(The British Forum for the Use of Medicines in Childhood, 1998). It has been said, 'When the USA sneezes, Europe catches a cold.' On 2 December 2000, it became mandatory in the USA that all new drug applications (NDAs) and some biological ones must contain a pediatric component if ...
2012. Pediatric non-clinical drug testing principles, requirements, and practice. Wiley, Hoboken, NJ.Lewis EM, De Schaepdrijver LM, and Coogan TP. Intro- duction. In: Pediatric Non-clinical Drug Testing: Princi- ples, Requirements, and Practices. AM Hoberman, and EM Lewis (eds). John ...
Indeed, crushing tablets can impair the efficacy and safety parameters of the drug by changing the absorption characteristics, the stability, and the palatability [6], [7], [9]. Such manipulation would present potential for medication errors in dose calculation or preparation, lead to an ...
Given the complexity of pediatric cataracts' pathophysiology, which involves genetic mutations, metabolic disturbances, infections, drug effects, trauma, and environmental influences, comprehending these mechanisms is essential for devising effective preventive and therapeutic interventions to preserve vision in ...
Adverse Drug Reaction Monitoring in Pediatric Practice NA Kshirsagar,S Karande 被引量: 0发表: 1997年 Adverse drug reaction monitoring of ciprofloxacin in pediatric practice. Ciprofloxacin, a fluoroquinolone antibacterial agent, is not recommended in pediatric population on account of its possible adverse...
Calculation showed that 9.9% of the total days for the entire sample were considered preventable. This represented a potentially preventable 2-year cost of $580,000 for the 14 diagnostic categories.DOI: 10.1016/S0002-7138(09)60452-0 被引量: 14 ...
Codeine is a drug that remains in world-wide clinical usage despite the availability of other opi-oids that are far better understood in terms of pharmacodynamics, pharmacokinetics, and side effects. Its continuing usage in clinical practice highlights a paradoxical inconsistency in the prescribing habi...
Number of Patients.The precision of PK and E-R parameters in the sample size calculation are critical for neonatal studies. Prior knowledge of the disease, exposure, and response from adult and other relevant pediatric data, such as that related to variability, can be used to derive sample siz...
PTMS, influenced by weight gain and drug-induced hyperlipidemia and diabetes, is a crucial factor associated with the development of de novo NAFLD in liver transplant recipients [144]. Guidelines from the American Association for the Study of Liver Disease and the American Society of Transplantation...
A biosimilar is a drug that is not significantly different from an established FDA approved drug with regards to its structure, pharmacokinetics (PK), pharmacodynamics (PD), purity, mechanism, safety, potency, and immunogenicity. ABP 959, a biosimilar to FDA-licensed Eculizumab, was tested in hea...