#1
January 31st, 2017, 03:28 PM
| |||
| |||
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
| |||
| |||
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 |
|