Vinod P Shah

Vinod P Shah

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Vinod P Shah

Publications by authors named "Vinod P Shah"

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Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.

J Pharm Sci 2019 Jun 8. Epub 2019 Jun 8.

Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.xphs.2019.05.033DOI Listing
June 2019

Report on the AAPS Immunogenicity Guidance Forum.

AAPS J 2019 Apr 16;21(4):55. Epub 2019 Apr 16.

Pharmaceutical Consultant, North Potomac, Maryland, 20878, USA.

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http://link.springer.com/10.1208/s12248-019-0328-8
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http://dx.doi.org/10.1208/s12248-019-0328-8DOI Listing
April 2019

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.

J Pharm Sci 2018 07 20;107(7):1761-1772. Epub 2018 Mar 20.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address:

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https://linkinghub.elsevier.com/retrieve/pii/S00223549183014
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http://dx.doi.org/10.1016/j.xphs.2018.03.009DOI Listing
July 2018

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate.

J Pharm Sci 2017 10 5;106(10):2930-2945. Epub 2017 May 5.

Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address:

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https://linkinghub.elsevier.com/retrieve/pii/S00223549173033
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http://dx.doi.org/10.1016/j.xphs.2017.04.068DOI Listing
October 2017

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.

J Pharm Sci 2017 08 21;106(8):1933-1943. Epub 2017 Apr 21.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.xphs.2017.04.019DOI Listing
August 2017

Commonality between BCS and TCS.

Int J Pharm 2016 Jul 18;509(1-2):35-40. Epub 2016 May 18.

DOLE Pharma LLC, Englewood, NJ, USA.

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http://dx.doi.org/10.1016/j.ijpharm.2016.05.032DOI Listing
July 2016

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin.

J Pharm Sci 2016 Apr 5;105(4):1362-9. Epub 2016 Mar 5.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address:

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http://dx.doi.org/10.1016/j.xphs.2016.01.017DOI Listing
April 2016

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine.

J Pharm Sci 2015 Oct 6;104(10):3289-98. Epub 2015 Jul 6.

Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany.

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http://dx.doi.org/10.1002/jps.24560DOI Listing
October 2015

The similarity question for biologicals and non-biological complex drugs.

Eur J Pharm Sci 2015 Aug 23;76:10-7. Epub 2015 Apr 23.

Dutch Top Institute Pharma, P.O. Box 142, 2300 AC Leiden, The Netherlands.

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http://dx.doi.org/10.1016/j.ejps.2015.04.010DOI Listing
August 2015

A science based approach to topical drug classification system (TCS).

Int J Pharm 2015 Aug 10;491(1-2):21-5. Epub 2015 Jun 10.

University College London School of Pharmacy, London, UK.

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http://dx.doi.org/10.1016/j.ijpharm.2015.06.011DOI Listing
August 2015

Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole.

J Pharm Sci 2014 Dec 13;103(12):3843-3858. Epub 2014 Oct 13.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany. Electronic address:

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http://dx.doi.org/10.1002/jps.24181DOI Listing
December 2014

Progressively reducing regulatory burden.

AAPS J 2014 Jul 17;16(4):621-4. Epub 2014 Apr 17.

, N Potomac, Maryland, 20878, USA,

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http://dx.doi.org/10.1208/s12248-014-9601-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070254PMC
July 2014

Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate.

J Pharm Sci 2014 Jun 1;103(6):1592-600. Epub 2014 May 1.

Department of Clinical Pharmacology, School of Pharmacy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, 84105, Israel.

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http://dx.doi.org/10.1002/jps.23977DOI Listing
June 2014

In vitro and in vivo evaluation of three metronidazole topical products.

Pharm Dev Technol 2014 Mar 30;19(2):194-9. Epub 2013 Jan 30.

Department of Pharmaceutical Physics and Informatics .

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http://www.tandfonline.com/doi/full/10.3109/10837450.2013.76
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http://dx.doi.org/10.3109/10837450.2013.763265DOI Listing
March 2014

Biowaiver monographs for immediate release solid oral dosage forms: piroxicam.

J Pharm Sci 2014 Feb 2;103(2):367-77. Epub 2013 Dec 2.

Sechenov First Moscow State Medical University, Moscow, Russia; Scientific Center for Expertise of Medical Products, Institute of Clinical Pharmacology, Moscow, Russia.

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http://dx.doi.org/10.1002/jps.23799DOI Listing
February 2014

Different pharmaceutical products need similar terminology.

AAPS J 2014 Jan 25;16(1):11-4. Epub 2013 Sep 25.

Department of Pharmaceutical Sciences, Utrecht University, P.O. Box 80.082, 3508 TB, Utrecht, The Netherlands.

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http://dx.doi.org/10.1208/s12248-013-9532-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889525PMC
January 2014

How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider.

AAPS J 2014 Jan 25;16(1):15-21. Epub 2013 Sep 25.

Department of Pharmaceutical Sciences, Utrecht University, P.O. Box 80.082, 3508 TB, Utrecht, The Netherlands,

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http://dx.doi.org/10.1208/s12248-013-9533-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889532PMC
January 2014

Workshop on the challenges in substitution of nonbiological complex drugs.

