Pharmaceutical Regulatory Affairs: Open Access

Title Publication Date Language Citations
Why aren’t biosimilars generics - regulatory challenges2014/01/01
Therapeutic Opportunities through the Modulation of Endocannabinoid Transport2014/01/01
Treatments for Type 2 Diabetes; a Focus on DPP4 Inhibitors2014/01/01
Amide-based Disulfide Building Blocks for the Enlargement of the Solid Phase Peptide Synthesis for Molecular Diagnostics and Imaging2014/01/01
How to Conquer the Inconsistency of D Value Determined by Survivor Curve Method and Fraction Negative Method2014/01/01
Regulation of the Risk of Exposure to Antibiotics in Milk2014/01/01
The Vision of Better Medicines for Children and the Role of Regulatory Authorities2014/01/01
Case Report Form (CRF) Design Made Easy: An Evaluation of Clinical Data Acquisition Standards Harmonization (CDASH) in Use2015/01/01
Compliance to Private Healthcare Facilities and Services Act and Regulations amongst Primary Care Private Clinics in a State in Malaysia2015/01/01
The use of quantitative real-time polymerase chain reaction (qRT-PCR) technologies to screen for the presence of total bacteria in a liquid sample2016/01/01
Risks of inadequate regulatory intelligence2016/01/01
Different Approaches and Timeframes in Anti-Counterfeiting Medicinal Products: Europe vs. United States2016/01/01
Death after Quadrivalent Human Papillomavirus (HPV) Vaccination:Causal or Coincidental?2016/01/01
Capacity Utilization in Pharmaceutical Industry in Nigeria2014/01/01
BSE-Prion2014/01/01
Conotoxins and their Regulatory Considerations2014/01/01
Drug Regulatory Affairs in Quality Management2014/01/01
Recent Developments in Cancer Treatment: A Review2014/01/01
Qualified and Validated Analytical Procedures for Pharmaceutical Products Majoring from Biological Origins2014/01/01
Spontaneous reporting of adverse drug reactions: An effective strategy for post-marketing drug regulation and safety surveillance2014/01/01
Assessment of the antibacterial activity of actinomycetes isolated from terrestrial soil of King Saud University campus2014/01/01
Clinical Trials Regulations in India2012/01/01
Pharmaceutical Regulation: Crossroad of Opportunity as the Distinction between Food and Drugs Blurs2012/01/01
Regulatory requirements and filing considerations for Type II master files2016/01/01
Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System2017/01/01
Effective Processes for Quality Assurance2017/01/01
Stress Testing of Quetiapine Fumarate by a Chemometric Assisted Multi-Component Ion-Interaction System2017/01/01
Evaluation of Insulin Delivery Strategies for Bronson Health Group2017/01/01
Policy Change to Adequately Address Monitoring Conduct in a Risk-Based Environment2017/01/01
Product Life Cycle Management in Regulated Market of Europe2017/01/01