THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - CLINICAL DOCUMENT -CLINICAL SUMMARY TABLES

Table 1.1. Summary of Bioavailability Studies

Table 1.2. Summary of In vitro Dissolution Studies

Table 2.1 Summary of Drug-Drug Interaction PK Studies

Table 3.1 Description of Clinical Efficacy and Safety Studies

Table 3.2 Results of Efficacy Studies

Similar tables can be generated for median, for modal, and for maximum dose, or for dose of longest exposure. The same table can be generated for any

pool of studies and any subgroup of interest, e.g., on the basis of age groupings, sex, ethnic factors, comorbid conditions, concomitant medications, or any

combination of these factors.

Dose can also be expressed as mg/kg, mg/m2, or in terms of plasma concentration if such data are available.

D. TABULAR LISTING OF ALL CLINICAL STUDIES

A tabular listing of all clinical studies and related information should be provided. For each

study, this tabular listing should generally include the type of information identified in Table

1 of this guideline. Other information can be included in this table if the applicant considers

it useful. The sequence in which the studies are listed should follow the sequence described

in E: Clinical Study Reports