Walter W Hauck

Summary

Affiliation: United States Pharmacopeia
Country: USA

Publications

  1. doi request reprint Primary and secondary reference materials for procedures to test the quality of medicines and foods
    Walter W Hauck
    USP Reference Standards Committee, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 1790, USA
    Pharm Res 29:922-31. 2012
  2. pmc Change in criteria for USP dissolution performance verification tests
    Walter W Hauck
    US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, USA
    AAPS PharmSciTech 10:21-6. 2009
  3. doi request reprint Metrologic approaches to setting acceptance criteria: unacceptable and unusual characteristics
    Walter W Hauck
    US Pharmacopeia, Documentary Standards Development, 12601 Twinbrook Parkway, Rockville, MD 20852 1790, United States
    J Pharm Biomed Anal 48:1042-5. 2008
  4. ncbi request reprint Reliability and reproducibility of vertical diffusion cells for determining release rates from semisolid dosage forms
    Walter W Hauck
    US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA
    Pharm Res 24:2018-24. 2007
  5. doi request reprint Establishing new acceptance limits for dissolution performance verification of USPC apparatus 1 and 2 using USPC prednisone tablets reference standard
    Anthony J Destefano
    US Pharmacopeial Convention, Rockville, Maryland 20852, USA
    Pharm Res 28:505-16. 2011
  6. doi request reprint The USP Performance Verification Test, Part II: collaborative study of USP's Lot P Prednisone Tablets
    Maria Glasgow
    United States Pharmacopeia, Rockville, MD 20852, USA
    Pharm Res 25:1110-5. 2008
  7. pmc Dissolution variability: comparison of commercial dosage forms with US Pharmacopeia Lot P Prednisone reference standard tablets--a technical note
    Pallavi Nithyanandan
    United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852 1790, USA
    AAPS PharmSciTech 9:238-42. 2008
  8. doi request reprint Development of a performance verification test for USP apparatus 4
    Joseph W Eaton
    US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852 1790, USA
    Pharm Res 29:345-51. 2012
  9. doi request reprint The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets: quality attributes and experimental variables contributing to dissolution variance
    Gang Deng
    United States Pharmacopeia, Rockville, MD 20852, USA
    Pharm Res 25:1100-9. 2008
  10. doi request reprint Measurement science for food and drug monographs: toward a global system
    William F Koch
    US Pharmacopeial Convention, Rockville, Maryland, USA
    Pharm Res 27:1203-7. 2010

Collaborators

  • Roger L Williams
  • Joseph W Eaton
  • Anthony J Destefano
  • Vinod P Shah
  • Gang Deng
  • Pallavi Nithyanandan
  • Ronald G Manning
  • William F Koch
  • William Brown
  • Samir Z Wahab
  • Maria Glasgow
  • Susan S de Mars
  • Jimmy Munoz
  • Maria J Glasgow
  • Loice C Kikwai
  • Shawn Dressman
  • Erika Stippler
  • Thomas Foster
  • Alyssa J Ashley
  • Mark R Liddell
  • Samir Wahab
  • Stefan Schuber
  • Jimmy M Munoz
  • William E Brown

Detail Information

Publications12

  1. doi request reprint Primary and secondary reference materials for procedures to test the quality of medicines and foods
    Walter W Hauck
    USP Reference Standards Committee, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 1790, USA
    Pharm Res 29:922-31. 2012
    ..This article considers the complexity of monographs and reference materials with a focus on qualifying one reference material relative to another...
  2. pmc Change in criteria for USP dissolution performance verification tests
    Walter W Hauck
    US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, USA
    AAPS PharmSciTech 10:21-6. 2009
    ..This paper describes the new PVT and its criterion and how its acceptance limits are derived from results of a collaborative study, explains a two-stage option for the test, and presents operating characteristics...
  3. doi request reprint Metrologic approaches to setting acceptance criteria: unacceptable and unusual characteristics
    Walter W Hauck
    US Pharmacopeia, Documentary Standards Development, 12601 Twinbrook Parkway, Rockville, MD 20852 1790, United States
    J Pharm Biomed Anal 48:1042-5. 2008
    ..Ultimately, acceptance criteria support the availability of good quality, safe, and effective medicines for patients and consumers...
  4. ncbi request reprint Reliability and reproducibility of vertical diffusion cells for determining release rates from semisolid dosage forms
    Walter W Hauck
    US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA
    Pharm Res 24:2018-24. 2007
    ..g., those of the International Organization for Standardization (ISO) 43-1, which succinctly states that "one of the main uses of proficiency testing schemes is to assess laboratories' ability to perform tests competently."..
  5. doi request reprint Establishing new acceptance limits for dissolution performance verification of USPC apparatus 1 and 2 using USPC prednisone tablets reference standard
    Anthony J Destefano
    US Pharmacopeial Convention, Rockville, Maryland 20852, USA
    Pharm Res 28:505-16. 2011
    ..This report presents the collaborative study data, development of the acceptance limits, and results from supporting work for this Lot...
  6. doi request reprint The USP Performance Verification Test, Part II: collaborative study of USP's Lot P Prednisone Tablets
    Maria Glasgow
    United States Pharmacopeia, Rockville, MD 20852, USA
    Pharm Res 25:1110-5. 2008
    ..For Apparatus 1 and 2, USP provides two reference standard tablets for this purpose. For each new lot of these reference standards, USP conducts a collaborative study...
  7. pmc Dissolution variability: comparison of commercial dosage forms with US Pharmacopeia Lot P Prednisone reference standard tablets--a technical note
    Pallavi Nithyanandan
    United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852 1790, USA
    AAPS PharmSciTech 9:238-42. 2008
  8. doi request reprint Development of a performance verification test for USP apparatus 4
    Joseph W Eaton
    US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852 1790, USA
    Pharm Res 29:345-51. 2012
    ..To evaluate salicylic acid tablets as a candidate reference material in a Performance Verification Test (PVT) when a USP performance test for dissolution (General Chapter <711>) relies on USP Apparatus 4 (flow-through cell)...
  9. doi request reprint The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets: quality attributes and experimental variables contributing to dissolution variance
    Gang Deng
    United States Pharmacopeia, Rockville, MD 20852, USA
    Pharm Res 25:1100-9. 2008
    ..USP has applied metrological principles to aid practitioners in carrying out the dissolution procedure alone and in collaborative studies to facilitate understanding potential sources of variability...
  10. doi request reprint Measurement science for food and drug monographs: toward a global system
    William F Koch
    US Pharmacopeial Convention, Rockville, Maryland, USA
    Pharm Res 27:1203-7. 2010
    ..Application of modern metrologic principles to measurement of food and drug articles expands opportunities to ensure availability of good quality food and drugs in national and international markets...
  11. ncbi request reprint Content uniformity and dose uniformity: current approaches, statistical analyses, and presentation of an alternative approach, with special reference to oral inhalation and nasal drug products
    Roger L Williams
    US Pharmacopeia, Rockville, Maryland 20852, USA
    Pharm Res 19:359-66. 2002
    ..The approach facilitates risk communication to practitioners and patients/consumers, which is impeded with current approaches, and reduces regulatory and compendial burden...
  12. ncbi request reprint Equivalence approaches
    Roger L Williams
    United States Pharmacopeia and Office of Pharmaceutical Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, MD 20852, USA
    Clin Pharmacol Ther 72:229-37. 2002