon, Gregory E – sequence: 4 givenname: Lawrence H surname: Block fullname: Block, Lawrence H – sequence: 5 givenname: Matthew W surname: Borer fullname: Borer, Matthew W – sequence: 6 givenname: Michael A surname: Cutrera fullname: Cutrera, Michael A – sequence: 7 givenname: Gigi S surname: Davidson fullname: Davidson, Gigi S – sequence: 8 givenname: James E surname: De Muth fullname: De Muth, James E – sequence: 9 givenname: Andrew G surname: Ebert fullname: Ebert, Andrew G – sequence: 10 givenname: Mary G surname: Foster fullname: Foster, Mary G – sequence: 11 givenname: Antony Raj surname: Gomas fullname: Gomas, Antony Raj – sequence: 12 givenname: Dennis K J surname: Gorecki fullname: Gorecki, Dennis K J – sequence: 13 givenname: Jean F surname: Huxsoll fullname: Huxsoll, Jean F – sequence: 14 givenname: Michael G surname: Mulkerrin fullname: Mulkerrin, Michael G – sequence: 15 givenname: Bernard A surname: Olsen fullname: Olsen, Bernard A – sequence: 16 givenname: Robert E surname: Osterberg fullname: Osterberg, Robert E – sequence: 17 givenname: Ernest surname: Parente fullname: Parente, Ernest – sequence: 18 givenname: Thomas P surname: Reinders fullname: Reinders, Thomas P – sequence: 19 givenname: Robert R surname: Singer fullname: Singer, Robert R – sequence: 20 givenname: Glenn A surname: Van Buskirk fullname: Van Buskirk, Glenn A – sequence: 21 givenname: Wesley E surname: Workman fullname: Workman, Wesley E – sequence: 22 givenname: Timothy J surname: Wozniak fullname: Wozniak, Timothy J – sequence: 23 givenname: Bianca surname: Avramovitch fullname: Avramovitch, Bianca – sequence: 24 givenname: Adrian F surname: Bristow fullname: Bristow, Adrian F – sequence: 25 givenname: Shaohong surname: Jin fullname: Jin, Shaohong – sequence: 26 givenname: Catherine A surname: Rimmer fullname: Rimmer, Catherine A – sequence: 27 givenname: Iffaaz M surname: Salahudeen fullname: Salahudeen, Iffaaz M – sequence: 28 givenname: Ralph E surname: Sturgeon fullname: Sturgeon, Ralph E – sequence: 29 givenname: Robert L surname: Watters fullname: Watters, Robert L – sequence: 30 givenname: Jane surname: Weitzel fullname: Weitzel, Jane |
| Copyright | Springer Science+Business Media, LLC 2012 2015 INIST-CNRS |
| Copyright_xml | – notice: Springer Science+Business Media, LLC 2012 – notice: 2015 INIST-CNRS |
| CorporateAuthor | USP Reference Standards Committee USP Council of Experts |
| CorporateAuthor_xml | – name: USP Council of Experts – name: USP Reference Standards Committee |
| DBID | IQODW CGR CUY CVF ECM EIF NPM AAYXX CITATION 3V. 7RV 7TK 7X7 7XB 88E 8AO 8FI 8FJ 8FK ABUWG AFKRA BENPR CCPQU FYUFA GHDGH K9. KB0 M0S M1P NAPCQ PQEST PQQKQ PQUKI PRINS 7X8 |
| DOI | 10.1007/s11095-012-0687-7 |
