Oral medicines in the Paediatric Investigation Plans (n = 150 PIPs); group wise comparison.

*a preparation is a subtype of a dosage form in a particular strength and with a particular excipient composition e.g. a PIP containing film-coated tablets 50 mg and chewable tablets 5, 10 and 20 mg represents one overall dosage form (tablets), two tablet subtype dosage forms (film-coated tablets and chewable tablets) and four preparations (film-coated tablets 50 mg, chewable tablets 5 mg, chewable tablets 10 mg, chewable tablets 20 mg).