Am J Health Syst Pharm 2013 Nov;70(21):1879-80

North Potomac, MD.

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http://dx.doi.org/10.2146/ajhp130141DOI Listing
November 2013

Progressive applications of dissolution, its impact, and implications in the pharmaceutical world.

Authors:
Vinod P Shah

J Pharm Sci 2013 Sep 31;102(9):2895-7. Epub 2013 May 31.

Pharmaceutical Consultant, North Potomac, Maryland 20878, USA.

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http://dx.doi.org/10.1002/jps.23608DOI Listing
September 2013

Biowaiver monographs for immediate release solid oral dosage forms: efavirenz.

J Pharm Sci 2013 Feb 22;102(2):318-29. Epub 2012 Nov 22.

Brazilian Health Surveillance Agency (Anvisa), Division of Bioequivalence, Londrina State University, Londrina, Brazil.

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http://dx.doi.org/10.1002/jps.23380DOI Listing
February 2013

Biowaiver monographs for immediate release solid oral dosage forms: amodiaquine hydrochloride.

J Pharm Sci 2012 Dec 4;101(12):4390-401. Epub 2012 Sep 4.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.

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https://linkinghub.elsevier.com/retrieve/pii/S00223549153129
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http://dx.doi.org/10.1002/jps.23312DOI Listing
December 2012

Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years.

J Pharm Sci 2012 Nov 21;101(11):4075-99. Epub 2012 Aug 21.

School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK.

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http://dx.doi.org/10.1002/jps.23295DOI Listing
November 2012

Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen.

J Pharm Sci 2012 Oct 11;101(10):3593-603. Epub 2012 Jul 11.

Sechenov First Moscow State Medical University, Moscow, Russia.

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http://dx.doi.org/10.1002/jps.23233DOI Listing
October 2012

Biowaiver monograph for immediate-release solid oral dosage forms: acetylsalicylic acid.

J Pharm Sci 2012 Aug 6;101(8):2653-67. Epub 2012 Jun 6.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.

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http://dx.doi.org/10.1002/jps.23212DOI Listing
August 2012

Biowaiver monographs for immediate-release solid oral dosage forms: primaquine phosphate.

J Pharm Sci 2012 Mar 8;101(3):936-45. Epub 2011 Dec 8.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.

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http://dx.doi.org/10.1002/jps.23006DOI Listing
March 2012

Biowaiver monographs for immediate-release solid oral dosage forms: quinine sulfate.

J Pharm Sci 2012 Feb 11;101(2):499-508. Epub 2011 Nov 11.

Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany.

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http://dx.doi.org/10.1002/jps.22810DOI Listing
February 2012

Biowaiver monographs for immediate-release solid oral dosage forms: stavudine.

J Pharm Sci 2012 Jan 15;101(1):10-6. Epub 2011 Sep 15.

Brazilian Health Surveillance Agency, Anvisa, Division of Bioequivalence, Brasilia, Brazil.

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http://dx.doi.org/10.1002/jps.22756DOI Listing
January 2012

Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal Consta.

Int J Pharm 2011 Nov 24;420(2):198-205. Epub 2011 Aug 24.

School of Pharmacy, University of Connecticut, 69 North Eagleville Rd, Unit 3092, Storrs, CT 06269, USA.

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http://linkinghub.elsevier.com/retrieve/pii/S037851731100797
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http://dx.doi.org/10.1016/j.ijpharm.2011.08.035DOI Listing
November 2011

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Eur J Pharm Sci 2011 Nov 16;44(4):506-13. Epub 2011 Sep 16.

Office of Pharmaceutical Science, Center forDrug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.

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http://dx.doi.org/10.1016/j.ejps.2011.09.010DOI Listing
November 2011

Biowaiver monographs for immediate release solid oral dosage forms: metronidazole.

J Pharm Sci 2011 May 19;100(5):1618-27. Epub 2011 Jan 19.

Brazilian Health Surveillance Agency (Anvisa), Division of Bioequivalence, Brasilia, Brazil.

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http://linkinghub.elsevier.com/retrieve/pii/S002235491532160
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http://dx.doi.org/10.1002/jps.22409DOI Listing
May 2011

Biowaiver monographs for immediate release solid oral dosage forms: levofloxacin.

J Pharm Sci 2011 May 21;100(5):1628-36. Epub 2011 Jan 21.

Brazilian Health Surveillance Agency (Anvisa), Division of Bioequivalence, Brazil.

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http://dx.doi.org/10.1002/jps.22413DOI Listing
May 2011

From drug delivery systems to drug release, dissolution, IVIVC, BCS, BDDCS, bioequivalence and biowaivers.

Pharm Res 2010 Sep 16;27(9):2018-29. Epub 2010 Jul 16.

Thriassio General Hospital, Elefsina, Greece.

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http://dx.doi.org/10.1007/s11095-010-0220-9DOI Listing
September 2010

AAPS-FIP summary workshop report: Pharmacogenetics in individualized medicine: methods, regulatory, and clinical applications.

