PUBLICATIONS

1969

  1. The Coordination Chemistry of Tantalum (V), Ann Arbor Press, 1969, 48+ pages (master's thesis).
  2. Coordination Compounds of Niobium (V) and Tantalum (V) Chloroalkoxides with Ligands Related to beta-Diketones, Journal of Less-Common Metals, Volume 19 (1969), pages 141-149, with R. C. Johnson et al.
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1974

  1. Computers and Experimental Optimization, Research/Development, Volume 25 (1974), Number 5, Cover and pages 22-24 & 26, with Stanley N. Deming.
  2. Automated Development of Analytical Methods, Ann Arbor Press, 1974, 443+ pages (Ph.D. Dissertation that won a Sigma XI Award for Excellence).
  3. SNIPLEX: Single-Factor Optimization of Response in the Presence of Error, Analytical Chemistry, Volume 46 (1974), Number 11, pages 1476-1481, with Stanley N. Deming.
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1975

  1. DIFFICULTIES IN THE APPLICATION OF SIMPLEX OPTIMIZATION TO ANALYTICAL CHEMISTRY, Analytical Letters, Volume 8 (1975), Number 5, pages 369-376 with Stanley N. Deming and Stephen L. Morgan.
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1984

  1. Laboratory Automation and Information Management, Analytical Instruments and Computers, Volume 1 (1984), pages 45-47.
  2. Laboratory Computerization and Good Laboratory Practice Standards (GLPS), Analytical Instruments and Computers, Volume 2 (1984), pages 14-15.
  3. Quality Assurance and Computerization in the Regulated Laboratory, Computerized Applications in the Laboratory, Volume 2 (1984), pages 298-304.
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1985

  1. Intelligence in Instruments, Instruments & Computers, Volume 3 (1985), pp. 4-5.
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1996

Several 1996 articles in The AOAC International periodical, The Referee, on:

  1. Business and the Laboratory;
  2. Twentieth International Good manufacturing Practices Conference (in two parts);
  3. ISO/IEC Guide 25 and Laboratory Competence;
  4. Safe Handling of Hazardous Materials, Carcinogens and Biohazards.
  5. Altered Dynamics for USP Apparatus 2, Dissolution Technologies, Volume 3 (1996), No. 3, pp. 8-12.
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1997

  1. Bringing a Chinese Bulk Pharmaceutical Chemical Manufacturer Up to FDA Expectations, J. cGMP Compliance, Volume 1 (1997), Number 3 (April), pp. 38-43.
  2. The Future of Validation A Validation Life Cycle Journey, J. Validation Technology, Volume 3 (1997), Number 3 (May), pp. 296-297.
  3. ISO/IEC Guide 25, An International Quality System Standard, and the FDA-Regulated Laboratory, J. cGMP Compliance, Volume 1 (1997), Number 4 (July), pp. 25-35.
  4. Equipment Validation A Logical Approach to the Pharmaceutical Life Cycle Journey - Part I of a Series -, J. Validation Technology, Volume 3 (1997), Number 4 (August), pp. 345-354.
  5. Process Validation for Existing Processes A Logical Approach to the Pharmaceutical Life Cycle Journey - Part II of a Series -, J. Validation Technology, Volume 4 (1997), Number 1 (November), pp. 53-64.
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1998

  1. Process Validation for New Processes A Logical Approach to the Pharmaceutical Life Cycle Journey - Part III of a Series -, J. Validation Technology, Volume 4 (1998), Number 3 (May), pp. 234-242.
  2. A Direct Approach to Determining The Valid Linear Range for A Comparative Method that Uses a Single Standard, Scientific Computing & Automation June 1998, pp. 63-64.
  3. Improving cGMP Training Programs Part One of a Two-part Series , J. cGMP Compliance, Volume 2, 1998, Number 4 (June), pp. 56-63.
  4. Improving cGMP Training Programs Part Two of a Two-part Series , J. cGMP Compliance, Volume 3, 1998, Number 1 (October), pp. 78-85.
  5. Recommended Revisions to Several USP Standards, Pharmacopeial Forum, Volume 24, Number 6, pp. 7343-7348 (November 1998).
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1999

