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Do Plant Isolates have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is it a Matter of Science versus Compliance?

Guilfoyle DE, Cundell AM. Guilfoyle DE, et al. PDA J Pharm Sci Technol. 2022 Feb 15:pdajpst.2021.012675. doi: 10.5731/pdajpst.2021.012675. Online ahead of print. PDA J Pharm Sci Technol. 2022. PMID: 35169041

2

Comprehensive Evaluation of Compendial USP<71>, BacT/Alert Dual-T, and Bactec FX for Detection of Product Sterility Testing Contaminants.

England MR, Stock F, Gebo JET, Frank KM, Lau AF. England MR, et al. J Clin Microbiol. 2019 Jan 30;57(2):e01548-18. doi: 10.1128/JCM.01548-18. Print 2019 Feb. J Clin Microbiol. 2019. PMID: 30541938 Free PMC article.

3

Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products.

Parveen S, Kaur S, David SA, Kenney JL, McCormick WM, Gupta RK. Parveen S, et al. Vaccine. 2011 Oct 19;29(45):8012-23. doi: 10.1016/j.vaccine.2011.08.055. Epub 2011 Aug 24. Vaccine. 2011. PMID: 21871516

4

Equivalence of quality control strains of microorganisms used in the compendial microbiological tests: are national culture collection strains identical?

Cundell AM, Chatellier S, Schumann P, Lilischkis R. Cundell AM, et al. PDA J Pharm Sci Technol. 2010 Mar-Apr;64(2):137-55. PDA J Pharm Sci Technol. 2010. PMID: 21502014

5

[Performance evaluation of VITEK 2 system in meropenem susceptibility testing of clinical Pseudomonas aeruginosa isolates].

Acuner IC, Bayramoğlu G, Birinci A, Cekiç Cihan C, Bek Y, Durupınar B. Acuner IC, et al. Mikrobiyol Bul. 2011 Jul;45(3):411-21. Mikrobiyol Bul. 2011. PMID: 21935774 Turkish.

6

Culture of Care: Organizational Responsibilities.

Brown MJ, Symonowicz C, Medina LV, Bratcher NA, Buckmaster CA, Klein H, Anderson LC. Brown MJ, et al. In: Weichbrod RH, Thompson GA, Norton JN, editors. Management of Animal Care and Use Programs in Research, Education, and Testing. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2018. Chapter 2. In: Weichbrod RH, Thompson GA, Norton JN, editors. Management of Animal Care and Use Programs in Research, Education, and Testing. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2018. Chapter 2. PMID: 29787190 Free Books & Documents. Review.

7

Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins.

Chung WL, Yin J, Messick S, Saggu M, Tschudi K, Woys A, Rahimi R, Azarias M, Kong C, Kabakoff B. Chung WL, et al. PDA J Pharm Sci Technol. 2020 Sep-Oct;74(5):581-591. doi: 10.5731/pdajpst.2019.010652. Epub 2020 Apr 15. PDA J Pharm Sci Technol. 2020. PMID: 32295862

8

Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods.

Esterman AL, Katiyar A, Krishnamurthy G. Esterman AL, et al. J Pharm Biomed Anal. 2016 Sep 5;128:447-454. doi: 10.1016/j.jpba.2016.06.006. Epub 2016 Jun 7. J Pharm Biomed Anal. 2016. PMID: 27344634

9

Sterility Testing for Cellular Therapies: What Is the Role of the Clinical Microbiology Laboratory?

Gebo JET, Lau AF. Gebo JET, et al. J Clin Microbiol. 2020 Jun 24;58(7):e01492-19. doi: 10.1128/JCM.01492-19. Print 2020 Jun 24. J Clin Microbiol. 2020. PMID: 32321785 Free PMC article. Review.

10

Testing of microbial contamination during the preparation of the radiocompound [⁹⁰Y]DOTATOC for clinical trials: a process validation study by Media Fill approach.

Sirna V, Garaboldi L, Papi S, Martano L, Omodeo Salè E, Paganelli G, Chinol M. Sirna V, et al. Q J Nucl Med Mol Imaging. 2010 Oct;54(5):553-9. Q J Nucl Med Mol Imaging. 2010. PMID: 20927022

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