Category 10

Dosing and Administration Methods

8 topics planned. Each topic is published as a Professional and Patient edition only after explicit author approval.

10.1Defining dose
In preparation
1. · Total cells
2. · Cells per kilogram
3. · Viable cells
4. · Particle number
5. · Protein content
6. · Cell-equivalent EV dose
7. · Functional potency
10.2Route of administration
In preparation
1. · Intravenous
2. · Intra-arterial
3. · Intramuscular
4. · Intra-articular
5. · Intrathecal
6. · Intracerebral
7. · Intramyocardial
8. · Intranasal
9. · Inhaled
10. · Topical
11. · Scaffold-based delivery
10.3Local versus systemic delivery
In preparation
1. · Target exposure
2. · Biodistribution
3. · First-pass trapping
4. · Procedure risks
5. · Repeatability
6. · Product loss
10.4Timing
In preparation
1. · Acute injury
2. · Subacute disease
3. · Chronic disease
4. · Inflammatory phase
5. · Repair phase
6. · Relationship to standard treatment
10.5Repeat dosing
In preparation
1. · Biological rationale
2. · Dose intervals
3. · Immune sensitization
4. · Cumulative risk
5. · Durability
6. · Cost
10.6Product preparation
In preparation
1. · Fresh versus frozen
2. · Thawing
3. · Washing
4. · Resuspension
5. · Infusion media
6. · Time from preparation to administration
10.7Administration monitoring
In preparation
1. · Baseline assessment
2. · Vital signs
3. · Infusion reactions
4. · Emergency preparedness
5. · Laboratory monitoring
6. · Postprocedure observation
10.8Dose optimization
In preparation
1. · Dose escalation
2. · Maximum tolerated dose
3. · Minimum effective dose
4. · Biological effective dose
5. · Exposure-response relationships
6. · Personalized dosing claims