  1. HPLC METHOD DEVELOPMENT AND VALIDATION: A Direct Procedure For Determining An HPLC Method's Linear Through Zero Range, LClGC, 17(1), pp. 46, 48, 50 (January 1999).
  2. An Empirical Algorithm For Dissolution Profile Calculations, Scientific Computing & Instrumentation, March 1999, pp. 76-77.
  3. Process Validation - Establishing the Minimum Process Capability for a Drug-Product Manufacturing Process (Part 1 of 2: The Basics), Pharmaceutical Engineering, 19(6), pp. 8-16, 74-86 (November/December 1999).
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2000

  1. Process Validation - Establishing the Minimum Process Capability for a Drug-Product Manufacturing Process (Part 2 of 2: Content Uniformity Examples and Extension to Other USP Tests), Pharmaceutical Engineering, 20(2), pp. 72-88 (March/April 2000).
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2004

  1. An 'Americam Mystery Disease', Medical Veritas, 1(2), p. 304 (November 2004).
  2. The best medicine that money can buy, Medical Veritas, 1(2), pp. 305-312 (November 2004).
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2005

  1. "Mercury Emissions", August 2005, pp. 4.
  2. "Thimerosal Causes Mercury Poisoning I- A Rebuttal to Dr. Novella's Views", September 2005, pp. 99.
  3. "Thimerosal Causes Mercury Poisoning II - Rebuttal To Dr. Offit's Views", November 2005
  4. "Thimerosal & Mercury Poisoning - Draft Review of CDC's 050922 Q&A on the Flu Vaccines", November 2005
  5. "Fearmongering - Flu Vaccines & Pandemic Scares - Marketing Mercury Poisoning", November 2005
  6. "Thimerosal Causes Mercury Poisoning III - Rebuttal To Dr. Orenstein's Views", November 2005
  7. "Dr_King's Rebuttal to WSJ 051022 Pro Pharma Editorial for S_1873, 'Bioshield II'", November 2005
  8. "Critical assessment of CDC's 'Questions and answers: Thimerosal-containing influenza vaccine,'" Medical Veritas, 2005; 2(2):703-720.
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2006

  1. Thimerosal Causes Mercury Poisoning V - Review Chambers & McIntyre's 'WhenScienceIsNotEnough--' Article (15 February 2006; 82 pages)
  2. Review of HR2863's Pandemic Flu Provisions & PREP_Act (March 2006; 33 pages)
  3. Thimerosal Causes Mercury Poisoning VI - Review Of Pro-Thimerosal Groups' Letter To Congress (March 2006; 15 pages)
  4. Thimerosal Causes Mercury Poisoning VII - Rebuttal to 'Beyond the Headlines: Link still claimed between thimerosal and autism' Rev. 3 (3 July 2006; 28 pages)
  5. Thimerosal Causes Mercury Poisoning VIII - Mercury-poisoning the Public: The case against the Thimerosal-preserved vaccines [a rebuttal to 'Don't ban thimerosal'](30 June 2006; 8 pages)
  6. Commentary: Thimerosal--what the Lister Hill transcript did not clearly state!" Medical Veritas, 2006; 3(1):821-826.
  7. Editorial--Thimerosal: Proven systemic human poison, immunogen and autoimmunogen, and suspect human, proven animal teratogen." Medical Veritas, 2006; 3(1):914-915.
  8. "Thimerosal Causes Mercury Poisoning IX - Immunization Issues [a rebuttal to 'Arsenel of immunizations ---'] (30 July 2006; 21 pages)"
  9. "Thimerosal Causes Mercury Poisoning X - Link Between Thimerosal and Pervasive Developmental Disorders [Draft Rebuttal to Fombonne et al.'s 'Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations'] (23 August 2006; 102 pages)."
  10. "Thimerosal Causes Mercury Poisoning XI - Draft Rebuttal to the Opinions of Peter Hotez and Rosalynn Carter in their article, 'Act could turn the tide on common birth defect' (23 August 2006; 81 pages)."
  11. "Geier DA, King PG, Geier MR. Influenza vaccine: Review of effectiveness of U.S. vaccination program, and policy considerations. J Am Phys & Surg. 2006 Fall; 11(3): 69-74."
  12. "Thimerosal Causes Mercury Poisoning XII - Draft Response to the DHHS Letter Date-stamped 'AUG 25 2006' - The DHHS's Response to 'An Open Letter to the American Public' posted on the Internet on 9 April 2006 (9 September 2006; 60 pages)."
  13. "CoMeD's Petition to FDA for a STAY under 21 CFR Sec 10.35"
  14. "CoMeD Response to FDA Letter Date-Stamped 'DEC 21 2006' (December 24, 2006, 5 pages)"
  15. "CoMeD Review of NJ Dept Health & Senior Services Letter About Influenza Vaccines: Ineffective & A Mercury-poisoning Vector (27 December 2006, 12 pages)"
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2007

