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TRIPHASE BROCHURE

"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

 

 

 

 

 

Guidance- Post Approval Changes to an NDA

Guidance- Post Approval Changes to NDA Q & A 

Guidance- Post Approval Changes to NDA (Annual Reports) 

Guidance- SUPAC Oral Immediate Release

Guidance- SUPAC Oral Immediate and Modified Release

Guidance- SUPAC Nonsterile Semi-Solids 

Guidance- BACPAC I Drug Substance Intermediates 

Note: Guidances 1 + 2 and BACPAC I govern changes.  FDA states that although BACPAC I (pre-Final Intermediate Changes) has been withdrawn it can be used with Guidance in #1.

 

 

 

 
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