| DatabaseName | Pascal-Francis Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed CrossRef ProQuest Central (Corporate) Nursing & Allied Health Database Neurosciences Abstracts Health & Medical Collection ProQuest Central (purchase pre-March 2016) Medical Database (Alumni Edition) ProQuest Pharma Collection Hospital Premium Collection Hospital Premium Collection (Alumni Edition) ProQuest Central (Alumni) (purchase pre-March 2016) ProQuest Central (Alumni) ProQuest Central UK/Ireland ProQuest Databases ProQuest One Community College Health Research Premium Collection Health Research Premium Collection (Alumni) ProQuest Health & Medical Complete (Alumni) Nursing & Allied Health Database (Alumni Edition) Health & Medical Collection (Alumni Edition) PML(ProQuest Medical Library) Nursing & Allied Health Premium ProQuest One Academic Eastern Edition (DO NOT USE) ProQuest One Academic ProQuest One Academic UKI Edition ProQuest Central China MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) CrossRef ProQuest One Academic Eastern Edition ProQuest Health & Medical Complete (Alumni) ProQuest Central (Alumni Edition) ProQuest One Community College ProQuest Nursing & Allied Health Source ProQuest Hospital Collection Health Research Premium Collection (Alumni) ProQuest Pharma Collection Neurosciences Abstracts ProQuest Central China ProQuest Hospital Collection (Alumni) ProQuest Central Nursing & Allied Health Premium ProQuest Health & Medical Complete Health Research Premium Collection ProQuest Medical Library ProQuest One Academic UKI Edition Health and Medicine Complete (Alumni Edition) ProQuest Nursing & Allied Health Source (Alumni) ProQuest One Academic ProQuest Medical Library (Alumni) ProQuest Central (Alumni) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE ProQuest One Academic Eastern Edition |
| Database_xml | – sequence: 1 dbid: ECM name: MEDLINE url: https://search.ebscohost.com/login.aspx?direct=true&db=cmedm&site=ehost-live sourceTypes: Index Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Pharmacy, Therapeutics, & Pharmacology Medicine |
| EISSN | 1573-904X |
| EndPage | 931 |
| ExternalDocumentID | 2604535021 10_1007_s11095_012_0687_7 22315018 25795658 |
| Genre | Journal Article |
| GroupedDBID | --- -4W -56 -5G -BR -EM -Y2 -~C .86 .VR 06C 06D 0R~ 0VY 123 199 1N0 1SB 2.D 203 28- 29O 29~ 2J2 2JN 2JY 2KG 2KM 2LR 2P1 2VQ 2~H 30V 3SX 3V. 4.4 406 408 409 40D 40E 53G 5QI 5VS 67N 67Z 6NX 78A 7RV 7X7 88E 8AO 8FI 8FJ 8TC 8UJ 95- 95. 95~ 96X AAAVM AABHQ AABYN AAFGU AAHNG AAIAL AAJKR AANXM AANZL AAPBV AARHV AARTL AATNV AATVU AAUYE AAWCG AAYFA AAYIU AAYOK AAYQN AAYTO ABBBX ABBXA ABDZT ABECU ABELW ABFGW ABFTV ABHLI ABHQN ABIPD ABJNI ABJOX ABKAS ABKCH ABKTR ABLJU ABMNI ABMQK ABNWP ABPLI ABPTK ABQBU ABSXP ABTEG ABTHY ABTKH ABTMW ABULA ABUWG ABWNU ABXPI ACBMV ACBRV ACBXY ACBYP ACGFS ACHSB ACHXU ACIGE ACIPQ ACIWK ACKNC ACMDZ ACMLO ACOKC ACOMO ACPRK ACTTH ACVWB ACWMK ADBBV ADHHG ADHIR ADIMF ADINQ ADJJI ADKNI ADKPE ADMDM ADOAH ADOXG ADRFC ADTPH ADURQ ADYFF ADYPR ADZKW AEBTG AEEQQ AEFIE AEFTE AEGAL AEGNC AEJHL AEJRE AEKMD AENEX AEOHA AEPYU AESKC AESTI AETLH AEVLU AEVTX AEXYK AFDYV AFEXP AFGCZ AFKRA AFLOW AFNRJ AFQWF AFRAH AFWTZ AFZKB AGAYW AGDGC AGGBP AGGDS AGJBK AGMZJ AGQMX AGWIL AGWZB AGYKE AHAVH AHBYD AHIZS AHKAY AHMBA AHSBF AHYZX AIAKS AIIXL AILAN AIMYW AITGF AJBLW AJDOV AJRNO AJZVZ AKMHD AKQUC ALMA_UNASSIGNED_HOLDINGS ALWAN AMKLP AMXSW AMYLF AMYQR AOCGG AOSHJ ARMRJ ASPBG AVWKF AXYYD AZFZN B-. BA0 BBWZM BDATZ BENPR BGNMA BKEYQ BPHCQ BVXVI CAG CCPQU COF CS3 CSCUP DDRTE DL5 DNIVK DPUIP DU5 EBD EBLON EBS EIOEI EJD EMOBN EN4 EPAXT ESBYG EX3 F5P FEDTE FERAY FFXSO FIGPU FINBP FNLPD FRRFC FSGXE FWDCC FYUFA G-Y G-Z GGCAI GGRSB GJIRD GNWQR GQ6 GQ7 GQ8 GXS HF~ HG5 HG6 HMCUK HMJXF HQYDN HRMNR HVGLF HZ~ I09 IAO IHE IJ- IKXTQ IMOTQ INH ITM IWAJR IXC IZIGR IZQ I~X I~Z J-C J0Z JBSCW JCJTX JZLTJ KDC KOV KOW KPH L7B LAK LLZTM LSO M1P M4Y MA- MK0 N2Q N9A NAPCQ NB0 NDZJH NPVJJ NQJWS NU0 O9- O93 O9G O9I O9J OAM OVD P19 P2P PF0 PQQKQ PROAC PSQYO PT4 PT5 Q2X QOK QOR QOS R4E R89 R9I RHV RIG RNI RNS ROL RPX RRX RSV RZC RZE RZK S16 S1Z S26 S27 S28 S3A S3B SAP SBL SBY SCLPG SDH SHX SISQX SJYHP SNE SNPRN SNX SOHCF SOJ SPISZ SRMVM SSLCW SSXJD STPWE SV3 SZN T13 T16 TEORI TSG TSK TSV TUC U2A U9L UG4 UKHRP UNUBA UOJIU UTJUX UZXMN VC2 VFIZW W23 W48 WH7 WJK WK6 WK8 WOW YCJ YLTOR Z45 Z5O Z7S Z7U Z7V Z7W Z7X Z81 Z82 Z83 Z84 Z87 Z88 Z8N Z8O Z8P Z8Q Z8R Z8V Z8W Z91 Z92 ZGI ZMTXR ZOVNA ~KM 8W4 ABFLS ADTIX BBAFP H13 IPNFZ IQODW KSO N95 PQEST PQUKI AACDK AAEOY AAJBT AAQLM AASML AAYZH ABAKF ACAOD ACDTI ACZOJ AEFQL AEMSY AFBBN AGQEE AGRTI AIGIU ALIPV CGR CUY CVF ECM EIF NPM AAYXX CITATION 7TK 7XB 8FK K9. PRINS 7X8 |
| ID | FETCH-LOGICAL-c444t-6ab27f0700ec8806f9341b1804f5cdc40fc6512b05bec5e3cc459159b92794f03 |
| IEDL.DBID | AEJHL |
| ISSN | 0724-8741 |
| IngestDate | Fri Oct 25 09:33:40 EDT 2024 Wed Nov 06 08:38:11 EST 2024 Thu Nov 21 21:41:45 EST 2024 Tue Oct 15 23:44:14 EDT 2024 Thu Nov 24 18:36:36 EST 2022 Sat Dec 16 11:59:15 EST 2023 |
| IsDoiOpenAccess | false |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 4 |
| Keywords | standards metrology comparability quality assurance reference materials Quality assurance Pharmaceutical technology Quality Reference Procedure Standard Standards Food |
| Language | English |
| License | CC BY 4.0 |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c444t-6ab27f0700ec8806f9341b1804f5cdc40fc6512b05bec5e3cc459159b92794f03 |
| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
| OpenAccessLink | https://link.springer.com/content/pdf/10.1007/s11095-012-0687-7.pdf |
| PMID | 22315018 |
| PQID | 926665556 |
| PQPubID | 37334 |
| PageCount | 10 |
| ParticipantIDs | proquest_miscellaneous_1000404448 proquest_journals_926665556 crossref_primary_10_1007_s11095_012_0687_7 pubmed_primary_22315018 pascalfrancis_primary_25795658 springer_journals_10_1007_s11095_012_0687_7 |
| PublicationCentury | 2000 |
| PublicationDate | 2012-04-01 |
| PublicationDateYYYYMMDD | 2012-04-01 |
| PublicationDate_xml | – month: 04 year: 2012 text: 2012-04-01 day: 01 |
| PublicationDecade | 2010 |
| PublicationPlace | Boston |
| PublicationPlace_xml | – name: Boston – name: New York, NY – name: United States – name: New York |
| PublicationSubtitle | An Official Journal of the American Association of Pharmaceutical Scientists |
| PublicationTitle | Pharmaceutical research |
| PublicationTitleAbbrev | Pharm Res |
| PublicationTitleAlternate | Pharm Res |
| PublicationYear | 2012 |
| Publisher | Springer US Springer Springer Nature B.V |
