scholarly journals Exposure-response analysis after subcutaneous administration of RBP-7000, a once-a-month long-acting Atrigel formulation of risperidone

2017 ◽  
Vol 83 (7) ◽  
pp. 1476-1498 ◽  
Author(s):  
Vijay Ivaturi ◽  
Mathangi Gopalakrishnan ◽  
Jogarao V. S. Gobburu ◽  
Weiyan Zhang ◽  
Yongzhen Liu ◽  
...  
Keyword(s):  
Subcutaneous Administration ◽  
Response Analysis ◽  
Exposure Response ◽  
Long Acting

Off‐label use of Letrozole in Chinese Short Pubertal Boys: Effectiveness, Safety, and Exposure‐Response Analysis

2021 ◽  
Author(s):  
Yuan Xu ◽  
Yan‐Hong Zhang ◽  
Qiu‐Ping Zhang ◽  
Qian‐Qian Zhao ◽  
Xiao‐Fu Cao ◽  
...  
Keyword(s):  
Response Analysis ◽  
Off Label Use ◽  
Off Label ◽  
Exposure Response ◽  
Pubertal Boys ◽  
Label Use

Effective Therapy of Insulinoma by Using Long-Acting Somatostatin Analogue. A Case Report and Literature Review

2011 ◽  
Vol 120 (02) ◽  
pp. 68-72 ◽  
Author(s):  
A. Jawiarczyk ◽  
M. Bolanowski ◽  
J. Syrycka ◽  
G. Bednarek-Tupikowska ◽  
M. Kałużny ◽  
...  
Keyword(s):  
Adrenal Gland ◽  
Somatostatin Receptors ◽  
Subcutaneous Administration ◽  
Pancreatic Neuroendocrine Tumor ◽  
Somatostatin Analogue ◽  
Left Adrenal Gland ◽  
Glucose Levels ◽  
Long Acting ◽  
The Right

AbstractWe are reporting a case of 68-year-old woman with insulinoma, after a non-successful tumor surgery and a long-term diazoxide treatment. She had a lot of hypoglycemia cases, and a weight gain of 50 kg. An abdominal CT scan demonstrated a tumor 28 mm in the diameter, in the head of the pancreas. The patient did not agree for the repeated insulinoma surgery. Furthermore, we found a lesion in the left adrenal gland (14 mm in the diameter) and in the right lung (8 mm in the diameter). Pheochromocytoma was diagnosed on the basis of hypertension, elevated levels of normetanephrine in the 24-h urine collection, and an elevated level of norepinephrine in a plasma sample. After the left adrenal gland removal we observed lower blood pressure. Since we had revealed the presence of somatostatin receptors by the somatostatin receptors scintigraphy, we decided to control hypoglycemia by a monthly subcutaneous administration of the long-acting lanreotide. Because of higher glucose levels (300–400 mg/dl) we started an intense insulin therapy. Nowadays, the patient feels better, she has lost 20 kg of her body weight, and we have observed normal blood glucose levels during the long-term lanreotide treatment. We have noticed neither side effects nor hypoglycemic episodes and we have reduced the dose of insulin. The presented case can be an evidence of the effective treatment of the pancreatic neuroendocrine tumor of insulinoma type, with somatostatin analogue.

scholarly journals Exposure–Response Analysis of Alvocidib (Flavopiridol) Treatment by Bolus or Hybrid Administration in Newly Diagnosed or Relapsed/Refractory Acute Leukemia Patients

2017 ◽  
Vol 23 (14) ◽  
pp. 3592-3600 ◽  
Author(s):  
Carl LaCerte ◽  
Vijay Ivaturi ◽  
Joga Gobburu ◽  
Jacqueline M. Greer ◽  
L. Austin Doyle ◽  
...  
Keyword(s):  
Acute Leukemia ◽  
Response Analysis ◽  
Newly Diagnosed ◽  
Exposure Response

A SCREENING TEST FOR LONG-ACTING CORTICOTROPHIN PREPARATIONS

1964 ◽  
Vol 46 (2) ◽  
pp. 279-284 ◽  
Author(s):  
Claus Rerup ◽  
Pavo Hedner
Keyword(s):  
Screening Test ◽  
Subcutaneous Administration ◽  
High Plasma ◽  
Systemic Effect ◽  
Usual Type ◽  
End Point ◽  
Long Acting

ABSTRACT The mouse assay for corticotrophin, using plasma steroid levels as the response, is shown to be suitable with slight modifications as a screening test for long-acting corticotrophin. Four hours after the subcutaneous administration of 10–20 milliunits of corticotrophin in saline, the plasma steroid levels had virtually returned to the preinjection levels, whereas corticotrophin injections in combination with 15 per cent gelatine or 1 per cent polyphloretin phosphate, resulted in sustained high plasma steroid levels. Unlike the usual type of prolongation (e. g. insulin, testosterone) which is characterized by delayed maximal end-point readings, peak responses were observed at the same time following prolonged or non-prolonged corticotrophin. Significantly higher responses were observed following long-acting preparations at this time (one hour after the injection). The test also enables the investigator to distinguish between a local and systemic effect of the prolonging material. Thus it was shown that polyphloretin phosphate and gelatine were active only when given in local combination with corticotrophin. The advantages of the method together with its limitations for the assessment of a long-acting effect in man are briefly discussed.

P63.02 Exposure-Response Analysis of Lurbinectedin Alone or With Doxorubicin in Overall Survival in Small Cell Lung Cancer

2021 ◽  
Vol 16 (10) ◽  
pp. S1182-S1183
Author(s):  
S. Fudio ◽  
L. Pérez-Ramos ◽  
Q. Wang ◽  
J.A. Lopez-Vilariño ◽  
C. Kahatt ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Response Analysis ◽  
Small Cell Lung ◽  
Exposure Response

scholarly journals Use of Model-Informed Drug Development to Streamline Development of Long-Acting Products: Can These Successes Be Translated to Long-Acting Hormonal Contraceptives?

2021 ◽  
Vol 61 (1) ◽  
pp. 745-756 ◽  
Author(s):  
Li Li ◽  
Doanh Tran ◽  
Hao Zhu ◽  
Praveen Balimane ◽  
Gerald Willett ◽  
...  
Keyword(s):  
Hormonal Contraceptives ◽  
Development Programs ◽  
Contraceptive Methods ◽  
Case Examples ◽  
Unintended Pregnancies ◽  
Exposure Response ◽  
The Us ◽  
Long Acting ◽  
Long Acting Contraceptives ◽  
Conceptual Translation

Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients’ access to these contraceptives may translate into fewer unintended pregnancies and lead to substantial individual and public health benefits. However, development of long-acting products can be complex and challenging. This review provides ( a) an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, ( b) several case examples on how modeling and simulation have been used to streamline the development of long-acting products, and ( c) examples of challenges andopportunities in developing long-acting contraceptives and information on how exposure-response relationships of commonly used progestins may enable regulators and developers to rely on prior findings of effectiveness and safety from an approved contraceptive to streamline the development of long-acting contraceptives. The US Food and Drug Administration is seeking assistance from stakeholders to provide data from studies in which pharmacokinetic and pharmacodynamic or clinical outcomes of hormonal contraceptives were evaluated and not previously submitted.

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