Evidence map›Paper›PMID 31482243›Full record

ReviewPharmaceutical research2019

Quality-by-Design Concepts to Improve Nanotechnology-Based Drug Development.

Meghana Rawal, Amit Singh, Mansoor M Amiji

Abstract readReview
PubMed Publisher
In one paragraph

Review in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

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  12. Functionalization ofPharmaceuticals (Basel, Switzerland) · 2024
    Article
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  19. Nanocomplexes of doxorubicin and DNA fragments for efficient and safe cancer chemotherapy.Journal of controlled release : official journal of the Controlled Release Society · 2023
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Meghana RawalAllExcel Inc., 1 Controls Drive, Shelton, Connecticut, 06484, USA. rawal@uw.edu.ORCID http://orcid.org/0000-0002-9656-9300
Amit SinghPureTech Health, 6 Tide Street, Boston, Massachusetts, 02110, USA.
Mansoor M AmijiDepartment of Pharmaceutical Sciences, School of Pharmacy, Bouve College of Health Sciences, Northeastern University, 360 Huntington Avenue, Boston, Massachusetts, 02115, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this review is to discuss the challenges associated with the development of nanoparticle-based quality drug products in adhering to the principles of quality by design (QbD) and defining appropriate quality parameters towards successful product development. With the advent of nanotechnology into the pharmaceutical field, the novel field of nanomedicine was born. Due to their unique properties in terms of size, conformation and targeted delivery, nanomedicines are able to overcome many drawbacks of conventional medicine. As nano-sized formulations have made their way into more and more therapies, it has became clear that these very unique properties create hurdles for nanomedicines in successfully traversing the regulatory pathways and there is a need to develop nanomedicines in a more controlled and consistent fashion. The elements of a QbD methodology explained in this review enable the development of nano-based formulations in a way that maximizes the possibility of success. The identification of critical quality attributes (CQA) of the drug product and its intermediates are discussed in detail with a focus on nanomaterial-based formulations. In conclusion, QbD and the identification and specification of CQAs at its core are critical to the design, development and growth of nanomaterials in pharmaceuticals.

Indexed as

AnimalsDelayed-Action PreparationsDrug CompoundingDrug DevelopmentDrug StabilityHumansHydrophobic and Hydrophilic InteractionsNanocapsulesNanomedicineNanotechnologyTreatment OutcomeDelayed-Action PreparationsNanocapsulescharacterizationcritical process parameters (CPP)critical quality attributes (CQA)quality by design (QbD)quality target product profile (QTPP)

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.