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FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. To Boehringer’s first and most significant argument, that Congress intended the terms “strength” to match FDA’s interpretation in 2009—prior to the codification of the definition in 21 C.F.R.

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Therapeutic Drug Monitoring (TDM)

RX Note

If the drug level is found to be below or above the range, it will serve as a guide for dosage adjustment. Objectives For simplistic purpose, there are 3 different occasions where we choose to do a TDM: To ensure the narrow therapeutic window drug level is within therapeutic range.

Dosage 52
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Insulin Injections

RX Note

The mean dosage display for NovoPen 4 was >4 times larger than for NovoPen 3. Furthermore, NovoPen 4 offers benefits to diabetic patients with manual or visual improvement. The mean injection force required to operate NovoPen 4 was reduced to 50% compared to NovoPen 3.

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Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

PharmaShots

Company: AstraZeneca First Approval Date: Jul 31, 2009 Generic Name: Saxagliptin Patent Expiration: Jan 2023 2022 Sales: $257M Indication: Type 2 Diabetes Mellitus Onglyza is a member of the dipeptidyl peptidase-4 inhibitor class of oral hypoglycemics used combined with diet and exercise for managing type 2 diabetes.

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Inlet air conveyor optimisation in a continuous tablet coater

European Pharmaceutical Review

Turton, Richard; Challenges in the modeling and prediction of coating of pharmaceutical dosage forms, Powder Technology , 2008, 181, 186–194. References International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Pharmaceutical Development Q8(R2).

Dosage 77
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Computed tomography for in-depth investigation of freeze-dried products

European Pharmaceutical Review

X-ray technology is also increasingly used in pharmaceutical R&D, particularly for examining solid dosage forms, an application for which this technology can be seamlessly adopted. X-ray Microtomography of Solid Dosage Forms. 2009; 38(6): 505–9 [[link] 4. Int J Pharm 2004; 271(1-2): 215–24 [[link] 15129988] 2.

Dosage 80
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Top 20 Radiopharma Companies Based on Market Cap

PharmaShots

Market Cap: $8.57M Founded Year: 2009 Total Employees: ~40 Headquarters: Oslo, Norway Stock Exchange: OSE Nordic Nanovector is a biotech company committed to developing and commercializing antibody-radionuclide conjugates to address significant unmet medical needs. In Aug’21, the US FDA cleared QSam’s IND application for CycloSam.

Dosage 56