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Combination Products : Regulatory Challenges and Successful Product Development by Venky Gopalaswamy, Smita Gopalaswamy

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  • ISBN-13: 9781420064469
  • Sales Rank: 236,809
  • Pub. Date: April 2008

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part ...  More

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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, Vol. 136 by Carmen Medina (Editor)

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  • ISBN-13: 9780824740788
  • Sales Rank: 558,290
  • Pub. Date: January 2004

Complying with the regulations of the US Food and Drug Administration is more of an art than a science, says Medina (president, Precision Consultants, Inc.). He presents 17 ...  More

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Good Pharmaceutical Manufacturing Practice : Rationale and Compliance by John Sharp

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  • ISBN-13: 9780849319945
  • Pub. Date: August 2004

Bridging the gap between US regulations and European Good Manufacturing Practice guidelines, Sharp (European Journal of Parenteral and Pharmaceutical Sciences) explains the ...  More

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How to Develop and Manage Qualification Protocols for FDA Compliance by Phil Cloud, Cloud Cloud, Cloud Phil

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  • ISBN-13: 9781574910988
  • Pub. Date: August 1999

All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation ...  More

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5.

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Pharmaceutical Process Validation, Vol. 129 by Robert A. Nash (Editor) , James Swarbrick, Alfred H. Wachter (Editor)

Textbook Hardcover - REV

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  • ISBN-13: 9780824708382
  • Sales Rank: 286,758
  • Pub. Date: March 2003

The new edition of this classroom text and desk reference recognizes that pharmaceutical process validation was not an American invention, as many in the field have assumed, ...  More

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6.

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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics by Carmen Medina

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  • ISBN-13: 9780824749798
  • Pub. Date: January 2003

Complying with the regulations of the US Food and Drug Administration is more of an art than a science, says Medina (president, Precision Consultants, Inc.). He presents 17 ...  More

A new copy is not available from Barnes & Noble.com at this time.

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      7.

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      Good Manufacturing Practices for Pharmaceuticals by Sidney H. Willig, Murray M. Tuckerman, William S. Hitchings

      Hardcover - 2nd ed., rev. and expanded

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      • ISBN-13: 9780824716646
      • Pub. Date: September 1982

      A new copy is not available from Barnes & Noble.com at this time.

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        8.

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        Good Manufacturing Practices for Pharmaceuticals : A Plan for Total Quality Control by Sidney H. Willig (Editor)

        Hardcover

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        • ISBN-13: 9780824763091
        • Pub. Date: September 1975

        The book contains no figures.  More

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          9.

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          Good Manufacturing Practices for Pharmaceuticals : A Plan for Total Quality Control by Sidney H. Willig, James R. Stoker

          Hardcover - 3rd ed

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          • ISBN-13: 9780824785949
          • Pub. Date: December 1991

          The book contains no figures.  More

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            10.

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            Good Manufacturing Practices for Pharmaceuticals : A Plan for Total Quality Control, Vol. 78 by Sidney H. Willig, James R. Stoker

            Hardcover - New Edition Due 10/01/2000

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            • ISBN-13: 9780824797706
            • Pub. Date: January 1997

            The book contains no figures.  More

            A new copy is not available from Barnes & Noble.com at this time.

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