This question was closed without grading. Reason: Answer found elsewhere
Oct 28, 2022 13:21
1 yr ago
23 viewers *
English term
HFD
English to French
Medical
Medical: Pharmaceuticals
In this Adaptive Design study, the decision to proceed to the next dose cohort and the specific dose will be determined by the SRC after review of safety, PK, and available plasma PD1 (target engagement) data from the first 28 days of treatment for all patients in the current cohort to determine whether or not a DLT has been observed, or the toxicokinetic safety limit or the HFD is reached.
Il s'agit du synopsis de l'essai clinique d'un médicament. Je ne parviens pas à comprendre ce que veut dire HFD, c'est le seul exemple de ce sigle dans mon document.
Il s'agit du synopsis de l'essai clinique d'un médicament. Je ne parviens pas à comprendre ce que veut dire HFD, c'est le seul exemple de ce sigle dans mon document.
Reference comments
3 hrs
Reference:
Hand-foot syndrome (HFD)?
Hand-foot syndrome (HFD) is a condition where erythema, scaling, and bullous lesion affect the hand and feet. In this case, a post-nephrectomy renal carcinoma patient prescribed sorafenib developed HFD 1 week after the drug usage. All laboratory parameters were within normal limits. - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071713/
. The drugs implicated in HFD are 5-fluorouracil, capecitabine, cytarabine, pegylated doxorubicin, and tyrosine kinase inhibitors like sunitinib and sorafenib.[2] HFD caused by multikinase inhibitors are distinct from that caused by the traditional chemotherapeutic agents.[3] In this case report, we describe a case of HFD caused by sorafenib. - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071713/
Hand-foot syndrome (HFD) is a condition where erythema, scaling, and bullous lesion affect the hand and feet. In this case, a post-nephrectomy renal carcinoma patient prescribed sorafenib developed HFD 1 week after the drug usage. All laboratory parameters were within normal limits. - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071713/
. The drugs implicated in HFD are 5-fluorouracil, capecitabine, cytarabine, pegylated doxorubicin, and tyrosine kinase inhibitors like sunitinib and sorafenib.[2] HFD caused by multikinase inhibitors are distinct from that caused by the traditional chemotherapeutic agents.[3] In this case report, we describe a case of HFD caused by sorafenib. - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071713/
Peer comments on this reference comment:
| disagree |
liz askew
: How can this possibly make sense when it says "the HFD is reached"???
1 hr
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ok, uma hipótese, seria preciso concordância. It speaks about within normal limits
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| disagree |
Daryo
: it's supposed to make sense for the text being translated// "Context" a dirty word?
1 day 11 hrs
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14 mins
Reference:
Could it be "HED", see
https://www.fda.gov/media/72309/download
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Note added at 15 mins (2022-10-28 13:37:11 GMT)
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The goals of this guidance are to: (1) establish a consistent terminology for discussing the
starting dose; (2) provide common conversion factors for deriving a human equivalent dose
(HED); and (3) delineate a strategy for selecting the MRSD for adult healthy volunteers,
regardless of the projected clinical use. This process is depicted in a flow chart that presents the
decisions and calculations used to generate the MRSD from animal data (see Appendix E
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Note added at 16 mins (2022-10-28 13:38:14 GMT)
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PHASE I/II CLINICAL TRIAL DESIGN AND DOSE FINDING ...
https://med.stanford.edu › dam › cisd › documents
PDF
5 May 2017 — Dose limiting toxicity (DLT). P[toxicity at MTD] = Γ ... If at most one toxicity -> 3 on next higher dose ... HED: Human equivalent dose.
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Note added at 4 hrs (2022-10-28 17:49:29 GMT)
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only other finding =
High fat diet
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Note added at 15 mins (2022-10-28 13:37:11 GMT)
--------------------------------------------------
The goals of this guidance are to: (1) establish a consistent terminology for discussing the
starting dose; (2) provide common conversion factors for deriving a human equivalent dose
(HED); and (3) delineate a strategy for selecting the MRSD for adult healthy volunteers,
regardless of the projected clinical use. This process is depicted in a flow chart that presents the
decisions and calculations used to generate the MRSD from animal data (see Appendix E
--------------------------------------------------
Note added at 16 mins (2022-10-28 13:38:14 GMT)
--------------------------------------------------
PHASE I/II CLINICAL TRIAL DESIGN AND DOSE FINDING ...
https://med.stanford.edu › dam › cisd › documents
5 May 2017 — Dose limiting toxicity (DLT). P[toxicity at MTD] = Γ ... If at most one toxicity -> 3 on next higher dose ... HED: Human equivalent dose.
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Note added at 4 hrs (2022-10-28 17:49:29 GMT)
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only other finding =
High fat diet
Discussion
NDR: the study is about a new drug for solid tumors or lymphoma
Thank you all!
Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT. [ Time Frame: 21 days ]
https://www.clinicaltrials.gov/ct2/show/NCT00900614
The MTD was defined as the highest feasible dose tested in which fewer than 33% of patients experienced DLT attributable to the study drug, when at least six patients were treated at that dose and were assessable for toxicity.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4824307/
Cohorts of 3-6 patients received daily oral therapy and dose limiting toxicities (DLTs) occurring in cycle 1 (28 days) were assessed. Patients are dosed until MTD (defined as ≤1/6 patients with a DLT) or maximum feasible dose (MFD) is reached.
https://aacrjournals.org/cancerres/article/77/4_Supplement/P...