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Pediatric drug development

Cappon GD, Bailey GP, Buschmann J et al (2009) Juvenile animal toxicity study designs to support pediatric drug development. Birth Defects Res B Dev Reprod Toxicol 86(6) 463 69... [Pg.340]

FOOD AND DRUG ADMINISTRATION INITIATIVES TO PROMOTE PEDIATRIC DRUG DEVELOPMENT... [Pg.726]

Other Electronic Sources of Information on Regulatory Aspects of Pediatric Drug Development... [Pg.735]

In addition, the International Conference on Harmonization has issued a guidance document pertinent to pediatric drug development Ell, Clinical Investigation of Medicinal Products in the Pediatric Population (www.fda.gov/cder/guidance/index.htm). [Pg.735]

Ontogeny Plays an Important Role in Pediatric Drug Development and Therapy... [Pg.672]

Leeder JS, Kearns GL, Spielberg SP et al (2010) Understanding the relative roles of pharmacogenetics and ontogeny in pediatric drug development and regulatory science. J Clin Pharmacol 50 1377-1387... [Pg.681]

Samant TS, Mangal N, Lukacova V, Schmidt S (2015) Quantitative clinical pharmacology for size and age scaling in pediatric drug development a systematic review. J Clin Pharmacol 55 1207-1217... [Pg.23]

Spielberg SP, Portman R (2015) New horizons in pediatric drug development. Ther Innov Regul Sci 49 613-614... [Pg.23]

Currie GP, Devereux GS, Lee DKC, Ayres JG. Recent developments in asthma management. BMJ 2005 330 585-589. de Benedictis FM, Selvaggio D. Use of inhaler devices in pediatric asthma. Pediatr Drugs 2000 5 629-638. [Pg.230]

The success of the various special-case areas of drug development regulation and performance, such as orphan drugs, cancer, and AIDS drugs, and the pediatric exclusivity extension could be a guide to how to approach - and what to avoid -in creating larger facilitatory approaches in the future. [Pg.634]

Several problems unique to pediatric drug therapy deserve special mention. For example, most medications are commercially available only in adult dose forms. Preparing pediatric doses from adult tablets or capsules can be very difficult and may require special skill on the part of the pharmacist. For some drugs it is simpler to administer the intravenous (IV) preparation orally than to develop a preparation from the oral medication. [Pg.58]

Kayumba, P. C., Huyghebaert, N., Cordelia, C., Ntawukuliryayo, J. D., Vervaet, C., and Remon, J. P. (2007). Quinine sulphate pellets for flexible pediatric drug dosing Formulation development and evaluation of taste-masking efficiency using the electronic tongue. Eur. J. Pharm. Biophurm. 66,460-465. [Pg.113]

See other pages where Pediatric drug development is mentioned: [Pg.361]    [Pg.235]    [Pg.279]    [Pg.361]    [Pg.235]    [Pg.279]    [Pg.277]    [Pg.356]    [Pg.76]    [Pg.182]    [Pg.295]    [Pg.725]    [Pg.726]    [Pg.727]    [Pg.728]    [Pg.731]    [Pg.734]    [Pg.799]    [Pg.117]    [Pg.245]    [Pg.130]    [Pg.12]    [Pg.360]    [Pg.362]    [Pg.519]    [Pg.523]    [Pg.998]    [Pg.310]   


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