  1. "CoMeD's Recommendations for Changes to Revisions Proposed by the NJ Dept Health and Senior Services to N.J.A.C. 8:57-4, Immunization of Pupils in School (24 January 2007; 14 pages)"
  2. "CoMeD Rebuttal to 'For the Good of the Herd,' an op-ed piece by Arthur Allen published online on January 25, 2007 by the New York Times (25 January 2007; 12 pages)"
  3. "Review of Kevin Leitch's Critique of 'Autistic Children Clinically Proven Mercury Poisoned' (17 April 2007, 12 pages)"
  4. "Thimerosal Causes Mercury Poisoning XIII - Rebuttal to an editorial in Nature Neuroscience 2007; 10: 531, 'Silencing debate over autism' (6 May 2007; 18 pages)"
  5. "Thimerosal Causes Mercury Poisoning XIV - Updated Review of 'Another Salvo in the Mercury/Autism Controversy' By Stephan Novella (18 May 2007; 16 pages)"
  6. "The Deadly Panacea: Vaccines, Immunity & Corporate Science, ACRES USA May 2007; 37(5): 56-60"
  7. Critical assessment of an FDA letter concerning a Citizen Petition specifying actions against Thimerosal-containing drugs. Medical Veritas, 2007; 4(1): 1282-1370.
  8. "2007P-0331 Ban Use of Mercury In Medicine, UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic: Initial remarks, signature pages, supporting organizations, outline, and references listing"
  9. "2007P-0331 Ban Use of Mercury In Medicine, UNLESS Proven Toxicologically Safe to the CGMP Standard Sufficiently Nontoxic: Formal Citizen Petition text"
  10. "Thimerosal Causes Mercury Poisoning XV - Mercury Poisoning by Thimerosal in Vaccines - A Rebuttal to the Doublespeak in: 'On Vaccines, Immune to Reason' By Paul Howard (18 October 2007; 19 pages)"
  11. "Thimerosal Causes Mercury Poisoning XVI - No Proof Of Safety for Thimerosal in Vaccines - A Rebuttal to the Doublespeak in: 'Suffer the Little Children' No More By Michael Fumento (29 October 2007; 20 pages)"
  12. "A Rebuttal to the Doublespeak in: 'Parents, officials struggle over right to refuse vaccines' By Logan Molyneux (25 November 2007; 39 pages)"
  13. "A Review of Parental Dilemma: 'To Get Kids Immunized or Not' By Allen Mask, M.D. (28 November 2007; 15 pages)"
  14. "A Review of the Doublespeak in: 'Vaccines and Autism: Myths and Misconceptions' By Steven Novella (18 December 2007; 63 pages)"
  15. "Review of the 'The National Institute of Mental Health Strategic Plan' Draft (21 December 2007; 36 pages)"
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2008

