Selected publications and poster presentations published by ABC Laboratories' scientific staff are available for download in pdf format:
Extractable and Leachables
Establish Container Closure and Leachable Controls - A Lifecycle Container Closure Database
P. Noland, L. Rosik, L. Schrier, J. Troxell and T. Wilson
Lifecycle Management of Leachable Compounds in an Inhalation Product Using an Extractables Database
P. Noland, L. Rosik, L. Schrier, J. Troxell and T. Wilson
Management of Leachable Compounds throughout the Lifecycle of an Inhalation Product by Utilizing Statistical Experimental Designs and a Component Product Database
P. Noland
Assessing Extractables and Leachables from Coated Bromo-Butyl Rubber Stoppers
K. Davis, L. Lucas and S. Savage
Determination of Extractable and Leachable Formaldehyde in Hydroxypropyl Methylcellulose Capsules by Derivatization and Gas Chromatography-Mass Spectrometry
A. Sen, K. Wells, S. Veeraraghavan, L. Rosik, C. Schouten, J. Troxell and P. Noland
DMPK and Bioanalytical
Validation of a Sensitive ICP-MS Analytical Technique for the Quantitation of Platinum in Human Plasma and Ultrafiltrate
A. LaPaglia, P. Lee, N. CdeBaca, H.Li, Ph.D. and A. Mize, Ph.D.
A Sensitive HPLC-MS/MS Method for the Determination of Apomorphine in Human Plasma
S. Vengurlekar, S. Logue, J. Heitkamp, D. Giltrap and P. Velagaleti
Development and Validation of an Inductively Coupled Mass Spectrometric Method for the Quantitation of Platinum from Oxaliplatin
A. LaPaglia, P. Lee, N. CdeBaca, H. Li and A. Mize, Ph.D.
Validation of an Inductively Coupled Plasma-Atomic Emission Spectrometry (ICP-AES) Assay Method for the Determination of Total Cisplatin and Carboplatin in Human Plasma
F. McCush, B. Hurshman, S. Vengurlekar, P. Velagaleti
A Simultaneous HPLC-MS/MS Method for the Determination of Cortisol and 6β-Hydroxycortisol in Human Urine
F. McCush, M. Haines, J. Heitkamp, S. Vengurlekar and P. Velagaleti
A Simultaneous LC-MS/MS Method for the Determination of Dextromethorphan and Three of its Metabolites in Human Urine
P. Tata, S. Vengurlekar, S. Logue, J. Heitkamp, D. Giltrap and P. Velagaleti
An HPLC-MS/MS Assay Method for the Determination of Alprazolam, Midazolam, α-Hydroxyalprazolam and α-Hydroxymidazolam in Human Plasma
F. McCush, D. Giltrap, M. Reasoner, J. Heitkamp and P. Velagaleti
An HPLC-MS/MS Assay Method for the Determination of Kigoxin in Human Plasma and Urine
J. Malone, L. McWhirter, J. Pollock, P. Dillon, D. Clements and B. Bradley
An HPLC-MS/MS Assay Method for the Determination of Erythromycin in Human Plasma
A. Mize, Ph.D., S. McComish and N. Premkumar, Ph.D.
An HPLC-MS/MS Assay Method for the Determination of Oxycodone and Two of its Metabolites, Noroxycodone and Oxymorphone inHuman Plasma
J. Malone, D. Clements, P. Dillon, F. McCush, P. Velagaleti, D. Giltrap and J. Heitkamp
An HPLC-MS/MS Method for the Determination of Oxycodone, Noroxycodone and Oxymorphone in Human Plasma
J. Malone, D. Clements, D. Giltrap, J. Heitkamp, D. Ching, P. Dillon, F. McCush and P. Velagaleti
An HPLC-MS/MS Method for the Determination of Rifabutin in Human Plasma
J. Malone, P. Dillon, L. McWhirter and D. Clements
An LC-MS/MS Method for Monitoring the Activity of Cytochrome P450 Enzymes Using Standard Probe Substrates
S. Pusalkar, F. McCush, B. Lusiak, B. Wang, K. Cole, S. Stewart, N. Premkumar, Ph.D. and P. Velagaleti
An Optimized and Qualified HPLC-MS/MS Assay Method for Monitoring Cytochrome P450 Isozymes (1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1 AND 3A4) Activities in Human Liver Microsomes (HLM)