AAPS J 2009 Jun 25;11(2):214-6. Epub 2009 Mar 25.

Department of Pharmaceutical Sciences, School of Pharmacy, Texas Tech University Health Sciences Center, Amarillo, Texas 79106, USA.

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http://dx.doi.org/10.1208/s12248-009-9097-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2691457PMC
June 2009

A standardized mini paddle apparatus as an alternative to the standard paddle.

AAPS PharmSciTech 2008 25;9(4):1179-84. Epub 2008 Nov 25.

Institute of Pharmaceutical Technology, Goethe University Frankfurt, 9 Max von Laue Street, Frankfurt 60438, Germany.

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http://dx.doi.org/10.1208/s12249-008-9161-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628255PMC
April 2009

Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping.

Acta Derm Venereol 2009 ;89(1):33-8

Department of Dermatology and Venereology, University of Copenhagen, Hellerup, Denmark.

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http://dx.doi.org/10.2340/00015555-0562DOI Listing
March 2009

Bioavailability and bioequivalence: focus on physiological factors and variability.

Pharm Res 2008 Aug 13;25(8):1956-62. Epub 2008 Jun 13.

Department of Pharmacy, University of Athens, Athens, Greece.

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http://dx.doi.org/10.1007/s11095-008-9645-9DOI Listing
August 2008

The use of BDDCS in classifying the permeability of marketed drugs.

Pharm Res 2008 Mar 31;25(3):483-8. Epub 2008 Jan 31.

Department of Biopharmaceutical Sciences, University of California San Francisco, 533 Parnassus Avenue, Room U-68, San Francisco, California 94143-0446, USA.

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http://dx.doi.org/10.1007/s11095-007-9523-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3580995PMC
March 2008

Reliability and reproducibility of vertical diffusion cells for determining release rates from semisolid dosage forms.

Pharm Res 2007 Nov 26;24(11):2018-24. Epub 2007 May 26.

US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA.

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http://dx.doi.org/10.1007/s11095-007-9329-xDOI Listing
November 2007

Quantitative bioanalytical methods validation and implementation: best practices for chromatographic and ligand binding assays.

Pharm Res 2007 Oct 26;24(10):1962-73. Epub 2007 Apr 26.

Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland 20857, USA.

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http://dx.doi.org/10.1007/s11095-007-9291-7DOI Listing
October 2007

Conference report: Bio-International 2005.

J Pharm Sci 2007 Apr;96(4):747-54

College of Pharmacy and Medicine, University of Saskatchewan, Saskatoon, SK, Canada.

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http://dx.doi.org/10.1002/jps.20786DOI Listing
April 2007

Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method.

J Invest Dermatol 2007 Jan 27;127(1):170-8. Epub 2006 Jul 27.

Department of Dermatology, University of Copenhagen, Gentofte Hospital, Hellerup, Denmark.

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http://dx.doi.org/10.1038/sj.jid.5700495DOI Listing
January 2007

IV-IVC for topically applied preparations--a critical evaluation.

Authors:
Vinod P Shah

Eur J Pharm Biopharm 2005 Jul;60(2):309-14

Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA.

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http://dx.doi.org/10.1016/j.ejpb.2004.09.015DOI Listing
July 2005

Determination of the formation of the stratum corneum reservoir for two different corticosteroid formulations using tape stripping combined with UV/VIS spectroscopy.

J Dtsch Dermatol Ges 2004 Nov;2(11):914-9

Department of Dermatology, Center of Experimental and Applied Cutaneous Physiology, University Medical Center Charité, Humboldt-University, Berlin, Germany.

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November 2004

Three-stage sequential statistical dissolution testing rules.

J Biopharm Stat 2004 Aug;14(3):757-79

Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA.

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http://dx.doi.org/10.1081/BIP-200025689DOI Listing
August 2004

In vitro release: comparative evaluation of vertical diffusion cell system and automated procedure.

Pharm Dev Technol 2003 ;8(1):97-102

Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA.

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http://dx.doi.org/10.1081/PDT-120017528 DOI Listing
September 2003

Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products.

J Am Acad Dermatol 2003 May;48(5):740-51

Department of Dermatology, University of Utah, Salt Lake City, 84132, USA.

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http://dx.doi.org/10.1067/mjd.2003.175DOI Listing
May 2003

Biopharmaceutics classification system: the scientific basis for biowaiver extensions.

Pharm Res 2002 Jul;19(7):921-5

Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Rockville, Maryland 20857, USA.

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July 2002

Comparison of skin stripping, in vitro release, and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sources.

J Pharm Sci 2002 May;91(5):1312-23

Department of Dermatology, University of Utah School of Medicine, 4B454 SOM, 30 N. 1900 E., Salt Lake City, UT 84132, USA.

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http://dx.doi.org/10.1002/jps.10147DOI Listing
May 2002

Novel metrics to compare dissolution profiles.

Pharm Dev Technol 2002 May;7(2):257-65

Department of Pharmaceutical Sciences, School of Pharmacy, 20 North Pine Street, University of Maryland, Baltimore, MD 21201, USA.

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http://dx.doi.org/10.1081/PDT-120003493 DOI Listing
May 2002