  1. "A Review of: "Vaccinations are still needed for kids By Meg Fisher, MD" (27 January 2008; 27 pages)"
  2. Geier DA, King PG, Sykes LK, Geier MR. RotaTeq vaccine adverse events and policy considerations. Med Sci Monit 2008; 14: PH9-PH16.
  3. "An UPDATED Review of the Doublespeak in:'Vaccines and Autism: Myths and Misconceptions' By Steven Novella (31 March 2008; 75 pages)"
  4. Key realities about autism, vaccines, vaccine-injury compensation, Thimerosal, and autism-related research. Medical Veritas 2008 April; 5(1): 1610-1644, with Gary S. Goldman.
  5. A rebuttal to the doublespeak in "Parents, officials struggle over right to refuse vaccines". Medical Veritas 2008 April; 5(1): 1645-1666.
  6. "A Review of: 'Vaccines and Autism Revisited - The Hannah Poling Case' [An article by Paul A. Offit, M.D. NEJM 2008 May 15; 358: 20] (30 May 2008; 13 pages)"
  7. "A Review of: 'VACCINATIONS Faith Lets Some Kids Skip Shots' [An article by Sandra G. Boodman, Staff Writer, Washington Post, June 10, 2008] (27 June 2008; 15 pages)"
  8. "A Review of: 'Autism Myth Lives On' [An article by Assoc. Prof. Sam Wang, USA Today on-line April 16, 2008] (30 June 2008; 15 pages)"
  9. "A Review of: 'Experts to Discuss One Puzzling Case, as a Second Case Has Arisen' [An article by Gardiner Harris, Reporter, NY Times on-line June 27, 2008] (11 July 2008; 27 pages)"
  10. "A Review of: 'Vaccine safety: genuine concern or a legacy of unfounded skepticism.' Expert Reviews of Vaccines 2008; 7(3): 275-277. Chatterjee A. (27 July 2008; 40 pages)"
  11. "A Review of: 'As Diseases Make Comeback, Why Aren't All Kids Vaccinated?' Popular Mechanics Magazine on-line. Reynolds GH. (30 July 2008; 30 pages)"
  12. "Thimerosal in Vaccines: Inconvenient Reality (29 August 2008; 6 pages)"
  13. "A Draft Review of: 'Florida Governor's Task Force on Autism Spectrum Disorders- Task Force Requests to the Florida DoH', Part 1 (17 October 2008; 68 pages)"
  14. "A Draft Review of: 'Florida Governor's Task Force on Autism Spectrum Disorders- Task Force Requests to the Florida DoH', Part 2 (17 October 2008; 77 pages)"
  15. "A Draft Response To: 'The Position of the New Jersey Department of Health and Senior Services (NJ DHHS) on: The Pending New Jersey Conscientious Exemption Legislation', (5 November 2008; 18 pages)"
  16. "A Draft Response To: 'Vaccines:Separating fact from fiction (28 Nov. 2008; 37 pages)"
  17. Geier DA, King PG, Sykes LK, Geier MR. A comprehensive review of mercury provoked autism. Indian J Med Res 2008; 128: 383-411.
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2009

  1. "A Draft Response To: 'Some parents oppose New Jersey's new flu vaccination law'(28 Jan. 2009; 12 pages)"
  2. "Draft: Proposed Safety Limits For Organic Mercury Exposure And Thoughts On The Mercury Poisoning Of Developing Children (15 March 2009; 5 pages)"
  3. "Mitochondrial Dysfunction, Impaired Oxidative-Reduction Activity, Degeneration, and Death in Human Neuronal and Fetal Cells Induced by Low-Level Exposure to Thimerosal and Other Metal Compounds. Toxicological & Environmental Chemistry 2009; 91: 735-749. with David A.Geier and Mark R. Geier, MD,PhD"
  4. "Draft: Review of the FDA's 'Thimerosal in Vaccines Questions and Answers'" (9 July 2009; 75 pages)"
  5. "Formal Review of the FDA's: 'Thimerosal in Vaccines Questions and Answers (18 July 2009; 76 pages)"
  6. "E-mail: Information quality request seeking corrections (24 July 2009; 3 pages)"
  7. "The 'No Thimerosal-Preserved Vaccines' Lie (12 August 2009; 9 pages)"
  8. "The 'Truth' About The Toxicity Of Thimerosal (12 August 2009; 6 pages)"
  9. "The Rise of Diseases 'Caused' by Sub-acute Hg Poisoning (12 August 2009; 9 pages)"
  10. "Draft Review of the CDC's 'General Questions and Answers on Thimerosal' (25 October 2009, 22 pages)"
  11. "Updated Editorial on Sub-Acute Mercury (Hg) Poisoning By Medicine: The Rise of Diseases 'Caused' by Sub-acute Hg Poisoning via Medicine (29 November 2009, 12 pages)"
  12. "Misleading Mercury-exposure Comparisons: Thimerosal-preserved Flu Shot Versus the Eating of Tuna Fish (29 November 2009, 5 pages)"
  13. "Draft: Why do media report 'the other side' of scientific facts One Scientist's Response!" (25 December 2009; 21 pages)"
  14. "NOTE: CDC's reporting of historical 'autism' incidence and maximum mercury exposure from CDC-recommended vaccination programs" (30 December 2009; 6 pages)"
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2010