| Publisher_xml | – name: Springer US – name: Springer – name: Springer Nature B.V |
| References | Koch, Hauck, de Mars, Williams (CR6) 2010; 27 Williams, Abernethy, Koch, Hauck, Cecil (CR32) 2009; 35 Bhattacharyya, Cecil, Dabbah, Roll, Schuber, Scheinin (CR2) 2004; 21 (CR9) 2008 CR19 (CR26) 2005 (CR16) 2000 Williams, Abernethy, Koch, Hauck, Cecil (CR4) 2009; 35 CR11 (CR17) 2000 (CR12) 2007 (CR7) 2008 Hauck, Koch, Abernethy, Williams (CR29) 2008; 34 (CR27) 2008 Horowitz (CR30) 1994; 66 (CR14) 2011 (CR24) 2010 Hauck, DeStefano, Cecil, Abernethy, Koch, Williams (CR5) 2009; 35 CR3 (CR15) 2002 (CR8) 1997 (CR25) 2009 CR22 Manning, Lane, Dressman, Hauck, Williams (CR31) 2007; 33 Dudzinski (CR1) 2005; 60 (CR28) 2008 (CR21) 2011 (CR13) 2005 (CR18) 1998 (CR20) 2000 (CR10) 2000 (CR23) 1998 16094771 - Food Drug Law J. 2005;60(2):143-260 15553215 - Pharm Res. 2004 Oct;21(10):1725-31 20372993 - Pharm Res. 2010 Jul;27(7):1203-7 RL Williams (687_CR4) 2009; 35 RL Williams (687_CR32) 2009; 35 WHO (687_CR12) 2007 FDA (687_CR17) 2000 W Horowitz (687_CR30) 1994; 66 687_CR11 687_CR3 WF Koch (687_CR6) 2010; 27 International Conference on Harmonization (687_CR26) 2005 USP (687_CR21) 2011 WW Hauck (687_CR29) 2008; 34 WHO (687_CR14) 2011 ISO (687_CR10) 2000 WHO (687_CR13) 2005 International Conference on Harmonization (687_CR28) 2008 Joint Committee for Guides in Metrology (687_CR7) 2008 (687_CR15) 2002 L Bhattacharyya (687_CR2) 2004; 21 International Conference on Harmonization (687_CR25) 2009 European Parliament (687_CR23) 1998 ICH (687_CR20) 2000 687_CR22 FDA (687_CR18) 1998 DM Dudzinski (687_CR1) 2005; 60 WW Hauck (687_CR5) 2009; 35 687_CR19 RG Manning (687_CR31) 2007; 33 ISO (687_CR8) 1997 ISO (687_CR9) 2008 International Conference on Harmonization (687_CR27) 2008 (687_CR16) 2000 World Health Organization and Food and Agriculture Organization of the United Nations (687_CR24) 2010 |
| References_xml | – start-page: 65 year: 2002 ident: CR15 publication-title: Technical Report 902, WHO expert committee on specifications for pharmaceutical preparations. Annex 3, good practices for National Pharmaceutical Control Laboratories – ident: CR22 – year: 2000 ident: CR17 publication-title: Biotechnology inspection guide reference materials and training aids – year: 2009 ident: CR25 publication-title: Q8(R2): Pharmaceutical development – year: 2008 ident: CR27 publication-title: Q10 pharmaceutical quality system – volume: 21 start-page: 1725 issue: 10 year: 2004 end-page: 31 ident: CR2 article-title: The value of USP public standards for therapeutic products publication-title: Pharm Res. doi: 10.1023/B:PHAM.0000045222.01170.4c contributor: fullname: Scheinin – year: 1998 ident: CR18 publication-title: Compliance program guidance manual 7356.002F: Active Pharmaceutical Ingredients (APIs) – year: 2010 ident: CR24 publication-title: Codex Alimentarius, procedure manual – volume: 27 start-page: 1203 issue: 7 year: 2010 end-page: 7 ident: CR6 article-title: Measurement science for food and drug monographs: toward a global system publication-title: