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Specialized inIvacaftorand related product development and production

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Estimated delivery time: 3-5 days

Ivacaftor User Guide: Comprehensive Overview, Applications, Case Studies & Purchasing Information

Table of Contents

1. Product Specifications & Comparative Analysis

Parameter Ivacaftor Lumacaftor/Ivacaftor Tezacaftor/Ivacaftor
Active Ingredients Ivacaftor 150mg Lumacaftor 200mg/Ivacaftor 125mg Tezacaftor 100mg/Ivacaftor 150mg
Indications G551D mutation & other gating mutations F508del homozygous F508del heterozygous
Dosing Frequency Q12H Q12H Q12H
FDA Approval Year 2012 2015 2018

2. Clinical Applications & Therapeutic Use

Ivacaftor demonstrates exceptional efficacy in:

  • Enhancing CFTR protein function in patients with gating mutations
  • Improving pulmonary function (FEV1 increase 10-15%)
  • Reducing pulmonary exacerbations by 55%
  • Normalizing sweat chloride levels within 2 weeks

3. Administration Guidelines & Best Practices

Optimal Administration Protocol:

  1. Take with high-fat food (20-30g fat content)
  2. Maintain consistent dosing schedule (±1 hour)
  3. Monitor liver enzymes bi-monthly initially
  4. Assess CYP3A interactions with concomitant medications

4. Clinical Case Studies & Patient Outcomes

Case Study 1: 24yo male G551D mutation

  • Baseline FEV1: 58% predicted
  • Week 4: FEV1 ↑14.5%
  • Month 6: 62% reduction in IV antibiotics

Case Study 2: Pediatric patient R117H mutation

  • Sweat chloride reduction from 98mmol/L to 42mmol/L
  • BMI percentile improvement from 25th to 48th

5. Enterprise Client Implementations

University Hospital Implementation:

  • 132 CF patients treated since 2019
  • 78% reduction in hospital admissions
  • $2.3M annual cost savings

Regional Healthcare Network:

  • Implemented genetic screening protocol
  • 94% mutation detection rate
  • Treatment initiation within 14 days of diagnosis

6. Consultation & Procurement Services

Contact our therapeutic specialists for:

  • Genetic testing coordination
  • Dosage optimization strategies
  • Insurance prior authorization support
  • Volume purchasing agreements

Email: info@vivalr.com
Phone: (86) 15866781826

Technical Specifications Deep Dive

Ivacaftor's pharmacokinetic profile shows:

  • Tmax: 4 hours post-dose
  • Half-life: 12 hours (±3)
  • Protein binding: 99%

Mutation-Specific Efficacy Data

Mutation Type FEV1 Improvement Sweat Chloride Reduction
G551D 16.7% 48.1mmol/L
R117H 9.3% 34.6mmol/L

Global Clinical Trial Insights

Phase III trials demonstrated:

  • 26-week sustained efficacy
  • 12.5% BMI improvement in pediatric cohort
  • QoL score increase of 8.2 points
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This is William, CEO of fousi chemical Chemical Co., Ltd.

Welcome to visit our factory . As the top chemical manufacturer, we have been striving for product quality, innovation , R&D, and customer service for the past 7 years. In the next 10 years or even longer, we are committed to becoming the most reliable chemical supplier in the world , creating a well-known international brand trusted by customers, with the spirit of “one meter wide, ten thousand meters deep”, we continue to focus on product research and development, continue to focus on customer service, continue to improve the supply chain service system, to create a professional chemical supply service team, to achieve win-win long-term cooperation. Please feel free to contact us if you have any questions.

Drug impurities to intermediates. Years of expertise.

Experience in the synthesis of complex compounds derived from American technology
Focus on the synthesis of difficult compounds
ISO 17034 dual system certification
National high-tech enterprise
5000+ square meters R&D center
A 70+ R&D team led by Chinese and foreign doctors
150 pieces (sets) of R&D equipment, 120+ fume hoods
18 patents

Solid QMS. Offer top-quality products and services.

Through more than ten years of continuous technological innovation and experience accumulation, the team's R&D personnel have established a complete quality management system for CATO, and have successively obtained ISO9001, ISO17034, CNAS and other international certifications.
It has successfully passed on-site inspections from the United States, Australia, Poland, Japan and domestic pharmaceutical company customers and institutions many times, providing high-quality one-stop services for R&D and production of new drugs around the world.

More than 150 sets of equipment to ensure quality.

The emphasis on quality is the basis for our survival and development, and is the most basic requirement for the products and services we provide. CATO has established a scientific, strict and comprehensive quality prevention and assurance system in accordance with international quality standards. Through advanced testing equipment such as GC-MS, chromatograph, nuclear magnetic resonance, scanning electron microscope, and ultraviolet light, quality management is implemented into every aspect of production and operation activities such as raw materials, inventory, production, testing, sales, verification, and training, and "All actions are controlled and traceable" as the work code of conduct for CATO employees.

Over 1000 cases. Synthesize complex compounds.

Currently, CATO serves more than 500 pharmaceutical companies, biotechnology and other companies around the world. Project types cover the entire cycle from pre-clinical to commercialization stages. As of 2020, CATO has delivered more than 1,000 projects in total.
The company has core technologies in key core technology fields such as high-end fluorine chemistry, asymmetric chiral synthesis, glycoside and biological enzyme technology, and continuous microreactors.

About the company

International Standard Chemicals Sell To All Over The World

FAQ

Does it support auditing?

Support, please make an appointment one day in advance. Company address: Room 716, Building 3, Ligao International Garden, No.1222 West Aoti Road, Lixia District, Jinan City, Shandong Province, P.R. China

Whether to provide samples?

Free samples can be provided for low value products, and small packaging specifications can be purchased for high value products.

Delivery time

Under normal circumstances, all items are in stock and will be shipped before 4 o'clock on the same day. Some products are produced to order, depending on the workshop situation and production schedule.

What is the production capacity?

At present, the company's workshop production equipment is mainly based on laboratories and pilot lines, with a maximum daily production capacity of 1.5 tons.

Can additional test indicators be added?

We can provide moisture, UV, IR, HNMR, CNMR, two-dimensional nuclear magnetic spectroscopy, optical rotation detection, elemental analysis, TGA analysis and residue analysis and other related tests to support personalized needs.

Technical direction

In the early stage, our company mainly engaged in drug impurity synthesis and standard product production, with core technologies in chirality, fluorine chemistry, and heterocycles.

Why Chem-iso’s delivery rate is guaranteed to be 99.99%

5000+

square meter R&D center

150+

China(set) of R&D equipment

150+

Fume hood

180+

R&D team

User’evaluation of us

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Michael Cooper

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James Black

" Sincere Chemical team visited our USA factory in the year of 2017. We think highly of cooperation with them. We thanked you for the past excellent orders and best product quality. We also talked about some new products for future orders. We will be still in strategic cooperation in the future and help each other."

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