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"If an experiment does not hold out the possibility of causing one to revise one's views, it is hard to see why it should be done at all."

-Peter Medawar
1960 Nobel Laureate

"If you don't have time to do it right, when will you have time to do it over?"

-John Wooden
Basketball Coach

"It's the little details that are vital.  Little things make big things happen."

-John Wooden
Basketball Coach

"Intellectuals solve problems, geniuses prevent them."

-Albert Einstein

"Strive not to be a success, but rather to be of value."

-Albert Einstein

"The whole of science is nothing more than a refinement of everyday thinking."

-Albert Einstein

"Whoever is careless with the truth in small matters can not be trusted with important matters."

-Albert Einstein

"I start where the last man left off."

-Thomas A. Edison

"Hard work doesn't guarantee success, but improves its chances."

-Thomas A. Edison

"Success is dependent on effort"

-Sophocles (496-406)

"Show me a thoroughly satisfied man and I will show you a failure."

-Thomas A. Edison

"The three great essentials to achieve anything are hard work, stick-to-itiveness, and common sense."

-Thomas A. Edison

"What you are will show in what you do."

-Thomas A. Edison

"Opportunity is missed by most people because it is dressed in overalls and looks like work."

-Thomas A. Edison

"When one door closes, another opens; but we often look so long and so regretfully upon the closed door that we do not see the one that has opened for us."

-Alexander Graham Bell

"He who asks a question is a fool for five minutes; he who does not ask a question remains a fool forever."

-Chinese Proverb

"Let me tell you the secret that had led to my goals; my strength lies solely in my tenacity."

-Louis Pasteur

"Nobody is right all the time and even a broken clock is right two times a day."

-Bill Clinton on need to work together to solve problems DNC 2012

"Good science doesn't happen when people are keeping their heads down.  You need a raucous, rowdy discussion"

- Anonymous

"The great tragedy of Science is the slaying of a beautiful hypothesis by an ugly fact."

Thomas H. Huxley, "Biogenesis and Abiogenisis"

"Many consultants can 'turn the crank' but only few know 'when to crank, which crank to turn, which direction to crank, or how many turns."

- Anonymous

"Success is the ability to move from failure to failure with no loss of enthusiasm."

Winston Churchill






Supporting Documents


See also relevant sections in:

Forced Degradation


  • See USP Guideline- Testing small molecules and well characterized biotechnology products



See also following Link



Acceptance Criteria: Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures.

Active moiety: The molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance (21 CFR 314.108(a)). The active moiety is the entire molecule or ion, not the active site.

Detection Limit: The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated as an exact value.

Drug Product: A finished dosage form, for example, a tablet, capsule, or solution that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients (21 CFR 314.3(b)).

Drug Substance/Active Ingredient: An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body. The active ingredient does not include  intermediates used in the synthesis of such ingredient. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect (21 CFR 210.3(b)(7) and 314.3(b)).

Placebo (or Blank): A dosage form that is identical to the drug product except that the drug substance is absent or replaced by an inert ingredient or a mixture of the drug product excipients quantitatively equivalent to those found in the drug product dosage form.

Quantitation Limit: The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample that can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.

Reagent: For analytical procedures, any substance used in a reaction for the purpose of detecting,measuring, examining, or analyzing other substances.

Specification: The quality standards (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved application to confirm the quality of the drug substances, drug products, intermediates, raw materials, reagents, and other components including container closure systems, and in-process materials.

Spiking: The addition of a small known amount of a known compound to a standard, sample, or placebo, typically for the purpose of confirming the performance of an analytical procedure or the

Stability-Indicating Assay: A validated quantitative analytical procedure that can detect the changes with time in the pertinent properties (e.g., active ingredient, preservative level) of the drug substance and drug product. A stability-indicating assay accurately measures the active ingredients without interference from degradation products, process impurities, excipients, or other potential impurities.

Working Standard: A standard that is qualified against and used instead of the reference standard (also known as in-house or secondary standard).





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