Pharm Res. doi: 10.1007/s11095-010-0118-6 contributor: fullname: Williams – ident: CR19 – start-page: 39 year: 2011 end-page: 40 ident: CR21 publication-title: USP 34–NF 29, USP reference standards <11> – volume: 34 start-page: 838 issue: 3 year: 2008 end-page: 42 ident: CR29 article-title: Making sense of trueness, precision, accuracy, and uncertainty publication-title: Pharmacopeial Forum. contributor: fullname: Williams – start-page: 62 year: 2007 ident: CR12 publication-title: Technical Report 943, WHO committee on specifications for pharmaceutical preparations, Annex 3, general guidelines for the establishment, maintenance, and distribution of chemical reference standards – ident: CR3 – volume: 35 start-page: 772 issue: 3 year: 2009 end-page: 8 ident: CR5 article-title: Acceptable, equivalent, or better: approaches for alternatives to official compendial procedures publication-title: Pharmacopeial Forum. contributor: fullname: Williams – year: 2000 ident: CR16 publication-title: Guidance for industry: Analytical procedures and methods validation—Chemistry, manufacturing, and controls documentation – year: 2008 ident: CR7 publication-title: International vocabulary of metrology—Basic and general concepts and associated terms (VIM) – volume: 35 start-page: 765 issue: 3 year: 2009 end-page: 71 ident: CR32 article-title: Performance-based monographs publication-title: Pharmacopeial Forum. contributor: fullname: Cecil – year: 2011 ident: CR14 publication-title: International biological reference preparations – ident: CR11 – year: 1997 ident: CR8 publication-title: Guide 32, calibration in analytical chemistry and use of certified reference materials – year: 1998 ident: CR23 publication-title: Directive 98/79/EC of the European parliament and of the council of 27 October 1998 on diagnostic medical devices, Annex I – year: 2008 ident: CR9 publication-title: Guide 30: 1992/Amd 1:2008, terms and definitions used in connection with reference materials – volume: 60 start-page: 143 issue: 2 year: 2005 end-page: 260 ident: CR1 article-title: Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein–based therapeutics and monoclonal antibodies publication-title: Food Drug Law J. contributor: fullname: Dudzinski – volume: 35 start-page: 765 issue: 3 year: 2009 end-page: 71 ident: CR4 article-title: Performance-based monographs publication-title: Pharmacopeial Forum. contributor: fullname: Cecil – start-page: v year: 2000 ident: CR10 publication-title: Guide 33, uses of certified reference materials – year: 2000 ident: CR20 publication-title: Q7: Good manufacturing practice guide for active pharmaceutical ingredients – year: 2005 ident: CR26 publication-title: Q9: Quality risk management – volume: 66 start-page: 1903 issue: 9 year: 1994 end-page: 11 ident: CR30 article-title: Nomenclature of interlaboratory analytical studies publication-title: Pure Appl Chem. doi: 10.1351/pac199466091903 contributor: fullname: Horowitz – volume: 33 start-page: 1300 year: 2007 end-page: 6 ident: CR31 article-title: The application of uncertainty to USP’s compendial