Summary - Relationships

It took me over a year to make my final decision to end a friendship with a woman I'd socialized with on a weekly basis for more than five years. Perhaps I was afraid that I was being selfish or shortsighted by calling it quits. I worried that it was somehow wrong of me to seriously consider throwing

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

away a friendship that wasn't particularly bad. It just wasn't good enough to continue spending time on.

My ruminating thoughts of uncertainty and the accompanying feelings of guilt persisted. I didn't want to make a big mistake and regret taking what could easily be an irreversible step. I wasn't

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

able to come up with anything legitimate sin my friend had committed. Nevertheless my mind was made up. I knew I'd had my fill of this person. I felt stifled. It was the same old thing week after week, month after month year after year. It was like repeating a school grade over and over again. My dil

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

mma was no longer a question of if but when and how I would say good-bye.

It wasn't as though I hadn't given the easier, softer way a shot. I'd tried the tapering approach for several months. I hoped if slowly untangled myself from our weekly commitment by being busy some of the time, she would grad

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ually adjust to the idea of socializing less frequently. Perhaps I gently push her into a new habit of meeting once or twice a month. But just when I thought she was adjusting to the idea, she'd rev up her efforts to get us back on track to meet weekly.

I suffered some anticipatory nostalgia at the

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

the thought of walking away. Close friends don't grow on trees, at least not in my world. This woman and I had walked and talked our way through divorces, new relationships, subsequent break-ups and reconciliations. We'd shared a variety triumphs, defeats and struggles with our children. We had sons

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

nd daughters that were close in age. The two of us had also been equally guilty spending plenty of time of analyzing and judging the lives of our mutual "recovery" acquaintances.

"I don't trust him. We're friends."
Bertolt Brecht

While there had been some give and take over the years, we esse

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

ntially had a therapist/patient dynamic going much of the time with me playing the role of the counselor. I never got terribly upset about the imbalance because I was aware my basic personality type was in large part to blame. I typically ask a lot of questions and tend to steer the conversation away

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

from sharing my deepest feelings. So it was natural then for me to gravitate toward someone who likes to talk about themselves and asked little about my life.

Don't walk in front of me, I might not follow. Don't walk behind me, I might not lead. Walk beside me and be my friend.
Author Unknown

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

Despite our differences in personality, I often reassured myself that the two of us shared a solid and deepening .I believed I'd found a lifelong friend and the only thing that would ever change is that we'd grow closer. So I was surprised and confused when I noticed that I was looking less and less

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

forward to our regularly scheduled outings. I wondered what my problem was.

Although I was craving to make an exit, a little voice inside kept questioning my sanity. She's was, after all, one of the few friends I have on earth. She's a hospice nurse for god's sake. What if someday I am on my death

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

bed ravaged by some unspeakably painful illness and no one else is around. Will I be sorry then? Will I be kicking myself with what little energy my fragile body has left then for so carelessly tossing her out of my life?

My last straw came (and I admit I was probably looking for one) when she calle

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

on a Tuesday to book our Saturday. She wanted to make sure we were scheduled before I made other plans. When I listened to that message I knew my tiptoeing away approach was a total failure. I'd had enough.

I decided to sleep on what my next move would be but I knew I had to take action. I was not

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

willing to blow her off completely and I didn't want the stress of telling her the truth.

I chose a medium path and one she'd advocated for her in situations when she didn't want to deal with a person directly. I would mail her a card! What a brilliant idea.

The next day I found a "Thinking of You"

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

card. I felt that would be appropriate and honest because I was thinking of her. The card was blank inside and I filled up the page explaining that while I always consider her a friend, I needed a break and I wasn't up to meeting on a regular basis. I left the door open a bit by ending the note with

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

something about perhaps someday we could meet again. I still don't know if I did that to avoid sparing her feelings or allowing myself a chance to change my mind. Perhaps it was a little of both. I dropped the card in the mail.

About a month later she left me a voice mail like always and said she ho

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ped we could walk that Saturday. She didn't mention anything about receiving my card. I returned her message to let her know I was out of town and told her when I would be returning. That was three months ago and I haven't heard back.

I've been tempted to call my old friends a couple of times but th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e truth is I'm not interested in resuming a relationship. I still feel some guilt from time to time but I get over it by reminding myself that it's perfectly okay to spend time with the people I want to be around. I wouldn't want someone staying in a friendship with me out of a sense of guilt or obli

.

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

ation.

I researched volumes of advice about ending friendships. It helped me work through my confusion. The list above helped me see that we had grown apart. Maybe I'd changed, maybe she'd changed. Who's at fault didn't really matter. My connection to her had weakened.

I have lost friends, some by

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

death others through sheer inability to cross the street.
Virginia Wolf

After much soul searching I gave myself permission to walk away without carrying a long list of legitimate reasons to justify my decision. It felt wrong to continue this relationship. It felt right to end to it. Enough said

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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