Common Technical Document Sections: IND & BLA/NDA
Regulatory agencies expect nonclinical and clinical data to be presented and summarized in a consistent manner across all sponsors. This applies to the investigational new drug (IND) application in the US as well as the drug approval applications [biologics license application (BLA) and new drug application (NDA) in the US, the marketing authorization approval (MAA) in EU, and Japan new drug application (J-NDA)].
The common technical dossier (CTD) structure presents the information in a consistent manner as developed by the International Committee of Harmonization (ICH). Within this structure, there are assigned locations for bioanalytical reports as well as structured summaries where high level conclusions should be presented.
This training walks the learner through the relevant sections of the CTD from a bioanalytical sciences perspective, providing guidance for both authoring and review sections.
-
Common Technical Document Sections for IND and BLA/NDA
1h 33m
Regulatory agencies expect nonclinical and clinical data to be presented and summarized in a consistent manner across all sponsors. This applies to the investigational new drug (IND) application in the US as well as the drug approval applications [biologics license application (BLA) and new drug ...
-
Common Technical Document Sections: IND & BLA/NDA
1 video
Regulatory agencies expect nonclinical and clinical data to be presented and summarized in a consistent manner across all sponsors. This applies to the investigational new drug (IND) application in the US as well as the drug approval applications [biologics license application (BLA) and new drug ...
-
Developing & Validating Anti-Drug Antibody Assays
1 video
Immune responses in the patient population during clinical trials or post-market are a serious issue facing biologic therapeutics. Regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding a...
-
Developing & Validating Ligand-Binding PK Assays
1 video
Basic concepts in development and validation of assays for pharmacokinetic analysis continue to be a constant presence in an evolving pharmaceutical industry. Even with the advent of new modalities, such as bi-specific antibody drugs and oligonucleotide drugs, the process to develop and validate ...
