A Activity diagram used in UML 6/9 and SysML B Bachman diagram Booch used in software engineering Block diagram Block Definition Diagram BDD used in SysML C Carroll diagram Cartogram Catalytic cycle Chemical equation Curly arrow diagram Category theory diagrams Cause-and-effect diagram Chord diagram Circuit diagram Class diagram from UML 1/9 Collaboration diagram from UML 2.0 Communication diagram from UML 2.0 Commutative diagram Comparison diagram Component diagram from UML 3/9 Composite structure diagram from UML 2.0 Concept map Constellation diagram Context diagram Control flow diagram Contour diagram Cordier diagram Cross functional flowchart D Data model diagram Data flow diagram Data structure diagram Dendrogram Dependency diagram Deployment diagram from UML 9/9 Dot and cross diagram Double bubble map used in education Drakon-chart E Entity-Relationship diagram ERD Event-driven process chain Euler diagram Eye diagram a diagram of a received telecommunications signal Express-G Extended Functional Flow Block Diagram EFFBD F Family tree Feynman diagram Flow chart Flow process chart Flow diagram Fusion diagram Free body diagram G Gantt chart shows the timing of tasks or activities used in project management Grotrian diagram Goodman diagram shows the fatigue data example: for a wind turbine blades H Hasse diagram HIPO diagram I Internal Block Diagram IBD used in SysML IDEF0 IDEF1 entity relations Interaction overview diagram from UML Ishikawa diagram J Jackson diagram K Karnaugh map Kinematic diagram L Ladder diagram Line of balance Link grammar diagram M Martin ERD Message Sequence Chart Mind map used for learning, brainstorming, memory, visual thinking and problem solving Minkowski spacetime diagram Molecular orbital diagram N N2 Nassi Shneiderman diagram or structogram a representation for structured programming Nomogram Network diagram O Object diagram from UML 2/9 Organigram Onion diagram also known as "stacked Venn diagram" P Package diagram from UML 4/9 and SysML Parametric diagram from SysML PERT Petri net shows the structure of a distributed system as a directed bipartite graph with annotations Phylogenetic tree - represents a phylogeny evolutionary relationships among groups of organisms Piping and instrumentation diagram P&ID Phase diagram used to present solid/liquid/gas information Plant Diagram Pressure volume diagram used to analyse engines Pourbaix diagram Process flow diagram or PFD used in chemical engineering Program structure diagram R Radar chart Radial Diagram Requirement Diagram Used in SysML Rich Picture R-diagram Routing diagram S Sankey diagram represents material, energy or cost flows with quantity proportional arrows in a process network. Sentence diagram represents the grammatical structure of a natural language sentence. Sequence diagram from UML 8/9 and SysML SDL/GR diagram Specification and Description Language. SDL is a formal language used in computer science. Smith chart Spider chart Spray diagram SSADM Structured Systems Analysis and Design Methodology used in software engineering Star chart/Celestial sphere State diagram are used for state machines in software engineering from UML 7/9 Swim lane Syntax diagram used in software engineering to represent a context-free grammar Systems Biology Graphical Notation a graphical notation used in diagrams of biochemical and cellular processes studied in Systems biology System context diagram System structure Systematic layout planning T Timing Diagram: Digital Timing Diagram Timing Diagram: UML 2.0 TQM Diagram Treemap U UML diagram Unified Modeling Language used in software engineering Use case diagram from UML 5/9 and SysML V Value Stream Mapping Venn diagram Voronoi diagram W Warnier-Orr Williot diagram Y Yourdon-Coad see Edward Yourdon, used in software engineering
Development of companion diagnostics (CDx) as powerful tools in precision medicine typically follows one of three pathways: co development, bridging, and follow on. Co development is the most ideal and cost effective CDx pathway: It is conducive to screening target patients specifically and identifying drug targets accurately, reducing development cost and cycle times for pharmaceutical ...
The Current Status for HER2 Testing There is a large portfolio of available human epidermal growth factor receptor 2 (HER2) targeted therapies that have an associated companion diagnostic (CDx) in breast and gastric cancers which confirms ERBB2 amplification status (i.e., HER2 gene amplification) and or HER2 protein overexpression on the surface of tumor cells. These include drugs such as ...
Special Section DIA
Integral to PM are companion diagnostics (CDx), devices designed and developed to select the right patient candidates for the precision drug. Inevitably, this codependent relationship between drug and device flags the need for tight coordination of the development and regulatory review of both products to ensure timely access to PM CDx.
panion diagnostics are a class of diagnostic devices that has become important not only in personalizing therapy for patients, but also for developers of therapeutic products, who must now consider not only development of the drug or biologic, but also development of a diagnostic test to identify or manage patients who use the therapeutic product.
In an era where artificial intelligence (AI) is revolutionizing healthcare and clinical research, regulatory bodies are racing to keep pace.
As these national guidelines and regulations continue to create favorable conditions for development of drug CDx reagents in China, industry has responded with calls for China’s companion diagnostic products regulation to keep pace with drug regulation reform, to learn from advanced regulatory systems like those in Europe and the US, and for ...
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Misalignment on diversity in clinical trials continues. Some sponsors have proactively implemented Diversity Action Plans for their clinical programs ahead of FDA requirements, for example, while other sponsors choose to wait until firm requirements are in place.
Clinical trials generate evidence that ultimately defines the safety and efficacy of a new medical product.
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