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30 Aug 2016, 7:52 am
Cubist argued that from Lin and Jiang it was not obvious that pH should be controlled to affect the CMC rather than methanol, and that at the priority date varying pH was not recognised as a method to control CMC, only temperature control, varying of the solvent, or adding an inert electrolyte. [read post]
20 Mar 2014, 5:34 pm
Alcon itself admitted that variation in parameters including pH, preservatives, and buffers can have a substantial impact on the chemical stability of a prostaglandin in an ophthalmic formulation. [read post]
10 Jun 2015, 11:51 am by Tom Lamb
Diabetic ketoacidosis (DKA) is a relatively rare medical condition with blood glucose of 250 mg/dL or higher with ketonuria, ketonemia, and metabolic acidosis (pH < 7.3 or blood bicarbonate levels < 15 mEq/L. [read post]
31 Dec 2020, 6:30 am by ernst
PHS Dispensary No. 32 (LC)[Longtime LHB readers will recall that for the exam in my legal history course I write an essay about some administrative regime I did not cover in class and ask students to compare it with ones we did. [read post]
6 Jan 2020, 12:19 am by News Desk
Your firm prepares pH buffer solution from a powder but does not have written instructions for pH buffer solution preparation, storage, or pH meter calibration. [read post]
18 Feb 2015, 8:50 am by James Hoffmann
Acid Burns and Irritants The chemicals that have a lower pH level compared to alkali solutions cause acid burns. [read post]
30 Apr 2015, 4:16 pm by James Yang
During the trial court proceedings of the Cadence case, the court construed the term “buffering agent” broadly to mean “an agent that helps the formulation resist change in pH. [read post]
26 Aug 2010, 2:59 am
 Inspectors took samples of the two products during the inspections and subjected them to tests, which showed they exceeded both pH and water activity safe levels. [read post]
11 Oct 2015, 10:03 pm by News Desk
Following a March 2015 inspection of the facility, inspectors noted inadequate pH monitoring, no production and processing records and no written recall procedure, FDA’s letter stated. [read post]
5 Aug 2011, 2:20 pm by Aaron Barkoff
" With respect to the formulation claims, the district court found that the solution disclosed in Yamamoto is not a "pharmaceutical composition for injection"--i.e., "a composition that is suitable for treating medical conditions by injection"--because to be suitable for injection into human patients a pharmaceutical composition must have a pH above 3, and the Yamamoto solution has a pH between 1.5 and 1.7. [read post]
16 Sep 2010, 2:59 am
 "Specifically, your firm does not monitor or record the finished equilibrium pH of any of the acidified egg products you manufacture to ensure that finished product pH does not exceed 4.6. [read post]
10 Nov 2019, 9:04 pm by News Desk
  We noted that during the inspection that no one at your firm has received training in critical factors in the production of acidified products, pH controls and critical factors in acidification. [read post]
11 Apr 2015, 7:19 am by The Law Office of Philip D. Cave
Under the “old” Article 32, the right to call and examine witnesses and to obtain production (discovery) of evidence was pretty robust. [read post]
8 Aug 2016, 9:37 pm
Source: ADPAN (2 August 2016)https://adpan.org/2016/08/05/adpan-urges-philippines-to-be-strong-and-reject-attempts-to-re-introduce-the-death-penalty/By Paolo Taruc, CNN PhilippinesUpdated 19:30 PM PHT Tue, August 2, 2016Metro Manila (CNN Philippines) — President Rodrigo Duterte and some lawmakers have called for the return of the death penalty as a way to strengthen the rule of law. [read post]
21 Jun 2018, 12:33 pm by Mike Mireles
To restore the careful balance of the Hatch-Waxman Act and the BPCIA, and to prevent the IPR or PGR processes from undercutting them, the FD&C Act and the PHS Act would be amended to prevent using IPR (or PGR) challenges to circumvent the specific patent challenge processes for drugs and biologics painstakingly created by Congress. [read post]