Publications/Presentations

BOOKS

RECENT ADVANCES IN ANALYTICAL CHEMISTRY by Lawrence A. Pachla, Donald L. Reynolds and D. Scott Wright in Pharmacokinetics: Regulatory – Industrial – Academic Perspectives, Peter G. Welling and Francis L. S. Tse, Editors, Marcel Dekker, Inc., New York, New York, 1988, pp. 57-96.

PUBLICATIONS

COMPARISON OF BIOLOGICAL AND CHEMICAL ASSAYS FOR THE QUANTITATION OF RIFAPENTINE IN HUMAN PLASMA, Michael T. Kenny, Donald L. Reynolds, Marcia A. Brackman and Jacqueline K. Dulworth, Diagn. Microbiol. Infect. Dis., 27, 1997, pp. 107-111.

AN INVESTIGATION OF THE DOSE PROPORTIONALITY OF DEFLAZACORT PHARMACOKINETICS, Niranjan Rao, Vijay O. Bhargava, Donald L. Reynolds, Mark G. Eller and Scott J. Weir, Biopharm. Drug Disp., 17, 1996, pp. 753-760.

PHARMACOKINETICS AND PHARMACODYNAMICS OF THE MONOAMINE OXIDASE B INHIBITOR MOFEGILINE ASSESSED DURING A PHASE I DOSE TOLERANCE TRIAL, Maxine Stoltz, Donald Reynolds, Linda Elkins, Daniel Salazar and Scott Weir, Clin. Pharmacol. Ther., 58(3), 1995, pp. 342-353.

QUANTITATIVE DETERMINATION OF 21-HYDROXY-DEFLAZACORT IN HUMAN PLASMA USING GRADIENT SEMI-MICROBORE LIQUID CHROMATOGRAPHY, Donald L. Reynolds, Steve D. Burmaster and Larry S. Eichmeier, Biomed. Chromatogr., 8, 1994, pp. 230-235.

ISOMERIC SEPARATION OF BERAPROST SODIUM USING AN 1-ACID GLYCOPROTEIN COLUMN, Laurie A. Sly, Donald L. Reynolds and Thomas A. Walker, J. Chromatogr., 641, 1993, pp. 249-255.

DETERMINATION OF MDL 201,012 AT FEMTOMOLE/MILLILITRE LEVELS IN HUMAN PLASMA BY LIQUID CHROMATOGRAPHY WITH ELECTROCHEMICAL DETECTION, Donald L. Reynolds, Larry S. Eichmeier and Dennis H. Giesing, Biomed. Chromatogr., 6, 1992, pp. 295-299.

LIQUID CHROMATOGRAPHIC ANALYSIS OF THE ADENOSINE AGONIST PD 117519 IN DOG PLASMA, Donald L. Reynolds and Lawrence A. Pachla, J. Pharm. Biomed. Anal., 9(4), 1991, pp. 345-349.

BIOLOGICAL SAMPLE PREPARATION AND DATA REDUCTION CONCEPTS IN PHARMACEUTICAL ANALYSIS, Elvin L. Johnson, Donald L. Reynolds, D. Scott Wright and Lawrence A. Pachla, J. Chrom. Sci., 26, 1988, pp. 372-379.

ANALYTICAL METHODS FOR MEASURING URIC ACID IN BIOLOGICAL SAMPLES AND FOOD PRODUCTS, Lawrence A. Pachla, Donald L. Reynolds, D. Scott Wright and Peter T. Kissinger, J. Assoc. Off. Anal. Chem., 70(1), 1987, pp. 1-14.

BIOANALYTIC CONSIDERATIONS FOR PHARMACOKINETIC AND BIOPHARMACEUTIC STUDIES, Lawrence A. Pachla, D. Scott Wright and Donald L. Reynolds, J. Clin. Pharmacol., 26(5), 1986, pp. 332-335.