reference standards program: certified reference materials publication-title: Pharmacopeial Forum. contributor: fullname: Williams – start-page: 194 year: 2005 end-page: 5 ident: CR13 publication-title: Technical Report 932, WHO expert committee on biological standardization. Annex 2, recommendations for the preparation, characterization, and establishment of international and other biological reference standards – year: 2008 ident: CR28 publication-title: Q11: Development and manufacture of drug substances – volume-title: Codex Alimentarius, procedure manual year: 2010 ident: 687_CR24 contributor: fullname: World Health Organization and Food and Agriculture Organization of the United Nations – volume-title: Directive 98/79/EC of the European parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices, Annex I year: 1998 ident: 687_CR23 contributor: fullname: European Parliament – start-page: v volume-title: Guide 33, uses of certified reference materials year: 2000 ident: 687_CR10 contributor: fullname: ISO – ident: 687_CR3 – volume-title: Guide 32, calibration in analytical chemistry and use of certified reference materials year: 1997 ident: 687_CR8 contributor: fullname: ISO – volume-title: Guide 30: 1992/Amd 1:2008, terms and definitions used in connection with reference materials year: 2008 ident: 687_CR9 contributor: fullname: ISO – volume: 27 start-page: 1203 issue: 7 year: 2010 ident: 687_CR6 publication-title: Pharm Res. doi: 10.1007/s11095-010-0118-6 contributor: fullname: WF Koch – start-page: 65 volume-title: Technical Report 902, WHO expert committee on specifications for pharmaceutical preparations. Annex 3, good practices for National Pharmaceutical Control Laboratories year: 2002 ident: 687_CR15 – volume-title: Q8(R2): Pharmaceutical development year: 2009 ident: 687_CR25 contributor: fullname: International Conference on Harmonization – volume: 35 start-page: 765 issue: 3 year: 2009 ident: 687_CR32 publication-title: Pharmacopeial Forum. contributor: fullname: RL Williams – volume-title: Biotechnology inspection guide reference materials and training aids year: 2000 ident: 687_CR17 contributor: fullname: FDA – ident: 687_CR11 – volume-title: Compliance program guidance manual 7356.002F: Active Pharmaceutical Ingredients (APIs) year: 1998 ident: 687_CR18 contributor: fullname: FDA – volume: 35 start-page: 765 issue: 3 year: 2009 ident: 687_CR4 publication-title: Pharmacopeial Forum. contributor: fullname: RL Williams – volume-title: Guidance for industry: Analytical procedures and methods validation—Chemistry, manufacturing, and controls documentation year: 2000 ident: 687_CR16 – volume: 33 start-page: 1300 year: 2007 ident: 687_CR31 publication-title: Pharmacopeial Forum. contributor: fullname: RG Manning – volume-title: Q11: Development and manufacture of drug substances year: 2008 ident: 687_CR28 contributor: fullname: International Conference on Harmonization – volume: 34 start-page: 838 issue: 3 year: 2008 ident: 687_CR29 publication-title: Pharmacopeial Forum. contributor: fullname: WW Hauck – start-page: 62 