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

Formulation and process development (formulation)

II & III

Main

Batch and continuous

1 kg lot⁻¹

30 lots

Formulation and process development (formulation)

II & III

Low (proportional)

Batch and continuous

–

0

Formulation and process development (formulation)

II & III

Low (common)

Batch and continuous

1 kg lot⁻¹

30 lots

Formulation and process development (pre-scale-up)

II & III

Main

Batch and continuous

5 kg lot⁻¹

4 lots

Formulation and process development (pre-scale-up)

II & III

Low (proportional)

Batch and continuous

–

0

Formulation and process development (pre-scale-up)

II & III

Low (common)

Batch and continuous

5 kg lot⁻¹

4 lots

Scale-up study

II

Main

Batch

30 kg lot⁻¹

4 lots

Scale-up study

II

Low (proportional)

Batch

30 kg lot⁻¹

2 lots

Scale-up study

II

Low (common)

Batch

30 kg lot⁻¹

4 lots

Scale-up study

III

Main

Batch

100 kg lot⁻¹

4 lots

Scale-up study

III

Low (proportional)

Batch

100 kg lot⁻¹

2 lots

Scale-up study

III

Low (common)

Batch

100 kg lot⁻¹

4 lots

Scale-up study

II & III

Both

Continuous

–

Investigational drug production

II

Main

Batch and continuous

30 kg lot⁻¹

2.0 × 10⁵ tablets^a

Investigational drug production

II

Low (proportional and common)

Batch and continuous

30 kg lot⁻¹

5.0 × 10⁴ tablets^a

Investigational drug production

III

Main

Batch and continuous

100 kg lot⁻¹

8.0 × 10⁵ tablets^a

Investigational drug production

III

Low (proportional and common)

Batch and continuous

100 kg lot⁻¹

2.0 × 10⁵ tablets^a