Suchergebnisse - "Shah, Rashmi R"

PubPharm (8)

1

ICH E14 Q&A(R2) document : commentary on the further updated recommendations on thorough QT studies

enthalten in: British journal of clinical pharmacology | 2015

von Shah, R. | Morganroth, J. | Kleiman, R.

2

ICH E14 Q & A (R1) document : perspectives on the updated recommendations on thorough QT studies

enthalten in: British journal of clinical pharmacology | 2013

von Shah, R. | Morganroth, J.

3

Early investigation of QTc liability : the role of multiple ascending dose (MAD) study

enthalten in: Drug safety | 2012

von Shah, R. | Morganroth, J.

4

If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?

enthalten in: Pharmacology & therapeutics | 2008

von Shah, R.

5

Cardiac repolarisation and drug regulation : assessing cardiac safety 10 years after the CPMP guidance

enthalten in: Drug safety | 2007

von Shah, R.

6

Drugs, QT interval prolongation and ICH E14 : the need to get it right

enthalten in: Drug safety | 2005

von Shah, R.

7

Drugs, QTc interval prolongation and final ICH E14 guideline : an important milestone with challenges ahead

enthalten in: Drug safety | 2005

von Shah, R.

8

Drug-induced prolongation of the QT interval : regulatory dilemmas and implications for approval and labelling of a new chemical entity

enthalten in: Fundamental & clinical pharmacology | 2002

von Shah, R.

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