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Items: 1 to 20 of 117

1.

Executive summary: scientific and regulatory challenges of development of probiotics as foods and drugs.

Hoffman FA, Heimbach JT, Sanders ME, Hibberd PL.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S53-7. doi: 10.1086/523342. No abstract available.

2.

Probiotic foods and drugs: impact of US regulatory status on design of clinical trials.

Hibberd PL, Davidson L.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S137-40; discussion S144-51. doi: 10.1086/523321.

3.

Regulation of probiotic substances as ingredients in foods: premarket approval or "generally recognized as safe" notification.

Mattia A, Merker R.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S115-8; discussion S144-51. doi: 10.1086/523329.

4.

Business considerations in the development of probiotics.

Hoffman FA.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S141-3; discussion S144-51. doi: 10.1086/523323.

5.

Clinical research on probiotics: the interface between science and regulation.

Tamayo C.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S101-3; discussion S144-51. doi: 10.1086/523332.

6.

Current marketplace for probiotics: a Japanese perspective.

Amagase H.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S73-5; discussion S144-51. doi: 10.1086/523338.

7.

Probiotics in the United States.

Vanderhoof JA, Young R.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S67-72; discussion S144-51. doi: 10.1086/523339. Review.

8.

Environmental assessment requirements for live biological drugs.

Sutton A.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S112-4; discussion S144-51. doi: 10.1086/523330.

9.

Allergen-free probiotics.

Mogna G, Strozzi GP, Mogna L.

J Clin Gastroenterol. 2008 Sep;42 Suppl 3 Pt 2:S201-4. doi: 10.1097/MCG.0b013e31818063ed. Review.

PMID:
18685500
10.

The importance of guidelines in the development and application of probiotics.

Reid G; Food and Agricultural Organization of the United Nation and the WHO.

Curr Pharm Des. 2005;11(1):11-6. Review.

PMID:
15638748
11.

Development of probiotics as biologic drugs.

Hoffman FA.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S125-7; discussion S144-51. doi: 10.1086/523326.

12.

Probiotics--the friendly bacteria with market potential in global market.

Khan SH, Ansari FA.

Pak J Pharm Sci. 2007 Jan;20(1):76-82. Review.

PMID:
17337434
13.

Probiotics: definition, sources, selection, and uses.

Sanders ME.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S58-61; discussion S144-51. doi: 10.1086/523341.

14.

Science and regulation. Probiotics: finding the right regulatory balance.

Hoffmann DE, Fraser CM, Palumbo FB, Ravel J, Rothenberg K, Rowthorn V, Schwartz J.

Science. 2013 Oct 18;342(6156):314-5. doi: 10.1126/science.1244656. No abstract available. Erratum in: Science. 2013 Nov 8;342(6159):693.

PMID:
24136953
15.

Product development of probiotics as biological drugs.

Sutton A.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S128-32; discussion S144-51. doi: 10.1086/523325.

16.

Regulatory science and the role of the regulator in biomedical innovation.

Honig PK, Huang SM.

Clin Pharmacol Ther. 2012 Mar;91(3):347-52. doi: 10.1038/clpt.2011.352. No abstract available.

PMID:
22343804
17.

Regulating the safety of probiotics--the European approach.

von Wright A.

Curr Pharm Des. 2005;11(1):17-23. Review.

PMID:
15638749
18.

Health-benefit claims for probiotic products.

Heimbach JT.

Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S122-4; discussion S144-51. doi: 10.1086/523327.

19.

Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group.

Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J; PhRMA Working Group.

J Biopharm Stat. 2006 May;16(3):275-83; discussion 285-91, 293-8, 311-2.

PMID:
16724485
20.

Application of evidence on probiotics, prebiotics and synbiotics by food industry: a descriptive study.

Mugambi MN, Young T, Blaauw R.

BMC Res Notes. 2014 Oct 23;7:754. doi: 10.1186/1756-0500-7-754.

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