19 OpenTox Principles and Best Practices for Trusted Reproducible …
399
Fig. 19.6 Providing data integrity and provenance on the Guardtime blockchain
privacy, access, provenance, integrity, and completeness. We propose to initially
consider the following three cases:
(a) Building and validation of a predictive machine learning model (for property
evaluation purposes, e.g., in the qualification of a characterization method of a
new nanomedicine under consideration for an NDA);
(b) Evaluation of an integrated testing and assessment defined method for evaluating
a safety assessment endpoint, e.g., DILI liability management for an anti-cancer
drug;
(c) Use of processed data from bioassays and personalized omics analysis combined
with other healthcare data supporting stratification and outcome enhancement
in clinical trials (will interact with clinical trial cases).
19.12 Approach to Community Assessment of Best Practice
Developments
We will share our experience within the OpenTox community for developing trusted
reproducible safety assessment solutions including databases, algorithms, modeling,
protocol management, ontology, APIs, Web services, and integrating infrastructure.
Following the philosophy of an open knowledge community and sustainability we
have pioneered within OpenTox, we will make reference solutions, practices, and
guidance created by us available to all the community in open-access mode according
399
Fig. 19.6 Providing data integrity and provenance on the Guardtime blockchain
privacy, access, provenance, integrity, and completeness. We propose to initially
consider the following three cases:
(a) Building and validation of a predictive machine learning model (for property
evaluation purposes, e.g., in the qualification of a characterization method of a
new nanomedicine under consideration for an NDA);
(b) Evaluation of an integrated testing and assessment defined method for evaluating
a safety assessment endpoint, e.g., DILI liability management for an anti-cancer
drug;
(c) Use of processed data from bioassays and personalized omics analysis combined
with other healthcare data supporting stratification and outcome enhancement
in clinical trials (will interact with clinical trial cases).
19.12 Approach to Community Assessment of Best Practice
Developments
We will share our experience within the OpenTox community for developing trusted
reproducible safety assessment solutions including databases, algorithms, modeling,
protocol management, ontology, APIs, Web services, and integrating infrastructure.
Following the philosophy of an open knowledge community and sustainability we
have pioneered within OpenTox, we will make reference solutions, practices, and
guidance created by us available to all the community in open-access mode according