FDA deems in vitro data on mutations sufficient to expand cystic fibrosis drug label

被引：10

|

作者：

Ratner, Mark

机构：

来源：

NATURE BIOTECHNOLOGY | 2017年 / 35卷 / 07期

关键词：

D O I：

10.1038/nbt0717-606

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

[No abstract available]

引用

收藏

页码：606 / 607

页数：2

相关论文

共 34 条

[31] Altered intravenous drug disposition in people living with cystic fibrosis: A meta-analysis integrating top-down and bottom-up data
De Sutter, Pieter-Jan
Van Haeverbeke, Maxime
Van Braeckel, Eva
Van Biervliet, Stephanie
Van Bocxlaer, Jan
Vermeulen, An
Gasthuys, Elke
CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY, 2022, 11 (08): : 951 - 966
[32] THE ROLE OF PRO DATA IN THE DRUG APROVAL PROCESS OF PRODUCTS FOR THE TREATMENT OF CYSTIC FIBROSIS IN THE UNITED STATES AND EUROPEA REVIEW OF GUIDANCE DOCUMENTS AND AUTHORIZATIONS OF MEDICINAL PRODUCTS
Acquadro, C.
Castex, M.
Arnould, B.
VALUE IN HEALTH, 2014, 17 (03) : A231 - A231
[33] Prediction of inhibition-based drug-drug interactions using aurscope ADME/DDI® knowledge base from in vitro and in vivo data.: Case study on FDA recommended in vivo probe substrates
Barberan, Olivier
Ijjaali, Ismail
Dubus, Eludie
Petitet, François
Michel, André
DRUG METABOLISM REVIEWS, 2006, 38 : 79 - 80
[34] COMBINING OSCILLATING POSITIVE EXPIRATORY PRESSURE THERAPY WITH INHALATION OF BRONCHODILATOR VIA A BREATH-ACTUATED NEBULIZER AS A NEW TREATMENT MODALITY IN CYSTIC FIBROSIS (CF): IN VITRO DATA TO DETERMINE NEBULIZER PERFORMANCE
Coppolo, D.
Mitchell, J. P.
Schmidt, J.
Meyer, A.
PEDIATRIC PULMONOLOGY, 2013, 48 : 358 - 358

← 1 2 3 4 →