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Advice Pool - When You Do Not Know What You Do Not Know
Today I will start right in with the reason I had to write a confession about what I did not know, in the sense that I understood not. It goes way back to a book called Job. In the thirty third chapter I became aware of my plight and quickly repented of my former action that caused my dilemma.
1BE THAT a
1BE THAT a
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
s it may, Job, I beg of you to hear what I have to say and give heed to all my words.
2Behold, here I am with open mouth; here is my tongue talking.
3My words shall express the uprightness of my heart, and my lips shall speak what they know with utter sincerity.
4[It is] the Spirit of God that made me [wh
2Behold, here I am with open mouth; here is my tongue talking.
3My words shall express the uprightness of my heart, and my lips shall speak what they know with utter sincerity.
4[It is] the Spirit of God that made me [wh
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ich has stirred me up], and the breath of the Almighty that gives me life [which inspires me].
5Answer me now, if you can; set your words in order before me; take your stand.
6Behold, I am toward God and before Him even as you are; I also am formed out of the clay [though I speak with abnormal wisdom becau
5Answer me now, if you can; set your words in order before me; take your stand.
6Behold, I am toward God and before Him even as you are; I also am formed out of the clay [though I speak with abnormal wisdom becau
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e of a divine illumination].
7See my terror [for I am only a fellow mortal, not God]; I shall not make you afraid, neither shall my pressure be heavy upon you.
8Surely you have spoken in my hearing, and I have heard the voice of your words, saying,
9I am clean, without transgression; I am innocent, neithe
7See my terror [for I am only a fellow mortal, not God]; I shall not make you afraid, neither shall my pressure be heavy upon you.
8Surely you have spoken in my hearing, and I have heard the voice of your words, saying,
9I am clean, without transgression; I am innocent, neithe
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r is there iniquity in me.
10But behold, God finds occasions against me and causes of alienation and indifference; He counts me as His enemy.
11He puts my feet in the stocks; He [untrustingly] watches all my paths [you say].
12I reply to you, Behold, in this you are not just; God is superior to man.
13Wh
10But behold, God finds occasions against me and causes of alienation and indifference; He counts me as His enemy.
11He puts my feet in the stocks; He [untrustingly] watches all my paths [you say].
12I reply to you, Behold, in this you are not just; God is superior to man.
13Wh
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
do you contend against Him? For He does not give account of any of His actions. [Sufficient for us it should be to know that it is He Who does them.]
14For God [does reveal His will; He] speaks not only once, but more than once, even though men do not regard it [including you, Job].
15[One may hear God's
14For God [does reveal His will; He] speaks not only once, but more than once, even though men do not regard it [including you, Job].
15[One may hear God's
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
voice] in a dream, in a vision of the night, when deep sleep falls on men while slumbering upon the bed,
16Then He opens the ears of men and seals their instruction [terrifying them with warnings],
17That He may withdraw man from his purpose and cut off pride from him [disgusting him with his own disappoin
16Then He opens the ears of men and seals their instruction [terrifying them with warnings],
17That He may withdraw man from his purpose and cut off pride from him [disgusting him with his own disappoin
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ing self-sufficiency].
18He holds him back from the pit [of destruction], and his life from perishing by the sword [of God's destructive judgments].
19[God's voice may be heard by man when] he is chastened with pain upon his bed and with continual strife in his bones or while all his bones are firmly set,
18He holds him back from the pit [of destruction], and his life from perishing by the sword [of God's destructive judgments].
19[God's voice may be heard by man when] he is chastened with pain upon his bed and with continual strife in his bones or while all his bones are firmly set,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
20So that his desire makes him loathe food, and even dainty dishes [nauseate him].
21His flesh is so wasted away that it cannot be seen, and his bones that were not seen stick out.
22Yes, his soul draws near to corruption, and his life to the inflicters of death (the destroyers).
23[God's voice may be he
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
rd] if there is for the hearer a messenger or an angel, an interpreter, one among a thousand, to show to man what is right for him [how to be upright and in right standing with God],
24Then [God] is gracious to him and says, Deliver him from going down into the pit [of destruction]; I have found a ransom (a
24Then [God] is gracious to him and says, Deliver him from going down into the pit [of destruction]; I have found a ransom (a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
price of redemption, an atonement)!
