Analytic requirements for immunosuppressive drugs in clinical trials

Leslie M. Shaw, Thomas M. Annesley, Bruce Kaplan, Kenneth L. Brayman

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Essential to the evaluation of (1) the pharmacokinetics, (2) concentration-effect relationships, and (3) the application of therapeutic drug monitoring, during new immunosuppressive drug clinical trials, is the development of validated analytical methodology for the measurement of pharmacologically active drug and metabolites in biofluids and tissues. The characteristics of analytical methodology developed for cyclosporines A and G, FK-506, mycophenolate mofetil, and rapamycin during clinical trials will be described. The advantages of establishing validated analytical methodology as early as possible during clinical trials include: (a) early identification of metabolites and their quantitative and pharmacological significance; (b) early development of interpretable PK and PK-PD data; (c) accrual of experience that will be directly useful in patient monitoring after drug approval; (d) optimization of analysis conditions; and (e) early development of reference methodology for therapeutic drug monitoring tests. A suggested set of performance criteria for drug analysis during clinical trials and thereafter will be presented.

Original languageEnglish (US)
Pages (from-to)577-583
Number of pages7
JournalTherapeutic Drug Monitoring
Volume17
Issue number6
StatePublished - 1995
Externally publishedYes

Fingerprint

Immunosuppressive Agents
Clinical Trials
Drug Monitoring
Pharmaceutical Preparations
Metabolites
Mycophenolic Acid
Drug Approval
Physiologic Monitoring
Tacrolimus
Sirolimus
Cyclosporine
Patient monitoring
Pharmacokinetics
Monitoring
Pharmacology
Tissue

Keywords

  • Cyclosporin A
  • Cyclosporin G
  • Mycophenolic acid
  • Sirolimus

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology
  • Toxicology
  • Health, Toxicology and Mutagenesis
  • Biochemistry
  • Biochemistry, Genetics and Molecular Biology(all)
  • Public Health, Environmental and Occupational Health

Cite this

Shaw, L. M., Annesley, T. M., Kaplan, B., & Brayman, K. L. (1995). Analytic requirements for immunosuppressive drugs in clinical trials. Therapeutic Drug Monitoring, 17(6), 577-583.

Analytic requirements for immunosuppressive drugs in clinical trials. / Shaw, Leslie M.; Annesley, Thomas M.; Kaplan, Bruce; Brayman, Kenneth L.

In: Therapeutic Drug Monitoring, Vol. 17, No. 6, 1995, p. 577-583.

Research output: Contribution to journalArticle

Shaw, LM, Annesley, TM, Kaplan, B & Brayman, KL 1995, 'Analytic requirements for immunosuppressive drugs in clinical trials', Therapeutic Drug Monitoring, vol. 17, no. 6, pp. 577-583.
Shaw LM, Annesley TM, Kaplan B, Brayman KL. Analytic requirements for immunosuppressive drugs in clinical trials. Therapeutic Drug Monitoring. 1995;17(6):577-583.
Shaw, Leslie M. ; Annesley, Thomas M. ; Kaplan, Bruce ; Brayman, Kenneth L. / Analytic requirements for immunosuppressive drugs in clinical trials. In: Therapeutic Drug Monitoring. 1995 ; Vol. 17, No. 6. pp. 577-583.
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