H. Li, M. Morris, V. Shah, A. Mize, Ph.D. and N. Premkumar, Ph.D.
Development and Validation of pH 9.0 HPLC-Tandem Mass Spectrometric method for the Quantitation of Ajulemic Acid in Human Plasma
A. LaPaglia1, J. Chaber2, B. Becker1, H. Li1 and A. Mize, Ph.D.1
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., Columbia, MO 65202
2Indevus Pharmaceuticals, Inc., Lexington, MA
Drug Transport Across CACO-2 Cell Monolayers: A Comparison of the Biocoat® Intestinal Epithelium Differentiation Environment vs. the Standard 21-Day Culture Method
T. Bilyeu, R. Hoover, J. Heitkamp and P. Velagaleti
Inter-Species Comparison of In Vitro Plasma Protein Binding of [14C]Warfarin Using Ultrafiltration
P. Velagaleti, J. Lio, J. Durham, K. Cole and N. Premkumar, Ph.D.
Transport Across CACO-2 Cell Monolayers of a Mixture of Beta-Adrenergic Receptor Anatagonists
T. Bilyeu, R. Hoover, O. Nemirovskiy and P. Velagaleti
Validation of an HPLC-MS/MS Assay Method for the Determination of Buprenorphine and Norbuprenorphine in Beagle Plasma
F. McCush, S. Logue, T. Hancock, J. Heitkamp, M. Raub and P. Velagaleti
[14C]Apomorphine: Enterohepatic Recirculation in Rats
K. Cole1, N. Premkumar1, Ph.D., P. Velagaleti1, B. Ronsen2, M. Kukulka3 and B. Bopp3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., Columbia, MO 65202
2Pentech Pharmaceuticals, Inc.
3TAP Holdings, Inc.
A Radioimmunoassay Method for the Quantitation of Octreotide in Male Rat Plasma
P. Velagaleti1, F. McCush1, S. Logue1, M. Miller1, T. Hancock1 and S. Chasteigner2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Cellpep SA, 18, Rue Vignon, 75009 Paris, France
An HPLC-MS/MS Assay Method for the Determination of Budesonide in Human Plasma
F. McCush1, S. Backes1, B. Hurshman1, H. Maddox1, C. Harris1, J. Heitkamp1, M. Raub1, P. Velagaleti1 and D. Beussink2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Sheffield Pharmaceuticals, Inc., 14528 South Outer Forty Road, Suite 205, St. Louis, MO 63017
An HPLC-MS/MS Method for the Determination of Picolinic Acid in Human Plasma
P. Velagaleti1, C. Sheldon1, F. McCush1, H. Maddox1, J. Heitkamp1, M. Raub1 and M. Douglas2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Novactyl Inc., 1816 Lackland Hill Parkway, Suite 220, St. Louis, MO 63146
An HPLC-MS/MS Method for the Determination of PL-2299 in Human, Rat and Beagle Plasma
F. McCush1, H. Maddox1, M. Hartsock1, D. Giltrap1, J. Heitkamp1, P. Velagaleti1, A. Shadiack2 and M. De2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Palatin Technologies, Inc., 4-C Cedar Brook Dr., Cedar Brook Corporate Center, Cranbury, NJ 08512
An HPLC-UV Assay Method for the Determination of 2,3-Dihydroxybenzoic Acid (DHBA) in Rat, Dog and Human Plasma
P. Velagaleti1, C. Sheldon1, T. Hancock1, S. Orr1, F. McCush1, D. Eiznhamer2 and Z. Xu2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2MediChem Research, 2501 Davey Road, Woodridge, IL 60517
An HPLC-UV Assay method for the Determination of Nolatrexed Dihydrochloride in Human Plasma
P. Velagaleti1, C. Sheldon1, T. Hancock1, S. Orr1, F. McCush1, N. Goldman1, C. Byrne2, B. Spencer2 and F. Oldham2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Zrix Inc., 1235 Westlakes Dr., Suite 200 Berwyn, PA 19312
Characterization of CYP450 Isoenzymes Involved in the In Vitro Metabolism of Brinzolamide by Human Liver Microsomes
R. Hoover1, T. Bilyeu1, C. Van't Land2, M. Sanders2, K. Cole1 and P. Velagaleti1
1Analytical Bio-Chemistry (ABC ) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Alcon Research Ltd., Fort Worth, TX
Chiral Separation and LC/MS/MS Quantitation of (R) and (S) Enoximone Sulfoxide Enantiomers in Plasma
L. Eichmeier1, H. Li1, H. Wu1, C. Hartman2, J. Stewart2 and A. Mize, Ph.D.1
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Myogen, Inc., Westminster, CO
Comparison of LC-MS/MS and RIA Assay Methods for the Determination of Octreotide in Rat Plasma
