Background. Recently we completed a project and explored the enrichment factors that can be used to increase the ability of the clinical trial to demonstrate the treatment effect. The analyzed data is from a randomized, double blind, placebo-controlled Phase 3 clinical trial conducted in multinational centers. Purposes and Assumptions. Using the analysis data from this […]
Are you planning, or currently in, the process of building your submission clinical data package for a New Drug Application (NDA) or Biologics License Application (BLA)? It can be a complicated process, and in this blog series, we are discussing some of the most important considerations to keep in mind while preparing for FDA submission […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-10-30 16:44:092022-11-04 20:26:50(2 of 4) Transitioning from Clinical Research to FDA Review: Clinical Data Application Assembly Team
The process of developing new pharmaceuticals and biologics is long-drawn, pricey, and heavily regulated. After drug discovery and years of pre-clinical and clinical research, a regulatory authority, such as the U.S. Food and Drug Administration (FDA), must review all animal and human data regarding a product’s safety, efficacy, and biological mechanisms. Successfully achieving market approval […]
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If you are reading this, you are likely in the process of developing a new medication or medical device for FDA approval. Maybe your product is nicely progressing through pre-clinical trials and you’re in the process of building your clinical trial protocols. Maybe you’re evaluating the pharmacology and toxicology data, or maybe you’ve already submitted […]
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Model Implementation with Network Meta-Analysis: We will fit our model using WinBUGS and SAS version 9.4. For the Bayesian implementation we will employ the binomial likelihood for dichotomous outcomes and will use uninformative prior distributions for the treatment effects, and a minimally informative prior distribution for the common heterogeneity SD depending on the outcome. Also, […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-07-22 11:28:222022-11-04 20:29:46(4 of 4) Network Meta-Analysis Series: Model Implementation
Explore Enrichment Factors
in Phase-3 BioBackground. Recently we completed a project and explored the enrichment factors that can be used to increase the ability of the clinical trial to demonstrate the treatment effect. The analyzed data is from a randomized, double blind, placebo-controlled Phase 3 clinical trial conducted in multinational centers. Purposes and Assumptions. Using the analysis data from this […]
(2 of 4) Transitioning from Clinical Research to FDA Review: Clinical Data Application Assembly Team
in FDA Guidelines, Getting FDA ApprovalAre you planning, or currently in, the process of building your submission clinical data package for a New Drug Application (NDA) or Biologics License Application (BLA)? It can be a complicated process, and in this blog series, we are discussing some of the most important considerations to keep in mind while preparing for FDA submission […]
(1 of 4) Transitioning from Clinical Research to FDA Review: Preparing Submission Deliverables
in FDA Guidelines, Getting FDA ApprovalThe process of developing new pharmaceuticals and biologics is long-drawn, pricey, and heavily regulated. After drug discovery and years of pre-clinical and clinical research, a regulatory authority, such as the U.S. Food and Drug Administration (FDA), must review all animal and human data regarding a product’s safety, efficacy, and biological mechanisms. Successfully achieving market approval […]
6 Tips for Communicating with the FDA During Product Development
in Getting FDA ApprovalIf you are reading this, you are likely in the process of developing a new medication or medical device for FDA approval. Maybe your product is nicely progressing through pre-clinical trials and you’re in the process of building your clinical trial protocols. Maybe you’re evaluating the pharmacology and toxicology data, or maybe you’ve already submitted […]
(4 of 4) Network Meta-Analysis Series: Model Implementation
in Network Meta-Analysis SeriesModel Implementation with Network Meta-Analysis: We will fit our model using WinBUGS and SAS version 9.4. For the Bayesian implementation we will employ the binomial likelihood for dichotomous outcomes and will use uninformative prior distributions for the treatment effects, and a minimally informative prior distribution for the common heterogeneity SD depending on the outcome. Also, […]