volume-title: Technical Report 943, WHO committee on specifications for pharmaceutical preparations, Annex 3, general guidelines for the establishment, maintenance, and distribution of chemical reference standards year: 2007 ident: 687_CR12 contributor: fullname: WHO – start-page: 39 volume-title: USP 34–NF 29, USP reference standards <11> year: 2011 ident: 687_CR21 contributor: fullname: USP – start-page: 194 volume-title: Technical Report 932, WHO expert committee on biological standardization. Annex 2, recommendations for the preparation, characterization, and establishment of international and other biological reference standards year: 2005 ident: 687_CR13 contributor: fullname: WHO – volume: 21 start-page: 1725 issue: 10 year: 2004 ident: 687_CR2 publication-title: Pharm Res. doi: 10.1023/B:PHAM.0000045222.01170.4c contributor: fullname: L Bhattacharyya – volume-title: Q7: Good manufacturing practice guide for active pharmaceutical ingredients year: 2000 ident: 687_CR20 contributor: fullname: ICH – volume-title: International vocabulary of metrology—Basic and general concepts and associated terms (VIM) year: 2008 ident: 687_CR7 contributor: fullname: Joint Committee for Guides in Metrology – volume: 66 start-page: 1903 issue: 9 year: 1994 ident: 687_CR30 publication-title: Pure Appl Chem. doi: 10.1351/pac199466091903 contributor: fullname: W Horowitz – ident: 687_CR19 – volume: 35 start-page: 772 issue: 3 year: 2009 ident: 687_CR5 publication-title: Pharmacopeial Forum. contributor: fullname: WW Hauck – ident: 687_CR22 – volume-title: Q9: Quality risk management year: 2005 ident: 687_CR26 contributor: fullname: International Conference on Harmonization – volume: 60 start-page: 143 issue: 2 year: 2005 ident: 687_CR1 publication-title: Food Drug Law J. contributor: fullname: DM Dudzinski – volume-title: Q10 pharmaceutical quality system year: 2008 ident: 687_CR27 contributor: fullname: International Conference on Harmonization – volume-title: International biological reference preparations year: 2011 ident: 687_CR14 contributor: fullname: WHO |
| SSID | ssj0008194 |
| Score | 2.1643703 |
| Snippet | At present a complex global patchwork of private and public monographs and reference materials is variously available to help ensure the quality of medicines... |
| SourceID | proquest crossref pubmed pascalfrancis springer |
| SourceType | Aggregation Database Index Database Publisher |
| StartPage | 922 |
| SubjectTerms | Biochemistry Biological and medical sciences Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Food - standards Food quality General pharmacology Humans Medical Law Medical sciences Medicine Perspective Pharmaceutical Preparations - standards Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Pharmacology/Toxicology Pharmacy Quality Control Reference Standards |
| Title | Primary and Secondary Reference Materials for Procedures to Test the Quality of Medicines and Foods |
| URI | https://link.springer.com/article/10.1007/s11095-012-0687-7 https://www.ncbi.nlm.nih.gov/pubmed/22315018 https://www.proquest.com/docview/926665556 https://search.proquest.com/docview/1000404448 |