S. McComish1, H. Wu1, N. Premkumar Ph.D.1, J. Downing2, E. Li2, E. Dadey2 and A. Mize, Ph.D.1
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Atrix Laboratories, Fort Collins, CO
Comparison of the Metabolism of J867 Following Intravenous or Oral Administration to Male and Female Bile Duct-Cannulated Rats and Mice
E. Morris1, K. Beltey1, N. Premkumar, Ph.D. 1, P. Velagaleti1, B. Bopp1, N. Castagnoli2, R. Lee3 and D. Mulford3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Virginia Tech University, Blacksburg, VA
3TAP Pharmaceutical Products, Inc., Lake Forest, IL
Determination of Gadoversetamide in Human Plasma by LC-MS/MS and by ICP-AES
R. Hoover1, R. Ramanathan1, R. Gurley1, F. McCush1, P. Velagaleti1 and J. Baker2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Mallinckrodt Medical, Inc., St. Louis, MO 63134
Determination of Gadoversetamide in Human Urine by LC-MS/MS and by ICP-AES
R. Hoover1, R. Ramanathan1, R. Gurley1, F. McCush1, P. Velagaleti1 and J. Baker2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Mallinckrodt Medical, Inc., St. Louis, MO 63134
Disposition and Metabolism of Apomorphine Following Subcutaneous Administration in a Bile Duct-Cannulated Beagle Dog
N. Premkumar, Ph.D.1, P. Velagaleti1, R. Ramanathan1, B. Ronsen2, M. Kukulka3 and B. Bopp3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Pentech Pharmaceuticals, Inc.
3TAP Holdings, Inc.
Drug-Drug Interaction Potential of Enoximone: Inhibition of its Metabolism by Concomitant Clinical Medications
P. Srivastava1, M. Meives1, C. Gliser1, A. Mize, Ph.D.1, N. Premkumar, Ph.D.1 and C. Hartman2
1Analytical Bio-Chemistry Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Myogen, Inc., Westminster, CO
Excretion and Metabolism of [14C]Apomorphine in Healthy Male Subjects
S. Vengurlekar1, O. Nemirovskiy1, P. Velagaleti1, M. Kukulka2, B. Bopp2 and B. Ronsen3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2TAP Holdings, Inc.
3Pentech Pharmaceuticals
HPLC-MS/MS Assay Method for the Determination of PT-141 in Human and Rat Plasma
P. Velagaleti1, C. Sheldon1, H. Maddox1, S. Orr1, F. McCush1, A. Shadiack2 and M. De2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Palatin Technologies, Inc., 175 May St., Suite 500, Edison, NJ 08837
In Vitro Metabolism of Apomorphine by Human, Dog and Rat Hepatocytes
R. Hoover1, M. Kukulka3, T. Bilyeu1, O. Nemirovski1, K. Cole1, P. Velagaleti1, B. Ronsen3 and B. Bopp2
1Analytical Bio-Chemistry Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2TAP Holdings, Inc.
3Pentech Pharmaceuticals, Inc.
Interspecies Comparison of Absorption and Excretion of J867 Following Intravenous or Oral Administration to Mice, Rats and Monkeys
J. Liu1, N. Premkumar, Ph.D.1, P. Velagaleti1, R. Lee2 and D. Mulford2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2TAP Pharmaceutical Products, Inc., Lake Forest, IL
Interspecies Comparison of the Mass Balance and Excretion of Apomorphine Following Subcutaneous Administration in Rats, Mice and Dogs
N. Premkumar, Ph.D.1, P. Velagaleti1, B. Ronsen2, M. Kukulka3 and B. Bopp3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Pentech Pharmaceuticals, Inc.
3TAP Holdings, Inc.
Interspecies comparison: In Vitro Metabolism of J867 by Hepatocytes and Microsomes fro Male and Female Human and Various Animal Species
E. Morris1, T. Bilyeu1, K. Cole1, N. Premkumar, Ph.D.1, P. Velagaleti1, B. Bopp1, N. Castagnoli2, R. Lee3 and D. Mulford3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Virginia Tech University, Blacksburg, VA
3TAP Pharmaceutical Products, Inc., Lake Forest, IL
LC-MS/MS - A Powerful Tool for Identification of metabolites of Apomorphine: In Vivo and In Vitro Studies
O. Nemirovskiy1, R. Hoover1, N. Premkumar, Ph.D.1, P. Velagaleti1, S. Vengurlekar1, B. Ronsen2, M. Kukulka3 and B. Bopp3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Pentech Pharmaceuticals, Inc.