25[Then the man's] flesh shall be restored; it becomes fresher and more tender than a child's; he returns to the days of his youth.
26He prays to God, and He is favorable to him, so that he sees His face with joy; for [God] restores to him his righteousness (his upright
25[Then the man's] flesh shall be restored; it becomes fresher and more tender than a child's; he returns to the days of his youth.
26He prays to God, and He is favorable to him, so that he sees His face with joy; for [God] restores to him his righteousness (his upright
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ness and right standing with God--with its joys).
27He looks upon other men or sings out to them, I have sinned and perverted that which was right, and it did not profit me, or He did not requite me [according to my iniquity]!
28[God] has redeemed my life from going down to the pit [of destruction], and my
27He looks upon other men or sings out to them, I have sinned and perverted that which was right, and it did not profit me, or He did not requite me [according to my iniquity]!
28[God] has redeemed my life from going down to the pit [of destruction], and my
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
life shall see the light!
29[Elihu comments] Behold, God does all these things twice, yes, three times, with a man,
30To bring back his life from the pit [of destruction], that he may be enlightened with the light of the living.
For many years I have seen this bright spot in my mind's eye, as if I am in a
29[Elihu comments] Behold, God does all these things twice, yes, three times, with a man,
30To bring back his life from the pit [of destruction], that he may be enlightened with the light of the living.
For many years I have seen this bright spot in my mind's eye, as if I am in a
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
pit looking up at the sky.And I wonder 'how can this be?'
Apparently pride and judging others can get you thrown into a pit that you dug for them because you think that they are less than you are.
We are what we are by God's choice. Rich or poor, bond or free is His placement. Where and when is up to Him.
We are what we are by God's choice. Rich or poor, bond or free is His placement. Where and when is up to Him.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
Why do we think it has anything to do with us? It is His will, His way, and His plan. Our choices consist of obedience and acceptance or disobedience and rejection of God.
Obedience is by far the greater choice. Acceptance of Him as our savior, Lord, deliverer and healer is a must or the pit awaits-hot and
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
horrible, utter destruction.
I feel as if I have been and am in a pit because of my reluctance and wrong thinking of others. Who am I to judge and who am I to condemn? I am nothing without Jesus Christ and His righteousness.
How can it be that I did not know this sooner, know with understanding and embra
I feel as if I have been and am in a pit because of my reluctance and wrong thinking of others. Who am I to judge and who am I to condemn? I am nothing without Jesus Christ and His righteousness.
How can it be that I did not know this sooner, know with understanding and embra
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e His choice for all?
God help me? God forgive me? god deliver me from this pit I dug for others. Pray for me Jesus. Let Your righteousness be rendered to me because of Your mercy. When will we see and stop digging pits for others? When will we stop judging and stop looking down on anyone?
Idid not know
God help me? God forgive me? god deliver me from this pit I dug for others. Pray for me Jesus. Let Your righteousness be rendered to me because of Your mercy. When will we see and stop digging pits for others? When will we stop judging and stop looking down on anyone?
Idid not know
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
what I did not know.Now I see and say 'You are God, I am not.' End of story.
You make oak trees, asp and ash trees,pine and palm trees.Your choice! You make beavers and buffalo,lizards and tree toads. your Choice!
Not all of Your critters can be together for many and varied reasons. Your choice again Lord.
Not all of Your critters can be together for many and varied reasons. Your choice again Lord.
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
Existing in a pit we have dug for others makes me cry' oh God, hear Jesus for us and deliver us from ourselves and our pits. Change us to know You and Your choices. Make us over fresh and new. Fill us with Your Holy Spirit to hear and obey You. Alert us when we start to think in that wrong direction, Jesus
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
, please. Flash the danger signals. Totally change our thinking. Let mercy, pardon,compassion and understanding become normal for us for Your glory, Your praise, Your adoration.
You lead, guide and direct - Your choice, Yours. Make us what You want us to be to each other for our God reigns in all the earth
You lead, guide and direct - Your choice, Yours. Make us what You want us to be to each other for our God reigns in all the earth
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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