ROBOTIC ANALYSIS OF 3,7-DIMETHOXY-4-PHENYL-N-1H-TETRAZOL-5-YL-4H-FURO-(3,2-b)-INDOLE-2-CARBOXAMIDE IN HUMAN PLASMA, Elvin L. Johnson, Lawrence A. Pachla and Donald L. Reynolds, J. Pharm. Sci., 75(10), 1986, pp. 1003-1005.

A VALIDATED LIQUID CHROMATOGRAPHIC METHOD FOR THE ANTIALLERGY AGENT CI-922 IN DOG AND RAT PLASMA, I. A. Eiseman, D. L. Reynolds, E. L. Johnson, A. C. Daftsios and L. A. Pachla, J. Pharm. Biomed. Anal, 4(4), 1986, pp. 491-496.

COMMENTS ON THE URICASE/ PEROXIDASE-PHENOL-4-AMINOANTIPYRENE REACTION, Lawrence A. Pachla, Donald L. Reynolds and D. Scott Wright, Clin. Chem., 32(1), 1986, pp. 232-233.

ANALYSIS OF 3-(2-ETHYLAMINO-PROPYL-1,2,3,4-TETRAHYDRO-5H-BENZOPYRANO(3,4C)PYRIDIN-5-ONE IN PLASMA BY HPLC COLUMN SWITCHING AFTER DERIVATIZING THE SECONDARY AMINE WITH FLUORESCEIN-6-ISOTHIOCYANATE, Donald L. Reynolds and Lawrence A. Pachla, J. Pharm. Sci., 74(10), 1985, pp. 1091-1094.

METABOLIC DISPOSITION OF THE ANTIALLERGY COMPOUND CI-922 IN LABORATORY ANIMALS, Irene A. Eiseman, Elvin L. Johnson, Donald L. Reynolds, Lawrence A. Pachla and Peter G. Welling, The Pharmacologist, 27, 1985, p. 181.

ANALYTICAL METHODS FOR DETERMINING ASCORBIC ACID IN BIOLOGICAL SAMPLES, FOOD PRODUCTS, AND PHARMACEUTICALS, Lawrence A. Pachla, Donald L. Reynolds and Peter T. Kissinger, J. Assoc. Off. Anal. Chem., 68(1), 1985, pp. 1-12.

FACTORS AFFECTING THE RETENTION OF QUATERNARY AMMONIUM IONS IN REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY, Donald L. Reynolds, Christopher M. Riley, Larry A. Sternson and A. J. Repta, J. Pharm. Biomed. Anal., 1(3), 1983, pp. 347-361.

CATION EXCHANGE CONTRIBUTION TO THE RETENTION OF SPECIFIC QUATERNARY AMMONIUM COMPOUNDS IN REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY, Donald L. Reynolds, A. J. Repta and L. A. Sternson, J. Pharm. Biomed. Anal., 1(3), 1983, pp. 339-346.

PLASMA LEVELS OF 1,4-DIHYDROXY-5,8-bis[(2-[(2-HYDROXYETHYL)-AMINO]-ETHYL)-AMINO]-9,10-ANTHRACENEDIONE DIHYDROCHLORIDE (DHAD) IN HUMANS, Donald L. Reynolds, Kent K. Ulrich, Thomas F. Patton, A. J. Repta, Larry A. Sternson, Mark C. Myron and Sarah A. Taylor, Int. J. Pharm., 9, 1981, pp. 67-71.

CLINICAL ANALYSIS FOR THE ANTINEOPLASTIC AGENT 1,4-DIHYDROXY-5,8-bis[(2-[(2-HYDROXYETHYL)-AMINO]-ETHYL)-AMINO]-9,10-ANTHRACENEDIONE DIHYDROCHLORIDE (NSC 301739) IN PLASMA. APPLICATION OF TEMPERATURE CONTROL TO PROVIDE SELECTIVITY IN PAIRED-ION HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY, Donald L. Reynolds, Larry A. Sternson and A. J. Repta, J. Chromatogr., 222, 1981, pp. 225-240.

