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(Pilot BE Study (Formulations to be Evaluated, Results Analysis, Study…
Pilot BE Study
Formulations to be Evaluated
Results Analysis
Study Design
Root Cause Analysis
Corrective Measures
Bio Discriminative Media Identification
In-Vitro
Evaluation Tools
API
Solubility
Saturation
Kinetic
Intrensic
Biorelevant
API Form
Stability
Inter Conversion
Time of Interconversion
Crystaline:Amorphous
Particle Size
Excipients Quantification
Enabled Formulations
Tg
Solvent Ratio
Process Adopted
Understanding of the System
Type of SD
Impact of Polymers
Impact of ternary Surfactant systems
Dissolutions
Atypical in-vitro evaluations
Granule PSD
Sieve Analysis
Porosity
Wet mass hold time Analysis
Biowaiver
Guidance Available
Guidance not Available
Transport mediated uptake
Eflux ratio > 2
Degradation in GIT
Formulation Strategy
Infringing
Non Infringing
505 b2
Higher Scale ProcessTranslation
Dry Process
Wet Process
Pivotal BE Study
Risk Mitigation
API
Process
Excipients
Bio Discriminative Media
RLD Lot
EB Lot Selection
Study Conduct
Washout Period
Pre-conditioning
Subject Selection [Male/Female]
Study Design
Sample Size
Failed Pivotal BE Study
Justification
Outlier
Food Effect
Metabolite
Criticality of AUC
Repeat Study
Change of RLD Lot
Increase in Sample Size
Change in subject population
Change in study Design
Pre-conditioning if any
Regulatory Query Response
Dissolution F2 not matching
Bio Relevant Media
Bio Complexicity
Critical Parameters for BE