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Article: Pharmacokinetics of rapamycin.

Yatscoff, R W

1996 Volume 28, Issue 2, Page(s) 970–973

Abstract: Based on the present findings, a number of preliminary conclusions can be made regarding the distribution, pharmacokinetics, and therapeutic range investigations with RAPA: (a) the majority of the drug is sequestered in erythrocytes, resulting in whole ... ...

Abstract	Based on the present findings, a number of preliminary conclusions can be made regarding the distribution, pharmacokinetics, and therapeutic range investigations with RAPA: (a) the majority of the drug is sequestered in erythrocytes, resulting in whole blood concentrations; (b) the drug has a relatively long half-life in both humans and animals with 24-hour trough concentrations being within the analytical range of HPLC when immunosuppressive doses are administered; (c) the drug exhibits a proportionality between trough concentrations and dose; (d) trough concentrations of the drug appear to be related to immunosuppressive efficacy and drug-related side effects. The studies described here should provide a basis for the establishment of therapeutic monitoring protocols for RAPA.
MeSH term(s)	Animals ; Clinical Trials as Topic ; Dose-Response Relationship, Drug ; Graft Rejection/prevention & control ; Humans ; Immunosuppressive Agents/blood ; Immunosuppressive Agents/pharmacokinetics ; Immunosuppressive Agents/therapeutic use ; Polyenes/blood ; Polyenes/pharmacokinetics ; Polyenes/therapeutic use ; Sirolimus ; Transplantation Immunology
Chemical Substances	Immunosuppressive Agents ; Polyenes ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	1996-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	82046-5
ISSN	1873-2623 ; 0041-1345
ISSN (online)	1873-2623
ISSN	0041-1345
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Article: Laboratory support for transplantation.

Yatscoff, R W

Clinical chemistry

1994 Volume 40, Issue 11 Pt 2, Page(s) 2166–2173

Abstract: The clinical laboratory plays a major role in support of transplantation. Depending on the spectrum and number of transplants performed, such programs can consume up to 35% of all laboratory testing. This testing can be transplantation-nonspecific or - ... ...

Abstract	The clinical laboratory plays a major role in support of transplantation. Depending on the spectrum and number of transplants performed, such programs can consume up to 35% of all laboratory testing. This testing can be transplantation-nonspecific or -specific. The former constitutes routine laboratory procedures in various areas of laboratory medicine that are common to other categories of patients. Transplantation-specific testing includes tissue typing, procedures for assessment of graft viability/rejection, and measurement of immunosuppressive drugs. Because of the development of new immunosuppressive drugs such as FK506, cyclosporin G, and rapamycin, an increased burden will be placed on laboratories to establish new therapeutic monitoring programs. Preliminary guidelines for monitoring these drugs, similar to those previously established for cyclosporin A, are proposed herein. With the use of an increasing spectrum of immunosuppressive drug combinations, and the possible use of xenotransplantation on the horizon, new demands will be placed on the laboratory for the support of transplant programs.
MeSH term(s)	Chemistry, Clinical ; Drug Monitoring ; Graft Rejection ; Histocompatibility Testing ; Humans ; Immunosuppressive Agents ; Laboratories ; Transplantation
Chemical Substances	Immunosuppressive Agents
Language	English
Publishing date	1994-11
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
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Article: Cyclosporine monitoring: consensus recommendations and guidelines. Canadian Consensus Meeting on Cyclosporine Monitoring.

Yatscoff, R W

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne

1991 Volume 144, Issue 9, Page(s) 1119–1120

MeSH term(s)	Cyclosporins/blood ; Humans ; Monitoring, Physiologic/standards
Chemical Substances	Cyclosporins
Language	English
Publishing date	1991-05-01
Publishing country	Canada
Document type	Guideline ; Journal Article
ZDB-ID	215506-0
ISSN	1488-2329 ; 0820-3946 ; 0008-4409
ISSN (online)	1488-2329
ISSN	0820-3946 ; 0008-4409
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Article: Requirements for therapeutic drug monitoring of sirolimus, an immunosuppressive agent used in renal transplantation.

Aspeslet, L J / Yatscoff, R W

Clinical therapeutics

2000 Volume 22 Suppl B, Page(s) B86–92

Abstract: Background: On September 15, 1999, sirolimus received approval from the US Food and Drug Administration (FDA) for marketing as an immunosuppressive agent. As with any chronically administered medication, the question arises whether therapeutic drug ... ...