  1. One Scientist's Response to: Vaccine Scares, The Worst Ideas of the Decade" (1 January 2010; 15 pages)"
  2. "Draft Review of Michael Fumento's 'The damage done" (28 February 2010; 32 pages)"
  3. "Bruesewitz v. Wyeth: A layperson's abbreviated views: The 7th Amendment to the Constitution of the USA, the National Vaccine Injury Compensation Program (NVICP) [42 U.S.C. § 300aa-10 et seq.], and Wyeth's absolute, nondischargeable duty to prove that its DTP vaccine was safe (2 April 2010; 10 pages)"
  4. "Thimerosal in Vaccines: A 'Profitable' Medical Population-Maiming Agent?" (23 June 2010; 9 pages)"
  5. "Parallels in New Delhi, India: An Epidemic Induced By Added Doses Of Thimerosal-Preserved Vaccines (11 July 2010, 5 pages)"
  6. "Draft Review of recent publications that show Thimerosal-preserved vaccines are major cause of current chronic-condition 'autism' epidemic (25 July 2010; 27 pages)"
  7. "Revised Review of recent publications that show Thimerosal-preserved vaccines are major cause of current chronic-condition 'autism' epidemic (28 July 2010; 27 pages)"
  8. "Draft: FORMAL REVIEW OF: The FDA's '2010-2011 Influenza Season Vaccine Questions and Answers'" (25 August 2010; 32 pages)"
  9. "Draft: REVIEW: Another False 'Whooping Cough Epidemic' Warning: 'California declares whooping cough epidemic - Santa Clara County fears worst year in 50 years' (27 August 2010; 12 pages)"
  10. "Vaccines, Vaccination Programs, and Knowing Misrepresentations (1 October 2010; 18 pages)"
  11. "Thimerosal: Mercury metabolism and distribution in laboratory rats? (December 2010)"
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2011

  1. "The Non-cost-effective Vaccination Program for Neisseria Meningitidis, and Other Vaccination-Program Concerns and Suggestions (28 January 2011; 10 pages)"
  2. "Vaccines and Autism - The Wrong Argument - rev. 1 (24 February 2011; 9 pages)"
  3. Geier DA, Carmody T, Kern JK, King PG, Geier MR. A significant relationship between mercury exposure from dental amalgams and urinary porphyrins: a further assessment of the Casa Pia children's dental amalgam trial. Biometals 2011; 24: 215-224.
  4. Kern JK, Geier DA, Adams JB, Troutman MR, Davis G, King PG, Young JL. Geier MR. Autism severity and muscle strength: a correlation analysis. Res Autism Spectr Disord 2011; 5: 1011-1015
  5. Geier DA, Kern JK, Davis G, King PG, Adams JB, Young JL, Geier MR. A prospective double-blind, randomized clinical trial of Levocarntine to autism spectrum disorders. Med Sci Monit 2011; 17(6): PI15-PI23
  6. "Draft Assessment of 'At last: Ignorance inoculation...' (10 June 2011; 10 pages)"
  7. "Draft Review of: 'The 'Baltimore Sun' Sinks Deep Into Anti-Vaccination Quicksand' (31 July 2011; 30 pages)"
  8. Geier DA, Carmody T, Kern JK, King PG, Geier MR. A dose-dependen relationship between mercury exposure from dental amalgams and urinary mercury levels: a further assessment of the Casa Pia children's dental amalgam trial. Human Exp Toxicol (in press).
  9. "Introduction & A Review of 'Scientific Information Regarding the Use of Thimerosal As a Preservative in Vaccines' (15 September 2011, 69 pages)"
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2012

  1. "A Review of Seth Mnookin's 'The Autism Vaccine Controversy and the Need for Responsible Science Journalism' (27 January 2012, 37 pages)"Rev.1
  2. "A Review of Julie Lyons' 'Vaccines are effective, save many lives' (14 February 2012, 19 pages)"
  3. "A Review of 'My Turn: Immunizations: Critical protection for state's families' (29 February 2012, 19 pages)"
  4. "A Review of 'Public health decisions should be based on science' (9 March 2012; 36 pages)"
  5. "'Falsus in Unum, Falsus in Omnibus' -- A Thimerosal-preserved Vaccine Conundrum" (31 March 2012; 4 pages)"
  6. "Geier DA, Kern JK, King PG, Sykes LK, Geier MR.  An Evaluation of the Role and Treatment of Elevated Male Hormones in Autism Spectrum Disorders. Acta Neurobiol Exp 2012; 72: 1-17"
  7. "Review of 'A time to get tough on vaccine refusal' (27 April 2012; 19 pages)"
  8. "The 'Anything but Mercury' Realities (14 May 2012; 10 pages)"
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WHITE PAPERS

