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Single-Use Equipment ...

It's the users in biopharma who will benefit from ...

8 comments

No Nonsense Computer Systems ...

ISPE's GAMP is a useful guide, but may not be practical ...

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Product Volume & API Process ...

API manufacturing processes can be complex and ...

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FDA Crackdown on Compounders: Too ...

The FDA now admits that it could have done more to ...

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Changing Pharma’s Negative ...

Former Pfizer R&D chief John Lamattina proposes some ...

29 comments

ICH Q11 & Stealth QbD for Drug ...

Last May, ICH Q11 came on the scene without much hoopla, ...

6 comments

What's in Your Risk Policy?

Pharma is finally moving away from a check-the-box ...

8 comments

Quality & Risk Management: Beware ...

Never underestimate the complexity of pharmaceutical ...

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Illicit Designer Drugs: The ...

If the FDA were also given oversight of illegal drugs, ...

9 comments

So You Think You Know Lean?

Do you understand Toyota Production System concepts and ...

6 comments

Understanding Pharma Patents

Pharma's patent cliff is redefining the industry. Here, ...

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Question-Based Review, APIs & the ...

Question-Based Review could be a way to help ensure the ...

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Pharma Evolution Blogs

A Spoonful of Sugar

Adele Graham-King, Blogger, 17/05/13 Comment now

When I was young, we were given our polio vaccine on a sugar cube. We were given medicines full of sugar, we held our noses to take nasty suspensions, and we were regularly pinned down by our parents to ensure that we took the horrid ...

Latest comment Emil, I think it's a valid point about not masking the taste and certainly making medication too sweet. And the 'Child resistant closure'...

Making New Drugs, Not Patients, the Guinea Pigs

Agnes Shanley, Editor-in-Chief, 16/05/13 Comment now

In traditional clinical medicine, patients are guinea pigs for new drugs. The risk of adverse -- or no -- effects is the price we pay for the potential of receiving treatment. But for those with terminal illnesses, even this risk is out ...

Latest comment I sure hope this venture is sucessful. Needy patients miss opportunities to participate in clinical trials that may save their lives....

PharmaEvolution Case Files 4

Agnes Shanley, Editor-in-Chief, 15/05/13 Comment now

Who is advancing a smarter approach to pharma, and who isn't? Here's a look at those who have spurred positive change, and those who haven't.

Latest comment I think Dinesh received a justified reward for doing good. There are not enough examples of reward for good behavior in this world...

Are You Smarter Than an FDA, EMEA, or PIC/S Inspector?

Barry A. Friedman, PhD, Independent Consultant, 15/05/13 Comment now

No offense intended to the diligent and well-educated staff of the FDA and other global regulatory bodies, but, as our previous blog post suggests, there may be less precision than there should be in written facility observations. ...

Latest comment I wonder how an inspector would score on this cGMP test.

Are Regulators Missing Opportunities for Greater Clarity on Aseptic Requirements?

Barry A. Friedman, PhD, Independent Consultant, 14/05/13 Comment now

Ever wonder how FDA's Office of Regulatory Affairs (ORA) selects the most appropriate plant observations? Each year FDA's CDER summarizes the number of significant observations obtained from Form FDA 483s. The observations cited within ...

Latest comment I think it is a scary thought that our trusted FDA regulators are missing opportunities to clarify their regulatory language on aseptic...

Improving APIs & Formulation: Are You Harnessing the Power of Liquids?

Girish Malhotra, President & Founder, Epcot International, 14/05/13 Comment now

Liquids are an essential part of our planet. Imagine our landscape and lives without them. We may take them for granted, but liquids play an important role in the reactive processes that produce small molecule active pharmaceutical ...

Latest comment This is a good review of basic solvent chemistry. I wonder how many industry professsionals are, in fact. "harnessing the power of...

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Most Commented

Thriving, Not Just Surviving, in a World of Constant Change

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Changing Pharma’s Negative Public Image

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Pharmaceutical Quality: Our Platform's Not Burning, It's Leaking!

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Will US Senate Track & Trace Proposal Really Protect the Supply Chain?

