Dose Selection in Preclinical Studies: Cross-Species Dose Conversion
نویسندگان
چکیده
منابع مشابه
Preclinical Studies of 68Ga-DOTATOC: Biodistribution Assessment in Syrian Rats and Evaluation of Absorbed Dose in Human Organs
Objective(s): Gallium-68 DOTA-DPhe1-Tyr3-Octreotide (68Ga-DOTATOC) has been applied by several European centers for the treatment of a variety of human malignancies. Nevertheless, definitive dosimetric data are yet unavailable. According to the Society of Nuclear Medicine and Molecular Imaging, researchers are investigating the safety and efficacy of this radiotracer to meet Food and Drug Admin...
متن کاملModel selection versus model averaging in dose finding studies.
A key objective of Phase II dose finding studies in clinical drug development is to adequately characterize the dose response relationship of a new drug. An important decision is then on the choice of a suitable dose response function to support dose selection for the subsequent Phase III studies. In this paper, we compare different approaches for model selection and model averaging using mathe...
متن کاملDose selection in stereotactic radiosurgery.
Selecting optimal doses for radiosurgery requires a thorough consideration of existing dose-response data for radiation injury of brain and surrounding structures and of the doseresponse for the desired endpoint (tumor control, obliteration of a vascular malformation, relief of trigeminal neuralgia, etc.). This paper reviews the radiobiological and physics principles that should be considered i...
متن کاملpreclinical studies of 68ga-dotatoc: biodistribution assessment in syrian rats and evaluation of absorbed dose in human organs
objective(s): gallium-68 dota-dphe1-tyr3-octreotide (68ga-dotatoc) has been applied by several european centers for the treatment of a variety of human malignancies. nevertheless, definitive dosimetric data are yet unavailable. according to the society of nuclear medicine and molecular imaging, researchers are investigating the safety and efficacy of this radiotracer to meet food and drug admin...
متن کاملUsing SAS to Assess Dose Proportionality in Dose Escalation Studies
Dose escalation studies provide a good opportunity to assess the linearity of PK parameters. This paper describes hypothesis testing and confidence interval (C.I.) methods for assessing dose proportionality based on linear regression and weighted least squares (WLS) linear regression. SAS® code is presented using an example study and AUCinf data.
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products
سال: 2020
ISSN: 2619-1172,1991-2919
DOI: 10.30895/1991-2919-2020-10-1-19-28