| Volume | 29 |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://sdu.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1LS8QwEB58XATx_airEkE8qJVum6TtUXSXRVQWXMFbSdLkIrRidw_77530yaIe9Ng2neYx880kk3wFODeSGh6jAYpI4ARFUulKZrTbp0JGItAIgHYpe_QSPr9F9wNLk-O3SxfZ-02TkSyBujvr1vfsYWK7k4CjYYTLsIquh6Fur94OHkaPLf6ijytJo0Kfoq3TfpPL_EnIgjda_xAFdoyp_mjxU8j5LV1aeqHh5n_qvwUbdcxJbisl2YYlne3AxbgirZ5fk0l3Bqu4Jhdk3NFZz3dBjStCCiKylLzY-XNqr1qGWvIkppUaEwyASXnyIJ3hLJ5MczLBdhGMMUnF1TEnuSFPdTq_KCUO8zwt9uB1OJjcjdz61wyuopROXS6kHxqEC08rRABuYvSGsh951DCVKuoZxTGUkB5DHWE6UIqyGCMnGfsIAMYL9mElyzN9CET7yt4MpB8LassgRqQxT30WMBlx5cBlM0TJR9XgpONatp2aYKcmtlOT0IHThUFs30BkwpkgixzoNaOa1NZaJDFGKZwxxh04a5-imdncich0Pivs5xDusO0o4aBShk42xsiWF9GBq2boO9m_VvXoT6V7sOaXumP3DB3DyvRzpk9guUhnp7X-fwHUU_1u |
| link.rule.ids | 315,782,786,27933,27934,41073,42142,48344,48347,48357,49649,49652,49662,52153 |
| linkProvider | Springer Nature |
| linkToHtml | http://sdu.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1LT4QwEJ7oetDE-H7gsybGgy4JC22Bo1E3a3TNJq6Jnkhb2iMY2T3sv3fKY4lRD3oEykCnM1-nTOcD4NxIaniMDigigQsUSaUrmdFujwoZiUAjANpP2YPn8Ok1ur2zNDlBUwtT7nZvUpIlUrfFbj3PVhPbrQQcPSNchCVLdu53YOn69e3tdg7AOMmVrFGhT9HZaa9JZv4k5Mt0tPouCtSMqX5p8VPM-S1fWk5D_fV_dWAD1uqok1xXZrIJCzrbgotRRVs965JxW4VVdMkFGbWE1rNtUKOKkoKILCXPdgWd2qM5Ry0ZikllyARDYFLWHqRTXMeTSU7G2DGCUSap2DpmJDdkWCf0i1JiP8_TYgde-nfjm4Fb_5zBVZTSicuF9EODgOFphRjATYzzoexFHjVMpYp6RnEMJqTH0EqYDpSiLMbYScY-QoDxgl3oZHmm94FoX9mTgfRjQW0bRIk05qnPAiYjrhy4bMYoea86nLRsy1apCSo1sUpNQgdOvozi_A7EJlwLssiBw2ZYk9pfiyTGOIUzxrgDZ_Or6Gg2eyIynU8L-zgEPOw7StirrKGVjVGyZUZ04KoZ-lb2r6968KfWp7A8GA8fk8f7p4dDWPFLO7I7iI6gM_mY6mNYLNLpSe0Mn2tBAa8 |
| linkToPdf | http://sdu.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1LT9wwEB7BIlWVKkoftCkFXKni0BKRTWwnOSEEBFALWomt1Fvk5zFZNdnD_nvGcbIRgh6qHpM4k4w9M57xeD4DfLWSWp6jAopMYIAiqQwlsyacUiEzkRg0gG4p-_o-vfudXVw6mJzToRam2-0-pCR9TYNDaarak4W2J2Ph2zRylcVuWwFHLUk3YcutitEJbJ3dzK-KtTHGCa9DkEpjiopPp0Ni8zkij6amVwvRYC9Zf7zFc_7nk9xpNyUVr_-bmR3Y7r1RcubF5w1smOotHM08nPXqmMzH6qzmmByR2Qh0vXoHauahKoioNLl3kbV2V2vsWnIrWi_gBF1j0tUk6CXG96StyRyZJOh9Eo_isSK1Jbd9or_pKBZ1rZv38Ku4nJ9fh_2hDaGilLYhFzJOLRqSyCi0DdzmOE_KaRZRy5RWNLKKo5MhI4bSw0yiFGU5-lQyj9E02CjZhUlVV-YjEBMrdzORcS6oa4PWQ-dcxyxhMuMqgG_DeJULz3A5ojC7Ti2xU0vXqWUawMGjEV2_gTYLY0SWBbA3DHHZ63FT5ui_cMYYD-DL-ikqoMuqiMrUy8Z9Dg0h8o4UPnjJGGmj9-wQEwP4PojBSPuvv_rpn1ofwovZRVH-vLn7sQcv406M3MaizzBp_yzNPmw2ennQ68UD4GsKRg |
| 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=Primary+and+Secondary+Reference+Materials+for+Procedures+to+Test+the+Quality+of+Medicines+and+Foods&rft.jtitle=Pharmaceutical+research&rft.au=Hauck%2C+Walter+W.&rft.date=2012-04-01&rft.pub=Springer+US&rft.issn=0724-8741&rft.eissn=1573-904X&rft.volume=29&rft.issue=4&rft.spage=922&rft.epage=931&rft_id=info:doi/10.1007%2Fs11095-012-0687-7&rft.externalDocID=10_1007_s11095_012_0687_7 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=0724-8741&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=0724-8741&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=0724-8741&client=summon |