PRESENTATIONS

Quantitation of the Synthetic Prostacyclin Beraprost, Total Beraprost and the Active 314d Stereoisomer, D. Schoener, D. W. Armstrong III, D. Reynolds, O. Dang, J. Bruce, C. Gilman and M. Buonarati, Applied Pharmaceutical Analysis Meeting, Baltimore, MD, September 2010

Approaches to Bioanalytical Method Development – Strategies and Applications, Donald L. Reynolds, Invited Speaker, Boulder, CO, August 2008

Extraction Considerations for the Development of Robust Methods, Donald L. Reynolds, Invited Speaker, Boulder, CO, August 2008

LC-MS/MS Matrix Effects – Mechanisms, Sources, Evaluation and Strategies to Minimize, Donald L. Reynolds, Invited Speaker, Virginia Commonwealth University, Richmond, Virginia, January 2008

LC-MS/MS Matrix Effects – Mechanisms, Sources, Evaluation and Strategies to Minimize, Donald L. Reynolds, Invited Speaker, Lotus Clinical Research Academy, Bangalore, India, October 2007

LC-MS/MS Matrix Effects – Mechanisms, Sources, Evaluation and Strategies to Minimize, Donald L. Reynolds, Invited Speaker, Lotus Labs Pvt. Ltd., Bangalore, India, September 2007

HPLC Column Switching – Introduction and Selected Applications, Donald L. Reynolds, Invited Speaker, Lotus Labs Pvt. Ltd., Bangalore, India, July 2007

Introduction to Bioanalysis, Donald L. Reynolds, Invited Speaker, Lotus Clinical Research Academy, Bangalore, India, April, July, September and October 2007

Approaches to Bioanalytical Method Development – Strategies and Applications, Donald L. Reynolds, Invited Speaker, Lotus Clinical Research Academy, Bangalore, India, April, July, September and October 2007

Influence of Silanol Interactions on the Retention of Amine-Containing Analytes on Silica-Based Bonded Phases – Column Chemistry and Selection of the Right Column, Donald L. Reynolds, Invited Speaker, Lotus Clinical Research Academy, Bangalore, India, April, July, September and October 2007

Extraction Considerations for the Development of Robust Methods, Donald L. Reynolds, Invited Speaker, Lotus Clinical Research Academy, Bangalore, India, April, July, September and October 2007

Extraction Development – Considerations for Developing Robust Extraction Methodology, Donald L. Reynolds, Invited Speaker, Lotus Labs Pvt. Ltd., Bangalore, India, March 2007

Influence of Silanol Interactions on the Retention of Amine-Containing Analytes on Silica-Based Bonded Phases, Donald L. Reynolds, Invited Speaker, Lotus Labs Pvt. Ltd., Bangalore, India, March 2007

Strategy for Developing Bioanalytical Methods for Marketed Products, Donald L. Reynolds, Invited Speaker, Lotus Labs Pvt. Ltd., Bangalore, India, December 2006

Bioanalytical Method Development – Strategies and Applications, Donald L. Reynolds, Invited Speaker, Lotus Labs Pvt. Ltd., Bangalore, India, November 2006

Bioanalytical Case Studies, Donald L. Reynolds, Invited Speaker, Panacos Pharmaceuticals, Gaithersburg, MD, May 2004

Bioanalytical Case Studies, Donald L. Reynolds, Invited Speaker, Ricerca Biosciences, Concord, OH, February 2004

Design and Implementation of a Fully Tunable UV/VIS Solid-State Laser-Induced Fluorescence (LIF) Detection System for HPLC Analysis, Donald L. Reynolds, US Bioanalytics Department Seminar, Hoechst Marion Roussel, Kansas City, MO, December 1998

Design and Implementation of a Fully Tunable UV/VIS Solid-State Laser-Induced Fluorescence (LIF) Detection System for HPLC Analysis, Donald L. Reynolds, Invited Speaker, American Association of Pharmaceutical Scientists Annual Meeting, San Francisco, CA, November 1998

Bioanalytical Case Studies, Donald L. Reynolds, Invited Speaker, Pharmaceutical Analysis II Class, The University of Kansas, Department of Pharmaceutical Chemistry, Lawrence, KS, October 1997

