相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。Use of the Conditional Marketing Authorization Pathway for Oncology Medicines in Europe
J. Hoekman et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
From Adaptive Licensing to Adaptive Pathways: Delivering a Flexible Life-Span Approach to Bring New Drugs to Patients
H-G Eichler et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2015)
Approvals of drugs with uncertain benefit-risk profiles in Europe
Rita Banzi et al.
EUROPEAN JOURNAL OF INTERNAL MEDICINE (2015)
Risk Management Plans as a Tool for Proactive Pharmacovigilance: A Cohort Study of Newly Approved Drugs in Europe
N. S. Vermeer et al.
CLINICAL PHARMACOLOGY & THERAPEUTICS (2014)
The characteristics and fulfillment of conditional prescription drug approvals in Canada
Michael R. Law
HEALTH POLICY (2014)
FDA's post-approval studies continue to suffer delays and setbacks
Cassandra Willyard
NATURE MEDICINE (2014)
Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration The Class of 2008
Thomas J. Moore et al.
JAMA INTERNAL MEDICINE (2014)
The Food and Drug Administration Amendments Act and Postmarketing Commitments
Kevin Fain et al.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2013)
Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis
Ruben G. Duijnhoven et al.
PLOS MEDICINE (2013)
New horizons in pharmaceutical regulation
Alasdair Breckenridge et al.
NATURE REVIEWS DRUG DISCOVERY (2012)
Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response
Hans-Georg Eichler et al.
NATURE REVIEWS DRUG DISCOVERY (2011)
European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
Kevin V. Blake et al.
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2011)
Evolution of regulatory frameworks
Alasdair Breckenridge et al.
NATURE REVIEWS DRUG DISCOVERY (2010)
Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval
Thijs J. Giezen et al.
DRUG SAFETY (2009)
Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
Hans-Georg Eichler et al.
NATURE REVIEWS DRUG DISCOVERY (2008)