Synopsis
Synopsis
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USDMF
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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Listed Suppliers
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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API
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
1. Cytalux
2. Otl-0038
3. Otl-38
4. Otl0038
5. Otl38
1. Otl-38
2. Otl 38
3. Otl 0038
4. Otl38
5. Otl0038
6. Otl-0038
7. Pafolacianine [usan]
8. F7bd3z4x8l
9. 1628423-76-6
10. Unii-f7bd3z4x8l
11. Chembl4297412
12. Who 11569
13. Db15413
Molecular Weight | 1326.5 g/mol |
---|---|
Molecular Formula | C61H67N9O17S4 |
XLogP3 | 4 |
Hydrogen Bond Donor Count | 8 |
Hydrogen Bond Acceptor Count | 22 |
Rotatable Bond Count | 24 |
Exact Mass | 1325.35377640 g/mol |
Monoisotopic Mass | 1325.35377640 g/mol |
Topological Polar Surface Area | 441 Ų |
Heavy Atom Count | 91 |
Formal Charge | 0 |
Complexity | 3330 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 3 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Pafolacianine is an optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
Tumor to background ratios changed with different mass doses studied. High tumor to background ratio was observed with 0.025 mg/kg dose. Pafolacianine exposure-response relationships and the time course of pharmacodynamic responses are unknown.
Molecular Probes
A group of atoms or molecules attached to other molecules or cellular structures and used in studying the properties of these molecules and structures. Radioactive DNA or RNA sequences are used in MOLECULAR GENETICS to detect the presence of a complementary sequence by NUCLEIC ACID HYBRIDIZATION. (See all compounds classified as Molecular Probes.)
Absorption
The mean Cmax of pafolacianine was 59.1 5.94 ng/mL and AUCinf was 63.6 12.6 ng x hr/mL.
Route of Elimination
Following a single intravenous infusion of radiolabeled pafolacianine sodium, approximately 35% of the dose was recovered in urine (19.1%) and in feces (15.8%) after approximately 3-5 weeks.
Volume of Distribution
The mean volume of distribution (Vz) is 17.1 5.99 L, indicating distribution into tissues. During intraoperative molecular imaging for surgically resectable pulmonary adenocarcinoma, pafolacianine accumulated in nearly 70% of squamous cell carcinomas.
Clearance
The mean plasma clearance is 28.6 4.97 L/hr.
The metabolism of pafolacianine is unknown; however, pafolacianine is not metabolized by cytochrome P450 (CYP) enzymes.
The elimination half-life of pafolacianine is 0.44 0.23 hours.
Pafolacianine is consists of folic acid linked by its -carboxyl and a short spacer to an indocyanine green-related near-infrared dye called SO456. It is used for intraoperative fluorescence for tumour identification and surgical resection. It targets the folate receptor alpha (FR), which is often overexpressed in various cancers including ovarian cancer. Pafolacianine binds to FR-expressing cancer cells with an affinity of ~1 nM and is internalized via receptor-mediated endocytosis to be concentrated in FR-positive cancer tissues. Pafolacianine absorbs light and in the near-infrared (NIR) region within a range of 760 nm to 785 nm with a peak absorption of 776 nm and, upon excitation, emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm.
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PharmaCompass offers a list of Pafolacianine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Pafolacianine manufacturer or Pafolacianine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pafolacianine manufacturer or Pafolacianine supplier.
PharmaCompass also assists you with knowing the Pafolacianine API Price utilized in the formulation of products. Pafolacianine API Price is not always fixed or binding as the Pafolacianine Price is obtained through a variety of data sources. The Pafolacianine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pafolacianine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pafolacianine, including repackagers and relabelers. The FDA regulates Pafolacianine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pafolacianine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pafolacianine supplier is an individual or a company that provides Pafolacianine active pharmaceutical ingredient (API) or Pafolacianine finished formulations upon request. The Pafolacianine suppliers may include Pafolacianine API manufacturers, exporters, distributors and traders.
click here to find a list of Pafolacianine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pafolacianine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pafolacianine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Pafolacianine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Pafolacianine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pafolacianine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pafolacianine suppliers with NDC on PharmaCompass.
Pafolacianine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Pafolacianine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pafolacianine GMP manufacturer or Pafolacianine GMP API supplier for your needs.
A Pafolacianine CoA (Certificate of Analysis) is a formal document that attests to Pafolacianine's compliance with Pafolacianine specifications and serves as a tool for batch-level quality control.
Pafolacianine CoA mostly includes findings from lab analyses of a specific batch. For each Pafolacianine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Pafolacianine may be tested according to a variety of international standards, such as European Pharmacopoeia (Pafolacianine EP), Pafolacianine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pafolacianine USP).