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Therapeutic Innovation & Regulatory Science|September 18, 2018
Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on RosiglitazoneJude Nwokike, Lassane Kabore, Andy StergachisTherapeutic Innovation & Regulatory Science|September 18, 2018
Implementing a Process to Review Product-Specific Misinformation in Online Drug Information CompendiaSonia R Talwar, Nancy T Crudele, Erica H Dankiewicz, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal OsteoporosisNeal E Storm, Frances J RichmondTherapeutic Innovation & Regulatory Science|September 18, 2018
Breakthrough Therapy Designation: Bringing Innovation Swiftly to PatientsArpita ShahTherapeutic Innovation & Regulatory Science|September 18, 2018
A Method of Addressing Proprietary Name Similarity for US Prescription DrugsMelissa D Stockbridge, Kellie TaylorTherapeutic Innovation & Regulatory Science|September 18, 2018
Comparison of Approved Dosages for Pediatric and Adult Populations Based on US Labeling InformationKeizo Hanada, Masayuki Kaneko, Mamoru NarukawaTherapeutic Innovation & Regulatory Science|September 18, 2018
Assessment of the e-Answers Initiative, a New Model for Response by Email to Scientific Information Requests Carried Out by the Medical Information Service of Novartis Pharmaceuticals in Spain: Results of an Internal Satisfaction SurveyClara Amat, Anastasia Sarycheva, Cristina Rodellas, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Sample Size and the Precision of the Confidence Interval in Meta-analysesXiaofeng Steven LiuTherapeutic Innovation & Regulatory Science|September 18, 2018
Incorporating Historical Data in Bayesian Phase I Trial Design: The Caucasian-to-Asian Toxicity Tolerability ProblemKentaro Takeda, Satoshi MoritaTherapeutic Innovation & Regulatory Science|September 18, 2018
The Wider Use of Fixed-Dose Combinations Emphasizes the Need for a Global Approach to Regulatory Guideline DevelopmentYvonne Gautam, Ole J Bjerrum, Merete SchmiegelowPageof 165