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  #1  
January 31st, 2017, 03:28 PM
Unregistered
Guest User
 
Afrezza NDA

Please get the AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, Guide so that I can check it easily?
  #2  
January 31st, 2017, 04:25 PM
Super Moderator
 
Join Date: Mar 2012
Re: Afrezza NDA

As per your concern I will get the AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, Guide so that it would be easy for you to check.

Here are the content which come under file

1 EXECUTIVE SUMMARY

2 TECHNOSPHERE INSULIN INHALATION SYSTEM: DESCRIPTION AND
PROPOSED INDICATIONS

3 BACKGROUND
Product Development Rationale
Disease Background
Diabetes Treatments and Treatment Goals
Obstacles to Effective Glycemic Control
Role of Technosphere Insulin in Diabetes Mellitus Treatment
Regulatory History and Clinical Development Program

4 DRUG PRODUCT
Gen2 Inhaler
Gen2 Inhaler Evaluation
Gen2 Inhaler Development History
Safety Bridging Between the Gen2 and MedTone Inhalers

5 NONCLINICAL DEVELOPMENT

6 CLINICAL PHARMACOLOGY
Overview
Insulin Pharmacokinetics
FDKP Pharmacokinetics
Insulin and FDKP Concentrations in the Lung
Insulin Pharmacodynamics
FDKP Pharmacodynamics
Converting from Subcutaneous Rapid Acting Analogs to Technosphere Insulin
Pharmacokinetic and Pharmacodynamic Conclusions

AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, Guide






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