Need of Bioavailability Studies in Paediatric Dosage Form

Hussen, Syed Sajjad and Srikant, TS and Vasantharaju, SG and Gumudavelly, Sandeep (2011) Need of Bioavailability Studies in Paediatric Dosage Form. IJPI’s Journal of Pharmaceutics and Cosmetology, 1 (5). pp. 40-52.

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The bioavailability (BA) studies explains rate of absorption of drug availability in body. Paediatrics has immature organ and body system so paediatric dosage forms have to comply with specific regulation. The paediatric use marketing authorisation (PUMA) helps under article 45& article 46 for the development of expired or going to expire patent medicines for children trials. It also creates support measures to manage the operation of the paediatric regulation including the paediatric committee within the European medicinal agency, US Food and Drugs Administration and other regulatory authorities. The main objectives of this study are to motivate the development of medicines for use in children and ensuring that medicines used to treat children are: 1. Subject to high quality research 2. Appropriately authorised for use in children, 3. Improving the information available on the use of medicines in children Resulting in safety & effectiveness data for children in clinical trial as well as paediatrics dosage form. Achieving the above objectives without subjecting children to unnecessary clinical trials or delaying the authorisation of medicine in paediatrics and changes carried out in labelling as required for paediatrics. The BA studies are done to formulate requirements for their design, conduct, and evaluation for Patient/ volunteer ranges between 0-14 years i.e. under 1 year (Infants) system & organ are not developed & immatured;1-4 years (Toddlers) organs are developing but not matured ;5-9 years (Early Childhood) organs & system are developed ; 10-14 years (Middle Childhood)similar to adult .

Item Type: Article
Uncontrolled Keywords: Bio-availability, Bio-equivalence, Paediatrics & Regulatory concern
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Manipal
Date Deposited: 23 Jan 2012 06:32
Last Modified: 23 Jan 2012 06:32

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