3TAP Holdings, Inc.
Plasma Protein Binding and Whole Blood Distribution of Apomorphine in Plasma and Blood from human, Dog, Rat and Mouse
R. Hoover1, M. Kukulka2, K. Cole1, P. Velagaleti1, B. Ronsen3 and B. Bopp2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2TAP Holdings, Inc.
3Pentech Pharmaceuticals, Inc.
Profiling and Identification of Metabolites of Apomorphine Following Subcutaneous Administration in Rats and Mice
N. Premkumar, Ph.D.1, P. Velagaleti1, O. Nemirovskiy1, R. Ramanathan1, B. Ronsen2, M. Kukulka3 and B. Bopp3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Pentech Pharmaceuticals, Inc.
3TAP Holdings, Inc.
Simultaneous LC-MS/MS Determination of Aripiprazole (OPC-14597) and its Five major Metabolites in Human Urine
J. Heitkamp1, P. Tata2, S. Vengurlekar1, Y. Li1, P. Velagaleti1 and S. Bamer2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Otsuka America Pharmaceutical, Inc., Rockville, MD 20850
Simultaneous LC-MS/MS Determination of Cilostazol (OPC-13013) and Three of its Principal Metabolites in human Plasma
J. Heitkamp1, P. Tata2, S. Vengurlekar1, Y. Li1, P. Velagaleti1 and S. Bramer2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Otsuka America Pharmaceutical, Inc., Rockville, MD 20850
The Absence of an Epoxide Intermediate in the Formation of a Glutathionyl Conjugate of J867
E. Morris1, J. Heitkamp1, W. Tang1, M. Zhou1, N. Premkumar, Ph.D.1, P. Velagaleti1, N. Castagnoli2, R. Lee3 and B. Bopp1
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Virginia Tech University, Blacksburg, VA
3TAP Pharmaceutical Products, Inc., Lake Forest, IL
Tissue Distribution of Radioactivity Following Subcutaneous Dosing of [14C]Apomorphine in Rats and Mice
N. Premkumar, Ph.D.1, P. Velagaleti1, B. Ronsen2, M. Kukulka3 and B. Bopp3
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Pentech Pharmaceuticals, Inc.
3TAP Holdings, Inc.
Validation of an HPLC Assay Method for the Determination of Amlexanox in Human Serum
S. McComish1, A. Mize, Ph.D.1, C. Harris1, N. Premkumar, Ph.D.1 and L.E. Colon2
1Analytical Bio-Chemistry (ABC) Laboratories, Inc., 7200 E. ABC Lane, Columbia, MO 65202
2Access Pharmaceuticals Inc., Dallas, TX
Synthesis
Preparation of N,N'-bis[1R,2R]-2-aminocyclohexyl[-1,2-diaminoethane [ethylene-14C]
J. Shi, Ph.D., V. Blazis, M. Han, A. Yermolenka and E. Tjaden, Ph.D.
Synthesis of [14C]-2,6-Pyridinedicarboxaldehyde
M. Han, E. Tjaden, Ph.D., V. Blazis and S. Roberts
Synthesis of [14C]-4-Nitro-Imidazole
D. Lee and j. Shi, Ph.D.
Synthesis of [14C]-Ethyl 2-Mercaptoacetate
D. Lee and J. Shi, Ph.D.
Synthesis of 2-Acetoxy-Benzoic Acid (Phenyl-U-14C)
Z. Zhong, J. Wolf and J. Shi, Ph.D.
Synthesis of Diethyl Oxalate (1-Keto-14C)
J. Wolf and J. Shi, Ph.D.
The Synthesis of L-Cyclogexylglycine-[ring-d11] and L-Cyclohexylglycine-[1-14C]
D. Jian, Ph.D., T. Carson, J. Shi, Ph.D., P. Kirchhoefer, W. Grandestaff and S. Yalaoui
An Efficient Synthesis of Methyl 2-Methoxy-4-Amino-5-Chloro-Benzoate-(Carbonyl-14C)
D. Jian, Ph.D., P. Kirchhoefer, J. Shi, Ph.D., W. Grandestaff and J. Troxell
Quality Assurance
Metric Based Quality Improvement Program
J. Nabors, J. Dutton, A. Mize, Ph.D. and J. Bucksath
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Several more white papers will posted soon.