scholarly article | Q13442814 |
P433 | issue | 239 | |
P304 | page(s) | 58942-58960 | |
P577 | publication date | 1992-12-01 | |
P1433 | published in | Federal Register | Q5440362 |
P1476 | title | New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule | |
P478 | volume | 57 |
Q39405736 | 2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil |
Q36891530 | Advancing outcome measures for the new era of drug development in cystic fibrosis |
Q36135251 | Application and impact of population pharmacokinetics in the assessment of antiretroviral pharmacotherapy |
Q35681874 | Application of biomarkers to clinical trials in systemic sclerosis |
Q36284659 | Biomarkers and surrogate endpoints in kidney disease |
Q36045270 | Biomarkers and surrogate markers: an FDA perspective |
Q36439163 | Blood pressure as an example of a biomarker that functions as a surrogate |
Q38623810 | Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. |
Q64256361 | Conditional approval of cancer drugs in Canada: accountability and impact on public funding |
Q38791641 | Current Status of Celiac Disease Drug Development |
Q52911638 | Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization. |
Q24796010 | Losartan and diabetic nephropathy: commentaries on the RENAAL study |
Q34475498 | OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis. |
Q37730520 | Outcomes Assessment in Clinical Trials of Alzheimer's Disease and its Precursors: Readying for Short-term and Long-term Clinical Trial Needs |
Q39534931 | Patient-Reported Outcome Assessments as Endpoints in Studies in Infectious Diseases |
Q37964935 | Role of randomized phase III trials in an era of effective targeted therapies |
Q57065992 | Sobrediagnóstico y sobretratamiento en el ámbito cardiovascular: factores de riesgo, no enfermedades |
Q57173000 | Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials |
Q35792872 | Surrogate end points in pulmonary arterial hypertension: assessing the response to therapy |
Q35058214 | The challenges of conducting clinical endpoint studies |
Q36087521 | Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study |
Q36891520 | Use of lung imaging studies as outcome measures for development of new therapies in cystic fibrosis |