1996

  1. AN APPROACH TO GENERATING ROBUST VALIDATION PROTOCOLS, A GUIDANCE WHITE PAPER, JUNE 1996, pp. 48+.
  2. VALIDATION: A LIFE CYCLE JOURNEY, A DISCUSSION WHITE PAPER, NOVEMBER 1996, pp. 2+.
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1997

  1. IMPROVING CGMP TRAINING PROGRAMS, A WHITE PAPER, NOVEMBER 1997, pp.45+.
  2. METHOD VALIDATION BY EXAMPLE: A LOGICAL APPROACH TO THE PHARMACEUTICAL LIFE CYCLE JOURNEY Part IV of a Series, AN APPROACH WHITE PAPER, DECEMBER 1997.
  3. FORMAL METHOD VALIDATION: A LOGICAL APPROACH TO THE PHARMACEUTICAL LIFE CYCLE JOURNEY Part V of a Series, AN APPROACH WHITE PAPER, DECEMBER 1997.
  4. VALID HPLC METHODS, PART I: PRACTICAL METHOD DEVELOPMENT RECOMMENDATIONS AND INSIGHTS, A GUIDANCE WHITE PAPER, DECEMBER 1997.
  5. VALID HPLC METHODS, PART II: PRACTICAL LINEARITY, LINEAR RANGE, STANDARD PLACEMENT AND LIMITS Recommendations and Insights, A GUIDANCE WHITE PAPER, DECEMBER 1997.
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1998

  1. IN-PROCESS POWDER BLEND SAMPLING AND EVALUATION (AND APPROPRIATE IN-PROCESS AND FINAL RELEASE SPECIFICATIONS), A WHITE PAPER, JANUARY 1998, full version, pp. 87+; abridged version pp. 36+.
  2. THE BASICS OF A QUALITY-DRIVEN QUALITY SYSTEM, A BASIS WHITE PAPER, JANUARY 1998, pp. 14+.
  3. THE BLENDING OF DRY SOLIDS, A REVIEW WHITE PAPER, FEBRUARY 1998, pp.27+.
  4. VALID HPLC METHODS, PART I: PRACTICAL METHOD DEVELOPMENT RECOMMENDATIONS AND INSIGHTS, A WHITE PAPER, FEBRUARY 1998, pp. 12+
  5. VALID HPLC METHODS, PART II, PRACTICAL LINEARITY, LINEAR RANGE, STANDARD PLACEMENT AND LIMITS RECOMMENDATIONS AND INSIGHTS, A WHITE PAPER, FEBRUARY 1998, pp. 12+
  6. LINEARITY AND ANALYTICAL TESTING, A WHITE PAPER, MARCH 1998, pp. 10+
  7. PROCESS VALIDATION: A PHARMACEUTICAL VALIDATION LIFE CYCLE JOURNEY, A White Paper, April 1998, pp. 30+.
  8. HPLC METHOD DEVELOPMENT AND VALIDATION: A Direct Procedure For Determining An HPLC Method's Linear Through Zero Range, A White Paper, April 1998, pp. 7+.
  9. SAMPLING AND TESTING SIZE, FOR IN-PROCESS BLENDS: LEGAL, REGULATORY AND INDUSTRY REALITIES, A Call To Action, A CONDENSED COMPLIANCE WHITE PAPER, MAY 1998, pp.21+.
  10. IN-PROCESS FINAL-BLEND SAMPLING AND EVALUATION (AND APPROPRIATE IN- PROCESS AND FINAL RELEASE SPECIFICATIONS), A COMPLIANCE WHITE PAPER, JUNE 1998, pp. 72+.
  11. THE BLENDING OF DRY SOLIDS II, A REVISED REVIEW WHITE PAPER, JUNE 1998, pp. 36+.
  12. PURITY DETERMINATION FOR PHARMACEUTICAL INGREDIENTS, A Confidential White Paper, June 1998; revised and augmented July 1998, pp. NA.
  13. SCIENTIFICALLY SOUND, A PREREQUISITE FOR COMPLIANCE WITH 21 CFR 211, A White Paper, July 1998, pp. 33.
  14. COMPONENT COMPLEXITY AND FORMULATION, A Concepts White Paper, August 1998, pp. 20+
  15. WEIGHT-PERCENT PURITY DETERMINATION FOR ACTIVE PHARMACEUTICAL INGREDIENTS (APIs), A WHITE PAPER, AUGUST 1998, pp. 30+.
  16. REVIEW OF TORBECK's ARTICLE & LETTER ON VALIDATION AND PROCESS CAPABILITY, A REVIEW WHITE PAPER, OCTOBER 1998, pp. 9.
  17. PHARMACEUTICAL INSPECTION (SAMPLING AND TESTING): VARIABLE PROPERTIES AND INSPECTION FOR COMPLIANCE: The Post-Release And The Release Dichotomy, A WHITE PAPER, DECEMBER 1998, pp. 40+.
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1999