Abstract	Background: On September 15, 1999, sirolimus received approval from the US Food and Drug Administration (FDA) for marketing as an immunosuppressive agent. As with any chronically administered medication, the question arises whether therapeutic drug monitoring (TDM) is required for optimal therapy. In the case of sirolimus, there are data to suggest that TDM may be beneficial in some patients. Objective: To assess the need for monitoring sirolimus concentrations, this paper reviews the following factors influencing the usefulness of TDM: wide pharmacokinetic variability; toxicity; suspected noncompliance; suspected drug interactions; and specific demographic characteristics. Data supporting the correlation between sirolimus concentration and immunosuppressive efficacy are also discussed. Results: The available literature on sirolimus suggests that TDM may be required in some cases. Studies have shown that there is wide interindividual variability in the pharmacokinetic behavior of drugs in transplant patients; that there is a relationship between blood concentrations of sirolimus and adverse events; and that coadministration of cyclosporine alters the pharmacokinetics of sirolimus. Additionally, the correlation between sirolimus concentration and immunosuppressive efficacy in phase III trials suggests a benefit in transplant patients when sirolimus concentrations reach appropriate levels. Finally, noncompliance is a common occurrence in the transplant population, and monitoring is often necessary in suspected noncompliers. Conclusion: Although additional clinical studies are needed, it appears that TDM is an important aspect of treatment with sirolimus.
MeSH term(s)	Drug Interactions ; Drug Monitoring ; Humans ; Immunosuppressive Agents/adverse effects ; Immunosuppressive Agents/blood ; Immunosuppressive Agents/pharmacokinetics ; Kidney Transplantation/immunology ; Sirolimus/adverse effects ; Sirolimus/blood ; Sirolimus/pharmacokinetics
Chemical Substances	Immunosuppressive Agents ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	2000
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	603113-4
ISSN	1879-114X ; 0149-2918
ISSN (online)	1879-114X
ISSN	0149-2918
DOI	10.1016/s0149-2918(00)89025-6
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Zs.A 1435: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article: Evaluation of cyclosporine kit utilizing an iodinated tracer and double antibody precipitation.

Yatscoff, R W

Clinical biochemistry

1987 Volume 20, Issue 3, Page(s) 191–195

Abstract: Due to the increasing number of requests for Cyclosporine quantification, less time-consuming methods are being sought. A commercially available radioimmunoassay which utilizes an 125I-Cyclosporine tracer and double antibody precipitation to separate ... ...

Abstract	Due to the increasing number of requests for Cyclosporine quantification, less time-consuming methods are being sought. A commercially available radioimmunoassay which utilizes an 125I-Cyclosporine tracer and double antibody precipitation to separate free and bound fraction is described. The assay was evaluated with standards prepared in-house as well as those supplied by the manufacturer. With both types of standards, the assay exhibited between-run coefficients of variation of less than 14.3%, recoveries near 100% and good parallelism. When the Cyclosporine values obtained with the 125I-RIA calibrated with standards provided in the kit were compared with those obtained with the RIA supplied by Sandoz, a relatively large proportional and constant error was noted. When the comparison was repeated, with the former assay being calibrated with standards prepared in-house, the magnitude of these errors was significantly reduced. With both types of standards the 125I-RIA exhibited good correlation with Cyclosporine values obtained by HPLC. This RIA is suitable for the relatively rapid quantification of Cyclosporine.
MeSH term(s)	Chromatography, High Pressure Liquid ; Cyclosporins/analysis ; Evaluation Studies as Topic ; Humans ; Iodine Radioisotopes ; Precipitin Tests ; Radioimmunoassay ; Reagent Kits, Diagnostic
Chemical Substances	Cyclosporins ; Iodine Radioisotopes ; Reagent Kits, Diagnostic
Language	English
Publishing date	1987-06
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	0009-9120
ISSN	0009-9120
DOI	10.1016/s0009-9120(87)80119-4
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Zs.A 624: Show issues

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Article: The monitoring of immunosuppressive drugs: a pharmacodynamic approach.

Yatscoff, R W / Aspeslet, L J

Therapeutic drug monitoring

1998 Volume 20, Issue 5, Page(s) 459–463

Abstract: Pharmacodynamic monitoring measures biologic response to a drug, which, alone or coupled with pharmacokinetics, provides a novel method for the optimization of drug dosing. Pharmacodynamic monitoring has been investigated by us and other investigators on ...

