Recent papers in Clinical Research and Regulatory Affairs

1. Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationshipsClinical Research and Regulatory Affairs · 2016
2. Current regulatory challenges and approaches in the registration of herbal drugs in EuropeClinical Research and Regulatory Affairs · 2016
3. Industry-funded clinical trials: Beneficial or harmful?Clinical Research and Regulatory Affairs · 2015
4. The regulation of fecal microbiota for transplantation: An international perspective for policy and public healthClinical Research and Regulatory Affairs · 2015
5. Inter-ethnic differences in drug response: Implications for drug development and complying with drug regulationClinical Research and Regulatory Affairs · 2015
6. Special population considerations and regulatory affairs for clinical researchClinical Research and Regulatory Affairs · 2015
7. Opportunities to improve clinical trial design in urothelial bladder cancerClinical Research and Regulatory Affairs · 2015
8. Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panelClinical Research and Regulatory Affairs · 2014
9. Adaptive designs for comparative effectiveness research trialsClinical Research and Regulatory Affairs · 2014
10. Bioequivalence studies in Europe before and after 2010Clinical Research and Regulatory Affairs · 2014
11. Comparison of EMA and FDA guidelines for drug interactions: An overviewClinical Research and Regulatory Affairs · 2014
12. Assessment of internet gaming disorder in clinical research: Past and present perspectivesClinical Research and Regulatory Affairs · 2014
13. The pharmacodynamic equivalence of Orlistat 60 mg capsule. An open label, balanced, randomized, multiple-dose, cross-over pharmacodynamic end-point bioequivalence study in healthy, adult, human Asian Indian subjects under fed conditionsClinical Research and Regulatory Affairs · 2013
14. Reducing the average number of patients needed in a phase II trial through novel designClinical Research and Regulatory Affairs · 2013
15. Development and validation of a LC-ESI-MS/MS method for simultaneous quantification of olmesartan and hydrochlothiazide in human K3 EDTA plasma and its application to pharmacokinetic biostudyClinical Research and Regulatory Affairs · 2013
16. Steady state bioequivalence study of dipyridamole ER and acetyl salicylic acid 200 mg + 25  mg capsules in adult healthy male and female volunteers under fasting conditionClinical Research and Regulatory Affairs · 2013
17. Pharmacokinetics of two formulations of alendronate sodium/cholecalciferol (vitamin D3) tablets 70 mg/5600 IU: An open-label, randomized, single-dose, two-treatment, two-period, two-sequence, cross-over, bioequivalence studyClinical Research and Regulatory Affairs · 2013
18. Steady-state pharmacokinetics and bioequivalence study of quetiapine fumarate film-coated tablets 300 mg in adult schizophrenic patientsClinical Research and Regulatory Affairs · 2012
19. Pharmacovigilance regulations in India: A Step forwardClinical Research and Regulatory Affairs · 2012
20. Laboratory information and management system: A tool to increase laboratory productivityClinical Research and Regulatory Affairs · 2012

All papers →