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Why Face Time With Regulators Is Critical to PAT/QbD Success

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Data Mining Can Be Dangerous Work

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Blogs Archive

Video Blogs

Jacobs GVP Bob Pragada on the ...

Bob Pragada, Group VP of Jacobs, shares a vision of the ...

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California's e-Pedigree ...

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Aseptic Equipment Trends

IPS's Jason Collins on key trends, such as reducing ...

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Russ Somma on Tableting & ...

Sommatech consultant Russ Somma discussed trends in ...

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A Look at Interphex 2013

Highlights from the pharma exposition and conference ...

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On the Floor at Interphex 2013: ...

We follow biopharm tour guide Chuck Stock and view some ...

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Rajesh Nair on Meeting Change Head-On

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IPS's Jeff Odum on the ...

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PharmaEvolution.com Launch Party

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Sociochemicology

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Supply Chain Management Has to ...

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Video Archive

Message Boards

Adele Graham-King 5/19/2013 9:33:38 AM
A Spoonful of Sugar
Re: spoonful of sugar:
Emil, I think it's a valid point about not masking the taste and certainly making medication too sweet. And the 'Child resistant closure' (CRC) is a different issue. If we could create a user friendly, anti-spill, accurate child suspension delivery device this would aid in optimum...

Emil W. Ciurczak 5/19/2013 9:09:49 AM
A Spoonful of Sugar
spoonful of sugar:
One cautionary note: since there is no such thing as a "child-proof" cap, we shouldn't make the meds too tasty...the potential for a child (or elderly patient) mistaking it for a "snack" exists. Some medium should be found between "horrible" and "yummy."

Emil W. Ciurczak 5/19/2013 9:04:25 AM
Jacobs GVP Bob Pragada on the Pharma Facility of the Future
Future of Pharma:
Even in regions of the world where it has been lees expensive to manufacture an API of final product, rising labor and material costs (plus competition for trained employees) are causing companies to search for labor and material-saving production techniques. Apparently, economics,...

Adele Graham-King 5/18/2013 3:28:10 AM
A Spoonful of Sugar
Re: dosage vs dispensing :
@s1234macdougall I agree that the pharmacist should be responsible for tailored individual dispensing and can give assistance in administration, but the care giver must be armed with the information and training to competently and safely deliver medication (be that clinically...

Adele Graham-King 5/18/2013 3:17:53 AM
A Spoonful of Sugar
Re: Drug delivery for children:
Agnes - I completely agree and I'm known to rant about this with regularity! The unpredictability of behaviour which always alters with the presentation of pink liquid makes it extremely difficult, and that's just the active ingredient, never mind the method of delivery. And, as...

s1234macdougall 5/17/2013 7:06:19 PM
A Spoonful of Sugar
dosage vs dispensing :
Don't leave it up to the care giver to administer dosage. The pharmacist should dispense on an individual basis

s1234macdougall 5/17/2013 6:49:06 PM
Write a Funny Caption, Win a Prize
Import/export:
What should we say this one does!?!?

Agnes Shanley 5/17/2013 2:54:49 PM
A Spoonful of Sugar
Drug delivery for children:
Developing delivery systems that will ensure compliance and the correct dosage for children is not as easy as it might seem, as the formulation case study for dysphagia showed. Then there is the entirely separate subject of flavor masking (ideally, not with tons of sugar). This...

Girish Malhotra 5/17/2013 7:40:51 AM
Product Volume & API Process Optimization: Connecting the Dots
Re: Pioneers in Single-Plant Processing?:
Making a switch is not mandatory. It is an opportunity. Each company has to consider it. A strong player who has made the switch could force others out of business for that particular API. You suggest switch is not simple. Unless one tries it no one would know the value. No...

Kerstin Carson 5/17/2013 2:25:48 AM
No Nonsense Computer Systems Validation: Covering All Bases
Re: Computer Systems Validation is a Recurring Problem in FDA Inspections :
While reading the CSV checklist, I was quickly reminded of a business plan. In order for a company to establish itself as a profitable enterprise, it needs a focused plan to help them make steady (and steadily increasing) profits. Likewise, those in pharmaceutical development and...

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