Abstract	Pharmacodynamic monitoring measures biologic response to a drug, which, alone or coupled with pharmacokinetics, provides a novel method for the optimization of drug dosing. Pharmacodynamic monitoring has been investigated by us and other investigators on primarily five immunosuppressive drugs: cyclosporine (CsA), mycophenolate mofetil (MMF), rapamycin (RAPA), azathioprine (AZA), and methylprednisolone (MP). The pharmacodynamic monitoring of CsA and MMF involves measurement of the activity of the enzymes calcineurin and inosine monophosphate dehydrogenase, respectively. The pharmacodynamics of AZA are assessed by measurement of the activity of thiopurine methyl transferase (TPMT), which is induced by a metabolite of AZA, 6-mercaptopurine. The pharmacodyamics for RAPA involve the measurement of a P70 S6 kinase activity within lymphocytes, whereas that for MP involves the measurement of the endogenous synthesis of cortisol by the suppression of the hypothalamic pituitary axis. To date, the most detailed studies have been performed involving pharmacodynamic monitoring of CsA and MMF. Similarities exist in the pharmacodynamic response to CsA and MMF in patients who undergo renal transplantation. At trough concentrations in blood, both drugs result in only a 50% reduction in activity of their target enzymes; however, there is considerable interpatient variability. Throughout the dosing interval, enzyme activity parallels that of drug concentrations. Renal transplant recipients who are treated with AZA and who exhibit an increase in TPMT activity from the time of transplantation experience fewer episodes of active rejection. Renal transplant recipients who are administered MP and in whom suppression of endogenous synthesis of cortisol is greatest exhibit the least incidence of steroid-induced side effects. Additional clinical trials relating pharmacokinetics and pharmacodynamic parameters to clinical response are under way to ascertain which provides the best guide for dosing. Pharmacodynamic monitoring may provide an alternative approach to traditional drug level measurement.
MeSH term(s)	Azathioprine/pharmacology ; Cyclosporine/pharmacology ; Drug Monitoring/methods ; Humans ; Immunosuppressive Agents/pharmacokinetics ; Immunosuppressive Agents/pharmacology ; Methylprednisolone/pharmacology ; Mycophenolic Acid/analogs & derivatives ; Mycophenolic Acid/pharmacology ; Sirolimus/pharmacology
Chemical Substances	Immunosuppressive Agents ; Cyclosporine (83HN0GTJ6D) ; Mycophenolic Acid (HU9DX48N0T) ; Azathioprine (MRK240IY2L) ; Sirolimus (W36ZG6FT64) ; Methylprednisolone (X4W7ZR7023)
Language	English
Publishing date	1998-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	424443-6
ISSN	1536-3694 ; 0163-4356
ISSN (online)	1536-3694
ISSN	0163-4356
DOI	10.1097/00007691-199810000-00002
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Zs.A 1503: Show issues

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Article: P70 S6 kinase assay: a pharmacodynamic monitoring strategy for rapamycin; assay development.

Gallant, H L / Yatscoff, R W

Transplantation proceedings

1996 Volume 28, Issue 6, Page(s) 3058–3061

MeSH term(s)	Cells, Cultured ; Cyclosporine/pharmacology ; Drug Monitoring/methods ; Humans ; Immunosuppressive Agents/pharmacology ; Kinetics ; Leukocytes/enzymology ; Lymphocytes/enzymology ; Polyenes/pharmacology ; Protein-Serine-Threonine Kinases/metabolism ; Ribosomal Protein S6 Kinases ; Sirolimus ; Time Factors
Chemical Substances	Immunosuppressive Agents ; Polyenes ; Cyclosporine (83HN0GTJ6D) ; Protein-Serine-Threonine Kinases (EC 2.7.11.1) ; Ribosomal Protein S6 Kinases (EC 2.7.11.1) ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	1996-12
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	82046-5
ISSN	1873-2623 ; 0041-1345
ISSN (online)	1873-2623
ISSN	0041-1345
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Article: Improved high-performance liquid chromatographic assay for the measurement of mycophenolic acid in human plasma.

