BLG 699 Lecture Notes - Lecture 3: Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice

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icici541

31 Aug 2022

School

Ryerson University

Department

Biology

Course

BLG 699

Professor

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Document Summary

There are laws and legislation required for drugs to be developed, tested, trialed, and manufactured in accordance with guidelines so that they are safe and patients" well-being is protected (ng, 2009) Step-by-step procedures and practices that have to be followed. Good laboratory practice (glp): followed if drugs are to be tested on animals. Good clinical practice (gcp): followed if drugs are to be tested on humans. Good manufacturing practice (gmp): followed for the manufacturing of drugs. U. s. food and drug administration (fda) Canada health products and food branch (hpfb) of health canada. Japan ministry of health and labor welfare (mohlw) with pharmaceutical. Agencies and medical device agencies (pmda) as regulatory review. Asia, latin america, central and eastern europe, middle east and africa have independent national regulatory authorities (nras) opportunity markets (om) or. Center of drug evaluations and research (cder) Center of biologics evaluations and research (cber)

Related Questions

Choose the answer that best describes regulatory enzymes.

	a.	Regulatory enzymes are typically composed of multiple subunits.
	b.	Regulatory enzymes often catalyze the first committed reaction of a pathway.
	c.	Regulatory enzymes often display sigmoidal kinetics.
	d.	Regulatory enzymes can be activated and inhibited by allosteric and/or covalent means.
	e.	As opposed to non-regulatory enzymes, will operate at various speeds depending on their regulatory status.
	f.	All of the above are true.

we know that proteins have regulatory functions, and caninteract in many ways. Why postulate regulatory RNA?

ochreclam516

The ara operon (or L-arabinose operon) iscontrolled by a regulator protein encoded by the araC regulatorygene region. This araC regulatory gene synthesizes a regulatoryprotein that is able to exert both a positve and negative controlon the expression of the structural genes of the ara operon. For mydiscussion in class, I need to propose a mechanism or model toeffectively control the expression of the araC gene (and its reg.protein). I am a little hung up on this because the araC gene isalready a regulatory gene. Is it possible that there are additionalregulatory gene/proteins that could upregulate the already presentregulator gene (upstream)? I was also wondering if there is afeedback mechanism involved with regulatory gene/products(proteins) that could play a role in controlling its expression(i.e. positive/ negative feedback inhibition)? If you have anyideas or proposals on how to control the expression of this araCgene (or any regulatory gene for the matter) it would be very muchappreciated! Thank you.

orchidshark425

BLG 699 Lecture Notes - Lecture 3: Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice

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