Generalized Strategy for Developing Solid Phase Extraction Methods, Donald L. Reynolds, Invited Speaker, The Strategic Method Development Workshop, Marion Merrell Dow, Inc., Kansas City, MO, December 1994

The Isomeric Separation of Beraprost Sodium Using an -1-Acid Glycoprotein Column, T. A. Walker, L. A. Sly and D. L. Reynolds, 4th International Symposium on Chiral Discrimination, Montreal, Canada, September 1993

Development of a Chiral Separation of Beraprost Sodium Using an -1-Acid Glycoprotein Column, L. A. Sly, T. A. Walker and D. L. Reynolds, American Association of Pharmaceutical Scientists Annual Meeting, San Antonio, TX, November 1992

Development of a Chiral Separation of Beraprost Sodium Using an -1-Acid Glycoprotein Column, L. A. Sly, T. A. Walker and D. L. Reynolds, Midwest Regional ACS Meeting, Lawrence, KS, November 1992

Development of a Chiral Separation of Beraprost Sodium Using an -1-Acid Glycoprotein Column, L. A. Sly, T. A. Walker and D. L. Reynolds, HPLC-92, Baltimore, MD, June 1992 A Validated Liquid Chromatographic Assay to Quantitate ML-1012 in Human Plasma at Femtomole Levels, D. L. Reynolds, L. S. Eichmeier and D. H. Giesing, Development Resources Scientific Conference, Marion Merrell Dow, Inc., Kansas City, MO, November 1991

Strategies for Bioanalytical Methods Development, Donald L. Reynolds, Invited Speaker, Department of Pharmaceutical Chemistry Seminar, The University of Kansas, Lawrence, KS, October 1991

A Validated Liquid Chromatographic Assay to Quantitate ML-1012 in Human Plasma at Femtomole Levels, D. L. Reynolds, L. S. Eichmeier and D. H. Giesing, 3rd International Symposium on Pharmaceutical and Biomedical Analysis, Boston, MA, April 1991

Generalized Strategy for Developing Solid Phase Extraction Methods, Donald L. Reynolds, Invited Speaker, Kansas City Chromatography Discussion Group, Kansas City, MO, July 1990

Validated Liquid Chromatographic Assay for the Antiallergy Agent CI-949 in Rat, Dog and Human Plasma, D. L. Reynolds, K. L. Hoffman and L. A. Pachla, American Association of Pharmaceutical Scientists Annual Meeting, Orlando, FL, October 1988

Using Robotics in Pharmacokinetic Studies – Help or Hindrance?, Elvin L. Johnson, Keith L. Hoffman, Donald L. Reynolds and Larry A. Pachla, Eastern Analytical Symposium, New York, NY, October 1988

Application of Robotics for the Unattended Development of Liquid-Solid Extractions and Routine Analysis of Biological Samples, D. L. Reynolds*, E. L. Johnson, K. L. Hoffman and L. A. Pachla, *Invited Speaker, American Midwest Regional Association of Pharmaceutical Scientists Meeting, Chicago, IL, May 1988

Robotic Technology Applied to Pharmacokinetic/Drug Metabolism Studies, Elvin L. Johnson, Donald L. Reynolds and Lawrence A. Pachla, 10th International Symposium on Column Liquid Chromatography, San Francisco, CA, May 1986

Use of a Chronic Intraduodenal Cannula Preparation for Two-Week Toxicity Studies in Rats, Robert Bonczyk, Michelle Roth, Barbara Windsor, Irene Eiseman, Donald Reynolds and Tsun Chang, FASEB, St. Louis, MO, April 1986

Validated HPLC Analysis of the Antiallergy Agent CI-922, I. A. Eiseman, E. L. Johnson, L. A. Pachla, D. L. Reynolds and P. G. Welling, Academy of Pharmaceutical Sciences Annual Meeting, Minneapolis, MN, October 1985

Analysis of the New Bronchodilator 3-[2-(Ethylamino)-propyl]-1,2,3,4-tetrahydro-5H-(1)-benzopyrano(3,4-c)pyridin-5-one (CI-923) in Plasma by Liquid Chromatography Following Derivatization with Fluorescein-6-Isothiocyanate (F6ITC), Donald L. Reynolds and Lawrence A. Pachla, Academy of Pharmaceutical Sciences Annual Meeting, Philadelphia, PA, October 1984

