Evidence map›Paper›PMID 27650190›Full record

ReviewThe AAPS journal2016

Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

Min Li, Sanna Sander, John Duan, Susan Rosencrance, Sarah Pope Miksinski, Lawrence Yu, Paul Seo, Bhagwant Rege

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

8 authors.

Min LiDivision of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Sanna SanderDivision of Modified Release Products, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
John DuanDivision of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Susan RosencranceOffice of Lifecycle Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Sarah Pope MiksinskiOffice of New Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Lawrence YuOffice of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Paul SeoDivision of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA.
Bhagwant RegeDivision of Modified Release Products, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Food and Drug Administration, Silver Spring, MD, USA. bhagwant.rege@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

Indexed as

Quality ControlAdministration, OralAnimalsBiopharmaceuticsChemistry, PharmaceuticalDelayed-Action PreparationsDrug DiscoveryHumansSolubilityDelayed-Action PreparationsBiopharmaceuticsClinically relevant specificationsControl strategyModified releaseProduct and process understanding

Identifiers

PMID27650190

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.