Li, S / Yatscoff, R W

Transplantation proceedings

1996 Volume 28, Issue 2, Page(s) 938–940

MeSH term(s)	Chromatography, High Pressure Liquid/methods ; Chromatography, High Pressure Liquid/standards ; Cyclosporine/therapeutic use ; Humans ; Immunosuppressive Agents/metabolism ; Immunosuppressive Agents/therapeutic use ; Kidney Transplantation/immunology ; Kidney Transplantation/physiology ; Laboratories/standards ; Mycophenolic Acid/analogs & derivatives ; Mycophenolic Acid/blood ; Mycophenolic Acid/isolation & purification ; Mycophenolic Acid/metabolism ; Mycophenolic Acid/therapeutic use ; Prednisone/blood ; Prednisone/isolation & purification ; Prodrugs ; Quality Control ; Regression Analysis ; Reproducibility of Results ; Sensitivity and Specificity ; Transplantation, Homologous
Chemical Substances	Immunosuppressive Agents ; Prodrugs ; Cyclosporine (83HN0GTJ6D) ; Mycophenolic Acid (HU9DX48N0T) ; Prednisone (VB0R961HZT)
Language	English
Publishing date	1996-04
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	82046-5
ISSN	1873-2623 ; 0041-1345
ISSN (online)	1873-2623
ISSN	0041-1345
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Article: An in vitro method for predicting in vivo oral bioavailability of novel immunosuppressive drugs.

Dias, V C / Yatscoff, R W

Clinical biochemistry

1996 Volume 29, Issue 1, Page(s) 43–49

Abstract: Objective: To evaluate an in vitro method for predicting oral availability of novel immunosuppressive drugs, cyclosporine A (CsA) and rapamycin (RAPA).: Methods: In this study, we report the development and characterization of an in vitro method to ... ...

Abstract	Objective: To evaluate an in vitro method for predicting oral availability of novel immunosuppressive drugs, cyclosporine A (CsA) and rapamycin (RAPA). Methods: In this study, we report the development and characterization of an in vitro method to study the influence of vehicle composition on cyclosporine A (CsA) and rapamycin (RAPA) drug efflux across 12 days postconfluent, absorptive human Caco-2 intestinal epithelial cell monolayers. The apical-to-basal (Jab) and the basal-to-apical (Jba) fluxes of 0.5 muCi 3H-CsA or 0.05 muCi 14C-RAPA solubilized in a 10 mg/L final drug concentration in vehicle were measured. Results: The Jab CsA flux was found to be dose dependent, temperature sensitive, and highly polarized (Jab > Jba). For CsA the vehicles were Neoral, Sandimmune, 95% (v/v) ethanol/fetal bovine serum (ethanol/FBS); and for RAPA these were polyethylene glycol/dimethylacetamide (PEG/DMA), polysorbate/Phosal PEG, ethanol/FBS. When Neoral-CsA was tested, the Jab flux of 3H-CsA was the highest and increased almost linearly even after an incubate time of 240 min. The Jab flux of 3H-CsA when Sandimmune-CsA or ethanol/FBS-CsA were used as vehicle was lower and reached a maximal rate by 120 min. In contrast the Jab flux of 14C-RAPA using either PEG/DMA-RAPA or ethanol/FBS-RAPA as vehicle was highest and reached a maximal rate by 120 min, in contrast to the polysorbate/Phosal PEG-RAPA vehicle, which was significantly lower. Conclusion: These data are consistent with the pharmacokinetics of these ISD reported in vivo in human patients or in rabbits, using the same vehicles in the oral formulation. As an integral part of drug development, the data presented that an in vitro system as described may be useful in predicting the effect of drug vehicle on absorption in vivo.
MeSH term(s)	Administration, Oral ; Biological Availability ; Biological Transport ; Caco-2 Cells ; Culture Media ; Cyclosporine/pharmacokinetics ; Humans ; Immunosuppressive Agents/pharmacokinetics ; Intestinal Absorption ; Permeability ; Pharmaceutical Vehicles ; Polyenes/pharmacokinetics ; Sirolimus ; Temperature
Chemical Substances	Culture Media ; Immunosuppressive Agents ; Pharmaceutical Vehicles ; Polyenes ; Cyclosporine (83HN0GTJ6D) ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	1996-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	0009-9120
ISSN	0009-9120
DOI	10.1016/0009-9120(95)02015-2
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Zs.A 624: Show issues

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Article: Effect of rapamycin on morphological and functional parameters in the kidney of the rabbit.

Thliveris, J A / Yatscoff, R W

Transplantation

1995 Volume 59, Issue 3, Page(s) 427–429

MeSH term(s)	Animals ; Blood Pressure/drug effects ; Creatinine/blood ; Glomerular Filtration Rate/drug effects ; Kidney/drug effects ; Kidney/physiopathology ; Polyenes/pharmacology ; Rabbits ; Regional Blood Flow/drug effects ; Sirolimus
Chemical Substances	Polyenes ; Creatinine (AYI8EX34EU) ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	1995-02-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	208424-7
ISSN	1534-6080 ; 0041-1337
ISSN (online)	1534-6080
ISSN	0041-1337
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