  1. PROCESS VALIDATION: A PHARMACEUTICAL VALIDATION LIFE CYCLE JOURNEY, A Revised White Paper, January 1999, pp. 30+.
  2. PROCESS VALIDATION ESTABLISHING THE MINIMUM PROCESS CAPABILITY FOR A DRUG-PRODUCT MANUFACTURING PROCESS, A WHITE PAPER, JANUARY 1999, pp. 45+.
  3. VALIDATION: Current Regulatory Requirements For Finished Pharmaceuticals [Condensed Version], A CONDENSED WHITE PAPER, FEBRUARY 1999, pp. 17+.
  4. A VALIDATION LEXICON FOR THE PHARMACEUTICAL INDUSTRY, A REFERENCE WHITE PAPER, FEBRUARY 1999, pp. 15+.
  5. GENERATING SCIENTIFICALLY SOUND AND APPROPRIATE ANALYTICAL TEST METHODS FOR VARIABLE FACTORS, A Guidance White Paper, February 1999, pp. 32+.
  6. THE QUALIFICATION OF A CHROMATOGRAPHIC METHOD: A SCIENTIFICALLY SOUND UPDATE OF THE eRviewer Guidance On The Validation of Chromatographic Methods Provided by Center for Drug Evaluation and Research (CDER) in November 1994, A PRACTICAL GUIDANCE WHITE PAPER, MAY 1999, pp. 25+.
  7. PROCESS VALIDATION ESTABLISHING THE MINIMUM PROCESS CAPABILITY FOR A DRUG-PRODUCT MANUFACTURING PROCESS, AN ABRIDGED GUIDANCE WHITE PAPER, AUGUST 1999, pp. 26.
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2001

  1. QUALITY CONTROL AND STATISTICS, A TRAINING WHITE PAPER, JULY 2001, pp. 81+.
  2. SCIENTIFICALLY SOUND, A PREREQUISITE FOR COMPLIANCE WITH 21 CFR 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS, A REVISED COMPLIANCE WHITE PAPER, JULY 2001, pp. 39.
  3. 21 CFR 11, ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, IN OUTLINE FORMAT WITH ANNOTATIONS, A TRAINING AID, AUGUST 2001, pp. 14.
  4. CAPABILITY-RELATED ERROR-DISTRIBUTION TABLES, A TRAINING AID, AUGUST 2001, pp. 2
  5. A REVIEW OF: THE PDA "TECHNICAL REPORT NO. 25, Blend Uniformity Analysis: Validation and In-process Testing," A REVIEW WHITE PAPER, SEPTEMBER 2001, pp. 23.
  6. A CRITIQUE OF: PDA Review Article, "The Compliance and Science of Blend Uniformity Analysis," A REVIEW WHITE PAPER, OCTOBER 2001, pp. 42.
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2002

  1. PURITY NOT ASSAY, A Guidance White Paper, JULY 2002, pp.20.
  2. DRUG PRODUCT UNIFORMITY: VALID COMPARISON OF BLEND TO TABLET CORES RESULTS, A REVISED GUIDANCE WHITE PAPER, SEPTEMBER 2002, pp. 7.
  3. SOUND PHARMACEUTICAL SCIENCE: INSPECTION BY VARIABLES FOR PERCENT NONCONFORMING, A Reference White Paper, NOVEMBER 2002, pp.15 (Abbreviated version pp. 11).
  4. SOUND PHARMACEUTICAL SCIENCE: INSPECTION BY VARIABLES FOR PERCENT NONCONFORMING CASE 1, A Reference White Paper, NOVEMBER 2002, pp.16 (Abbreviated version pp. 11).
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2003

