Evidence map›Paper›PMID 39690373›Full record

ArticleThe AAPS journal2024

Regulatory Considerations for Stability Studies of Co-Processed Active Pharmaceutical Ingredient.

Robert K Orr, Thimma Rawalpally, Lindsey Saunders Gorka, Llorente R Bonaga, Luke Schenck, Stacy Osborne, Deniz Erdemir, Robert J Timpano, Haitao Zhang

Abstract read
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Robert K Orr *Global Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA. robert.orr@merck.com.ORCID 0000-0001-8584-4808
Thimma Rawalpally *Regulatory Affairs, Chemistry, Manufacturing and Controls, AstraZeneca BioPharmaceutical Inc., 1 Medimmune Way, Gaithersburg, MD, 20878, USA. thimma.rawalpally@astrazeneca.com.
Lindsey Saunders Gorka *Global Regulatory Sciences, Chemistry Manufacturing and Controls, Pfizer Inc., Pfizer Research and Development, New York, NY, 10001, USA. lindsey.saunders.gorka@pfizer.com.
Llorente R BonagaGlobal Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA.
Luke SchenckOral Formulation Sciences, Merck & Co., Inc., Rahway, NJ, 07065, USA.
Stacy OsborneGlobal Regulatory Affairs - Chemistry, Manufacturing and Controls, Eli Lilly & Company, Indianapolis, Indiana, 46285, USA.
Deniz ErdemirDrug Product Development, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, New Jersey, 08903, USA.
Robert J TimpanoGlobal Regulatory Sciences, Chemistry Manufacturing and Controls, Pfizer Inc., Pfizer Research and Development, Groton, CT, 06340, USA.
Haitao ZhangChemical Process R&D, Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A co-processed active pharmaceutical ingredient (CP API) is the combination of an active pharmaceutical ingredient (API) with non-active component(s). This technology has been demonstrated to offer numerous benefits, including but not limited to improved API properties and stability. The infrastructure requirements are such that the manufacture of a CP API is typically best suited for an API facility. CP API has been regulated as either an API or as a drug product intermediate (DPI). This variability in the designation has led to ambiguities on the regulatory CMC expectations in the CP API including the stability of CP API and CP API containing products which, in turn has hampered the broader application of this technology in the pharmaceutical industry. This difference in designation also resulted in challenges to the lifecycle management of the regulatory documentation for the CMC information of the CP API.This white paper represents the proposals for the regulatory requirements on stability studies related to CP API and to drug product containing CP API by the CP API Working Group (WG) of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ). Additionally, considerations and the WG's recommendations on the stability studies of CP API from different manufacturing sites or processes and post-approval changes for product containing CP API are described.

Indexed as

Drug StabilityChemistry, PharmaceuticalDrug CompoundingDrug IndustryPharmaceutical PreparationsPharmaceutical PreparationsAmorphous solid dispersionCo-crystalCo-processed active pharmaceutical ingredientRegulatory affairsStability

Identifiers

PMID39690373

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.