My Published Articles for ViewsHound: Chemistry, Manufacturing and Controls for New Drug Applications

Wednesday, March 15, 2017

Chemistry, Manufacturing and Controls for New Drug Applications

My primary function as the Chemistry Reviewer and Team Leader in the Division of Anti-Infective Drug Products ( New Drugs Chemistry), when I was still working for FDA was to insure that all chemistry, manufacturing and control(CMC) requirements are followed by the Pharmaceutical companies before their new drug application are approved for marketing.

I had worked for FDA for 12 years. It was of my most satisfying and productive job in my more than 22 years of professional career here in the United States. Working for FDA was the best move I have ever made in my career. My 12 years in the FDA was filled with awards, accomplishments and personal growth. Our life in the suburb of Washington, DC was filled with civic involvements, social and cultural activities, humanitarian projects and pleasant memories. The highlight of our stay in the Washington, D.C area was a private tour of the WHITE HOUSE.

A couple of years ago, I posted this article in my blogs. However, recently I hired a new gardener. He was very friendly and asked me what I was doing before my retirement. I told him to visit my site. I am not sure if my gardener is computer savvy, but he is young and appeared to be curious and intelligent. I hope he reads this:

http://chateaudumer.blogspot.com/2013/12/chemistry-manufacturing-and-controlscmc.html

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Guest Article from Susan Creamer Joy

In The Silence, by Susan Creamer Joy.

Today's guest article is from Susan Creamer Joy. Susan is one of my favorite authors in the ViewsHound community. Susan writes, draws, paints and cobbles together art from found objects making a variety of creations from jewelry to religious shrines. She frequently sports burns on her fingers from her soldering iron, paint on her palms and ink under her fingernails, but her hair is usually combed. When she is not losing time in the creative vortex of her studio, she is likely to be putting her knowledge of metaphysics and esoteric principles including Tarot, numerology, astrology and graphology to good use in consultations. Her children are grown, her husband still works and her four dogs believe she needs serious help. The title of her article is "A Matter Of Love And Death". Thank you Susan.

By the time they reached my bedroom door, I was already sitting up – my stomach ratcheted in the tense grip of an unnamed anxiety; my pillow, unburdened of my drowsy head.

To this day I cannot explain how I heard them coming up those stairs in their bare feet or how I knew that my father struggled to hold his composure as my mother unnaturally clutched at the folds of her dressing gown and followed him through the dark just a little too closely.

As the wooden groan of those old stairs tore into my bones that morning like a hacksaw, all I could see between the predawn shadows was the letter I’d written just hours earlier to my boyfriend, Chris, propped against the lamp on my desk across the room awaiting an envelope.

I had not slept well. It was late November and there had been so many changes since the middle of August when he left for the Air Force in Texas to begin basic training and I began my third new school in as many years.

The conspiracy between fate and the last surge of the Vietnam draft had broken apart the every-waking-minutes of our two-year union with unceremonious indifference. All that night my sleep had been infested by difficult dreams and by the illogical fear that truth and reality were merging into a darkness only a martyr could grasp; and at sixteen, martyrdom seemed reasonable only for the nuns among the poor in Bangladesh

I tried to remind myself that he would be home on leave for Thanksgiving in another few days. It was the only tether to calm I could find, but reviewing the facts offered little relief from my baseless fears.

Chris had been girding his pacifist sensibilities preparing to fight in an unpopular war that had not yet slaughtered its last innocent. I was hovering just over the line of inclusion at an exclusive girl’s school – missing him – and finding myself at odds with these young women and their attachment to propriety and with the prep-school veneer that blinded them to the fact that they were no better than anyone else.

Neither one of us was coping well with the worlds into which we were respectively summoned, and although we both knew that the best hope for any future together depended upon our individual successes apart, it was far from comforting most days.

But in spite of our discomfort, we each did our best; and, of course, there were the letters: Thin, plain-paper sheets with row after row after row of inky blue words penned with the intensity and awkward locutions of a love learned too soon. It had come down to just that little, but without them, I would have had nothing.

Chris was learning to fly. I was learning to drive, and both of us were aching to transport our souls to an earlier time through the hallowed intercourse of memories and dreams. Of course, as with all progress, there was the positive element: We were both clean and drug-free for the first time in years.

Now, without pretense, both healthy cognition and sincere motivation surfaced regularly in my psychology and prompted me to care about myself and to arbitrate against all temptation for a better standing in the world, in school and in my own eyes. I even did my homework.

No longer was I escaping today but, instead, living for my day of escape. Lying still in the dark of my room, I listened to the slow, padded footfall of my parents approaching and looked to the floor and to my history book half hidden beneath the nightstand where I’d tossed it the night before. Even in this early morning dark I could make out the swirls and stars in colored marker and the bubble-formed letters that spelled C H R I S in soft, juvenile curves on the torn book cover I’d fashioned out of a brown paper grocery bag.

I vaguely remembered throwing it there somewhat hastily. I had been doing my homework when a sense of urgency struck and I realized I had not written him as I promised I would and glancing at the clock, I noted it was nine-twenty-three. Why that mattered I had no way of knowing in that strange moment, but within hours, it would be one I would never forget; and although I was becoming drowsy and still needed to finish my work, I felt beyond reason that my letter to him could not wait.

So, I wrote. I would always write. I would always be there. He would always be there.“Suzi."It was my name spoken in the smooth and familiar voice of my mother, although weighted and slow, her head bowed to her chest almost as though she were speaking only to herself.

"Suzi.” She said it again, this time with sharp gravity, like a chisel against stone.

As if on cue, I leaned forward, flanked now by my parents who were sitting on either side of my bed.

I had been waiting for them. I don’t know how. I didn’t know why. The lights in my room remained off, but it seemed that the darkness clung more to them than to me, as though they were holding it there – away from me to give me enough light to see through the next moment. They were crying. My father was crying. My father. “Suzi. We have something very, very bad to tell you." Chris has been in a car accident." And he was killed."

If the world moved forward from that moment, I could not know it. f there were air around me worth breathing, I could not take it in. And if there were another sound beyond the leaden bellow of my own raw grief, I could not hear it.

"Who am I going to talk to? Who am I going to love?” I wailed. Who will love me? In that sodden moment violated by the intrusion of a predawn light that had no business rising, everything I ever believed about happiness, hoped for in life, trusted in or held as my own was annihilated.

After that – there was no after that. After that came months of hollow redundancies that would inform my way of being in the world for years to come. A serial commitment to waking up each morning, remembering he was gone and dedicating the remaining hours to forgetting. To that end I would try anything, drink anything, ingest anything, inject anything. It was a slow and arbitrary suicide by indifference.

Many years later, at 25 years-old and in the midst of a pharmaceutical free-fall leaning dangerously close to terminal, I discovered that I was expecting a child, and after a decade of forgetting, I remembered. I named him Griffin after the legendary winged lion, a symbol of the divine because what he inspired and the miracle that he was, were nothing less. I remembered and I loved again, and I went on to marry and to the gift of two beautiful daughters.

Today my son is struggling not to drown in the same well of drug abuse and apathy that almost swallowed me – his great, divine wings clipped by his own hand; and while it is up to him to restore his place in the sky, I will do my best to help provide an open runway.

In the meantime, I will continue soaring for both of us; bequeathed as I have been, with a determination to fly from a boy whose ragged fate precluded that dream.

Death took one young man from me once upon a dark time. If it has any intention of coming for this one, it will have to go through me. And trust me, it will be in for one hell of a fight.

Note: If you enjoy this article, please let me know.

Wednesday, March 15, 2017

Chemistry, Manufacturing and Controls for New Drug Applications

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