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Table 7 Lot size and amount of materials used in clinical development

From: Superstructure-based process synthesis and economic assessment under uncertainty for solid drug product manufacturing

 PhaseMain/low doseTechnologyLot sizeQuantity
Formulation and process development (formulation)II & IIIMainBatch and continuous1 kg lot−130 lots
Formulation and process development (formulation)II & IIILow (proportional)Batch and continuous0
Formulation and process development (formulation)II & IIILow (common)Batch and continuous1 kg lot−130 lots
Formulation and process development (pre-scale-up)II & IIIMainBatch and continuous5 kg lot−14 lots
Formulation and process development (pre-scale-up)II & IIILow (proportional)Batch and continuous0
Formulation and process development (pre-scale-up)II & IIILow (common)Batch and continuous5 kg lot−14 lots
Scale-up studyIIMainBatch30 kg lot−14 lots
Scale-up studyIILow (proportional)Batch30 kg lot−12 lots
Scale-up studyIILow (common)Batch30 kg lot−14 lots
Scale-up studyIIIMainBatch100 kg lot−14 lots
Scale-up studyIIILow (proportional)Batch100 kg lot−12 lots
Scale-up studyIIILow (common)Batch100 kg lot−14 lots
Scale-up studyII & IIIBothContinuous 
Investigational drug productionIIMainBatch and continuous30 kg lot−12.0 × 105 tabletsa
Investigational drug productionIILow (proportional and common)Batch and continuous30 kg lot−15.0 × 104 tabletsa
Investigational drug productionIIIMainBatch and continuous100 kg lot−18.0 × 105 tabletsa
Investigational drug productionIIILow (proportional and common)Batch and continuous100 kg lot−12.0 × 105 tabletsa
  1. aThe quantity shown in the table is the standard value of the expected required quantity of tablets for clinical trials. In addition, the same amount of placebo is produced for the main and low doses in proportional dosage. For the low dose in common dosage, additional production of placebo is not required because the tablet size is the same as the main dose