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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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From Healing to Harm: The Unintended Consequences of Polypharmacy in Seniors

PharmD Live

Medication Non-Adherence Polypharmacy increases the likelihood of medication non-adherence due to the complexity and confusion of managing multiple medications.Patients often struggle with the regimen, missing doses, taking incorrect dosages, or discontinuing medications altogether, which can lead to suboptimal treatment results.

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Preserving antibiotic efficacy with an advanced coating process to prevent Amoxicillin and Clavulanic Acid tablet degradation

European Pharmaceutical Review

Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice (2nd ed.). Lachman L, Lieberman H A, Kanig J L. The Theory and Practice of Industrial Pharmacy (4th ed.). CBS Publishers & Distributors. Rowe R C, Sheskey P J, Quinn M E. Handbook of Pharmaceutical Excipients (6th ed.). Pharmaceutical Press. Academic Press.

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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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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.

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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).

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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.

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