Results 251 to 260 of about 5,566,486 (385)

Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information. [PDF]

Med Decis Making
Dijk SW, Krijkamp E, Kunst N, Labrecque JA, Gross CP, Pandit A, Lu CP, Visser LE, Wong JB, Hunink MGM.   +9 more
europepmc   +1 more source

Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications

, 2005
Venkatesh Atul Bhattaram, Brian Booth, Roshni Ramchandani, B. Nhi Beasley, Yaning Wang, Veneeta Tandon, John Duan, Raman Baweja, Patrick Marroum, Ramana Uppoor, Nam Atiqur Rahman, Chandrahas Sahajwalla, J. Robert Powell, Mehul U. Mehta, Jogarao Gobburu   +14 more
openalex   +2 more sources

Regulatory Approval of Cancer Risk-Reducing (Chemopreventive) Drugs: Moving What We Have Learned into the Clinic [PDF]

, 2011
Frank L. Meyskens, Gregory A. Curt, Dean E. Brenner, Gary Gordon, Ronald B. Herberman, Olivera J. Finn, Gary J. Kelloff, Samir N. Khleif, Caroline C. Sigman, Éva Szabó   +9 more
openalex   +1 more source

Current trends in single‐cell RNA sequencing applications in diabetes mellitus

FEBS Open Bio, EarlyView.
Single‐cell RNA sequencing is a powerful approach to decipher the cellular and molecular landscape at a single‐cell resolution. The rapid development of this technology has led to a wide range of applications, including the detection of cellular and molecular mechanisms and the identification and introduction of novel potential diagnostic and ...
Seyed Sajjad Zadian, Khodakaram Jahanbin, Shekoofeh Nikooei, Marzieh Rostaminejad, Arezoo Rahimi, Pedram Abdizadeh, Behnam Alipoor   +6 more
wiley   +1 more source

Surrogate Markers and Drug Approvals [PDF]

Hospital Pharmacy, 2016
openaire   +3 more sources

PHP94 THE ROLE OF HEALTH-RELATED QUALITY OF LIFE DATA IN THE DRUG APPROVAL PROCESSES IN THE UNITED STATES AND EUROPE: A REVIEW OF GUIDANCE DOCUMENTS AND AUTHORIZATIONS OF MEDICINAL PRODUCTS FROM 2006 TO 2010 [PDF]

, 2011
Patrick Marquis, M. Caron, M.P. Emery, Scott K. Jelinek, C. Acquadro   +4 more
openalex   +1 more source

Preparation and characterization of renal cell peptides from fetal rats for their antitumor activity

FEBS Open Bio, EarlyView.
This study aimed to prepare renal cells (RCs) from fetal rats which were digested by enzymes. Candidate peptides RCPs were characterized by capillary HPLC and MS and their bioactivity was predicted using peptideranker. The predicted top 10 bioactive peptides were synthesized.
Zhe Zhang, Yuan Cao, Jing Du, Ying Zhang, Junxia Wang, Ying Yuan, Lianqing Sun   +6 more
wiley   +1 more source

Despite surge in orphan drug designations, approvals still lag [PDF]

, 2011
Monica Heger
openalex   +1 more source

Phenotypic plasticity in a novel set of EGFR tyrosine kinase inhibitor‐adapted non‐small cell lung cancer cell lines

FEBS Open Bio, EarlyView.
Phenotypic plasticity in a newly established set of EGFR inhibitor‐adapted NSCLC cell lines during adaptation and in established cell lines. Here, we introduce novel sublines of the EGFR‐mutant non‐small cell lung cancer (NSCLC) cell lines HCC827 and HCC4006 adapted to the EGFR kinase inhibitors gefitinib (HCC827rGEFI2μm, HCC4006rGEFI1μm), erlotinib ...
Tharsagini V. Nanthaprakash, Campbell W. Gourlay, Ina Oehme, Michelle D. Garrett, Jindrich Cinatl Jr, Mark N. Wass, Martin Michaelis   +6 more
wiley   +1 more source

Class of once-weekly diabetes drugs poised for approval [PDF]

, 2011
Hannah Waters
openalex   +1 more source