2019
DOI: 10.1038/s41372-019-0469-8
|View full text |Cite
|
Sign up to set email alerts
|

Issues, challenges, and the way forward in conducting clinical trials among neonates: investigators’ perspective

Abstract: Clinical trials are essential to test the safety and efficacy of new treatments in any population. The paucity of drug trials especially in the neonatal population has led to the widespread use of unlicensed or off-label medications, exposing them to the risks of drug toxicity and ineffective treatment. Ethical and operational challenges are no longer considered valid excuses for not conducting drug trials in neonates. We recently participated in a combined phase-2 and phase-3 trial investigating a new indigen… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
1
1
1
1

Citation Types

0
6
0

Year Published

2021
2021
2024
2024

Publication Types

Select...
4
2

Relationship

0
6

Authors

Journals

citations
Cited by 15 publications
(6 citation statements)
references
References 26 publications
0
6
0
Order By: Relevance
“…The newly designed molecules were tested for drug likeliness and pharmacokinetic properties in order to be safe and effective when taken by humans. [54] The molecules were examined for various physicochemical parameters such as molecular weight (MW), number of hydrogen bonds that would be donated by the solute to water molecules in an aqueous solution (Donar HB), number of hydrogen bonds that would be accepted by the solute from water molecules in an aqueous solution (Acceptor HB), octanol/water partition coefficient (logPo/w), aqueous solubility (logPS in mol/L), QPlogHERG, QPCaco, [55] percent of human oral absorption, polar surface area, etc. All the acceptable rages are mentioned in Table 2.…”
Section: Drug-likeness and Admet Prediction Resultsmentioning
confidence: 99%
See 3 more Smart Citations
“…The newly designed molecules were tested for drug likeliness and pharmacokinetic properties in order to be safe and effective when taken by humans. [54] The molecules were examined for various physicochemical parameters such as molecular weight (MW), number of hydrogen bonds that would be donated by the solute to water molecules in an aqueous solution (Donar HB), number of hydrogen bonds that would be accepted by the solute from water molecules in an aqueous solution (Acceptor HB), octanol/water partition coefficient (logPo/w), aqueous solubility (logPS in mol/L), QPlogHERG, QPCaco, [55] percent of human oral absorption, polar surface area, etc. All the acceptable rages are mentioned in Table 2.…”
Section: Drug-likeness and Admet Prediction Resultsmentioning
confidence: 99%
“…We have simulated 6LUD and NME 3 and 6LUD‐S 4 Osimertinib complex for 100 ns to study the stability of the considered complex. This study helps us to understand stability of docked complexes within the protein structure [60] …”
Section: Resultsmentioning
confidence: 99%
See 2 more Smart Citations
“… 12 Despite their high rates of infections, neonates have seldom been identified as a high-priority population for inclusion in clinical research programmes because of the ethical, logistical, regulatory and technical challenges inherent to conducting trials in this age group. 12 , 13 In the context of a sparse global antibiotic development landscape, 8 far fewer trials investigating new antibiotics are currently being conducted in neonates than in adults: six neonatal trials compared with 43 adult trials ( Fig. 2 ).…”
Section: Introductionmentioning
confidence: 99%