The Retention Behavior of Quaternary and bis-Quaternary Ammonium Compounds in Reversed-Phase HPLC Systems, Donald L. Reynolds, A. J. Repta and L. A. Sternson, Academy of Pharmaceutical Sciences Annual Meeting, San Diego, CA, November 1982

The Retention Behavior of Quaternary and bis-Quaternary Ammonium Compounds in Reversed-Phase HPLC Systems, D. L. Reynolds, A. J. Repta and L. A. Sternson, 6th International Symposium on Column Liquid Chromatography, Cherry Hill, NJ, June 1982

The Effects of Temperature and Ion Pairing on the HPLC Behavior of the Antineoplastic Agent DHAD (NSC 301739), Donald L. Reynolds, L. A. Sternson and A. J. Repta, Academy of Pharmaceutical Sciences Annual Meeting, San Antonio, TX, November 1980

Testimonials

“Dr. Donald Reynolds was associated with Lotus Clinical Research Academy to share his knowledge & experience with students and Faculty members. Don is a thorough professional with excellent subject matter knowledge. He is also a meticulous teacher. His classes on various aspects of bioanalytical techniques were enjoyed thoroughly by everyone. His experience in the field of Bioanalytical Techniques is simply marvelous.”

Dr. Arindam Mukhopadhyay
Dean, Lotus Clinical Research Academy Pvt. Ltd.,
Bangalore, India

“Our company was having issues with ISR and sample reproducibility with a particular bioanalytical method validation. We hired Don to work with our CRO to troubleshoot and solve the problem. He methodically eliminated issues and ultimately resolved the root cause of the problem. With Don’s insight and guidance, the CRO successfully completed the bioanalytical method validation and client sample analysis.”

Sharon Perry
Associate Director, Quality,
ARCA Biopharma, Inc.

“I have worked with Don Reynolds previously as a colleague and now he consults with my company on bioanalytical projects. Don is a thorough professional with excellent subject matter knowledge. He is detail oriented and provides valuable guidance in managing bioanalytical labs, conducting vendor qualification visits, lab audits, data review, and method development. His experience in this area makes him an asset to any group working with him. I have no hesitation in recommending Don as a bioanalytical consultant.”

Annonymous
Head of Clinical Pharmacology/DMPK,
(Pharma Company in Northeastern US)

“As a small company, we needed to ascertain the quality of vendors prior to placing work at their facility because we simply could not afford any mistakes. We hired Don Reynolds Consulting to audit a bioanalytical facility for project that was just re-prioritized and placed on the fast track for development. Don provided us a high quality and thorough assessment of our potential bioanalytical laboratory and provided a clean and concise audit report such that the team felt comfortable with placing the work at the facility. Because we were short staffed and did not have the experience to assess this type of laboratory within our group, it was comforting to know that Don with his years of experience could do this assessment for us, enabling us to make the final decision in a timely manner”

Anonymous
Director Project Coordination
(small biotech in the Boston area)

“I have known and worked with Don for nearly 25 years, in the environments of a big Pharma company, a CRO and as now as an independent consultant. I highly recommend Don because he brings a unique blend of scientific expertise in bioanalytical chemistry, a meticulous work ethic and a high sense of integrity to every job he undertakes.”

Thomas N. Thompson, PhD
President and Principal Consultant
R&D Services Pharma Consulting

“Don has been a mentor and friend of mine for over 10 years. We initially worked closely together for a multinational CRO supporting preclinical and clinical bioanalytical programs for the pharma and biotech industry. Now that my colleagues and I operate our own preclinical CRO, I call on Don as an independent bioanalytical consultant, as my “go to” expert when our clients run into bioanalytical issues – with Don advising on methods development and validation, and sample analysis, and performing technical and quality audits for our clients and us.”

Matthew Frick
Director, Business Development,
Xenometrics, LLC

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