Douglas K Spracklin
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Explore the profile of Douglas K Spracklin including associated specialties, affiliations and a list of published articles.
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20
Citations
351
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Recent Articles
1.
James A, Lanshoeft C, Steeno G, Spracklin D, You Z, Sharma R, et al.
Drug Metab Dispos
. 2025 Mar;
53(3):100041.
PMID: 40048992
The mixed matrix method (MmM) is a widely used approach by the pharmaceutical industry for early assessment of whether exposures to major human circulating metabolites, of traditional small-molecule drugs, are...
2.
Cuyckens F, Hvenegaard M, Cassidy K, Spracklin D, James A, Pedersen M, et al.
Drug Metab Dispos
. 2024 Jan;
52(3):153-158.
PMID: 38216306
The administration of radiolabeled drug candidates is considered the gold standard in absorption, distribution, metabolism, and excretion studies for small-molecule drugs since it allows facile and accurate quantification of parent...
3.
Li W, Vazvaei-Smith F, Dear G, Boer J, Cuyckens F, Fraier D, et al.
Clin Pharmacol Ther
. 2023 Dec;
115(5):939-953.
PMID: 38073140
The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development Metabolite Bioanalysis Working Group on the fit-for-purpose metabolite bioanalysis...
4.
Young G, Spracklin D, James A, Hvenegaard M, Pedersen M, Wagner D, et al.
Clin Pharmacol Ther
. 2023 Nov;
115(5):931-938.
PMID: 38018358
A review of the use of microdoses and isotopic microtracers for clinical intravenous pharmacokinetic (i.v. PK) data provision is presented. The extent of application of the varied approaches available and...
5.
Cerny M, Spracklin D, Obach R
Drug Metab Dispos
. 2023 Mar;
51(6):647-656.
PMID: 36973000
Human absorption, distribution, metabolism, and excretion (hADME) studies represent one of the most important clinical studies in terms of obtaining a comprehensive and quantitative overview of the total disposition of...
6.
Young G, Spracklin D, James A, Hvenegaard M, Scarfe G, Wagner D, et al.
Clin Pharmacol Ther
. 2022 Jun;
113(4):775-781.
PMID: 35733280
The human absorption, distribution, metabolism, and excretion (hADME) study is the cornerstone of the clinical pharmacology package for small molecule drugs, providing comprehensive information on the rates and routes of...
7.
Spracklin D, Chen D, Bergman A, Callegari E, Obach R
CPT Pharmacometrics Syst Pharmacol
. 2020 Jun;
9(8):428-434.
PMID: 32562380
The human radiolabeled absorption, distribution, metabolism, and excretion (ADME) study offers a quantitative and comprehensive overall picture of the disposition of a drug, including excretion pattern and metabolite profiles in...
8.
Lall M, Bassyouni A, Bradow J, Brown M, Bundesmann M, Chen J, et al.
J Med Chem
. 2020 May;
63(13):7268-7292.
PMID: 32462865
An experimental approach is described for late-stage lead diversification of frontrunner drug candidates using nanomole-scale amounts of lead compounds for structure-activity relationship development. The process utilizes C-H bond activation methods...
9.
Cerny M, Kalgutkar A, Obach R, Sharma R, Spracklin D, Walker G
J Med Chem
. 2020 Feb;
63(12):6387-6406.
PMID: 32097005
At one time, biotransformation was a descriptive activity in pharmaceutical development, viewed simply as structural elucidation of drug metabolites, completed only once compounds entered clinical development. Herein, we present our...
10.
Schadt S, Bister B, Chowdhury S, Funk C, Hop C, Humphreys W, et al.
Drug Metab Dispos
. 2018 Mar;
46(6):865-878.
PMID: 29487142
Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and...