  1. QUALITY CONTROL AND STATISTICS: WITH DETAILED NOTES, A REFERENCE WHITE PAPER, JANUARY 2003, pp. 186+.
  2. GUIDANCE FOR THE INDUSTRY: Critical Data Evaluation And The Investigation Of Out Of Specification (OOS) Test Results From Pharmaceutical Samples, A GUIDANCE WHITE PAPER, JANUARY 2003, pp. 24.
  3. ESTABLISHING THE MINIMUM PROCESS CAPABILITY FOR A DRUG-PRODUCT MANUFACTURING PROCESS, PART 1 OF 2: THE BASICS (REVISED AND UPDATED), A REFERENCE WHITE PAPER, JANUARY 2003, pp. 39.
  4. SELF-CONSISTENT TERMINOLOGY FOR VALIDATION, A PROPOSAL WHITE PAPER, JANUARY 2003, pp. 16.
  5. HPLC METHOD DEVELOPMENT AND VALIDATION: A Direct Procedure For Determining An HPLC Method's Linear Through Zero Range, A REVISED PROCEDURAL WHITE PAPER, JANUARY 2003, pp. 10.
  6. DISSOLUTION RESULTS: Calculation And Accuracy Considerations, A Revised Procedural White Paper, January 2003, pp. 10+.
  7. IN-PROCESS FINAL-BLEND SAMPLING AND EVALUATION (AND APPROPRIATE IN-PROCESS AND FINAL RELEASE SPECIFICATIONS), A REVISED COMPLIANCE WHITE PAPER, FEBRUARY 2003, pp. 109+.
  8. INTRODUCTION TO DISSOLUTION TESTING AS PER THE USP MONOGRAPH FOR DRUG PRODUCTS, USP <711>, AN UPDATED, INTEGRATED, TRAINING AND GUIDANCE WHITE PAPER, FEBRUARY 2003, pp. 54+.
  9. METHOD VALIDATION BY EXAMPLE: A LIFE CYCLE APPROACH TO PHARMACEUTICAL VALIDATION, A REVISED IN-DEPTH APPLICATION WHITE PAPER, FEBRUARY 2003, pp. 46.
  10. ESTABLISHING THE MINIMUM PROCESS CAPABILITY FOR A DRUG-PRODUCT MANUFACTURING PROCESS, PART 2 of 2: Content Uniformity Examples And Extension To Other USP Tests (revised and updated), A REFERENCE WHITE PAPER, MARCH 2003, pp. 23.
  11. CGMP-COMPLIANCE AND BATCH ACCEPTANCE PRACTICES IN THE PHARMACEUTICAL INDUSTRY, A REVISED COMPLIANCE WHITE PAPER, MARCH 2003, pp. 90+
  12. A SCIENTIFIC REVIEW OF PQRI DECEMBER 2002 REPORT, "THE USE OF STRATIFIED SAMPLING OF BLEND AND DOSAGGE UNITS TO DEMONSTRATE ADEQUACY OF MIX FOR POWDER BLENDS," A TECHNICAL REVIEW WHITE PAPER FOR THE FDA, MARCH 2003, pp. 42 w/o Appendices; pp. 87 w both Appendices.
  13. GUIDANCE FOR THE INDUSTRY: CRITICAL DATA EVALUATION AND THE INVESTIGATION OF OUT OF SPECIFICATION (OOS) TEST RESULTS FROM PHARMACEUTICAL SAMPLES, A REVISED GUIDANCE WHITE PAPER, MARCH 2003, pp. 24+
  14. A LIFE-CYCLE APPROACH TO GENERATING CGMP-COMPLIANT VALIDATION PROTOCOLS, A REVISED APPLICATION WHITE PAPER, APRIL 2003, pp. 12+

2004

  1. QUALITY ASSURANCE AND STATISTICS: WITH DETAILED NOTES, A COMPLIANCE PRIMER FOR THE PHARMACEUTICAL INDUSTRY, MARCH 2004, pp. 195.
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