| Subject | Date Asked | Expert |
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| Which medicine is more effective? | 11/15/2009 | Dr Mohd Tariq Salman |
Q: I have Stage III-C clear cell endometrial carcinoma and I start chemo on Nov.17th. My oncologist has ...
A: Ativan (lorazepam) is indicated for the management of anxiety. For optimal results, dose, frequency ...
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| Raw material testing | 11/4/2009 | Michael Anisfeld |
Q: Reading guidelines about raw material testing for the pharmaceutical industry, I often find the word ...
A: The amount of testing is based on the supplier history and your confidence in the Supplier's ...
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| Required pressure on manometers | 10/30/2009 | Michael Anisfeld |
Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ...
A: Why do you need to read pressure in warehouses? The key issue is temperature. If you are trying to ...
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| Retain Samples | 10/28/2009 | Michael Anisfeld |
Q: I am trying to determine if there are any rules FDA/Foreign that would require a retain sample for ...
A: Interesting questions. 21CFR211.170 on Reserve Samples states: "(b) An appropriately identified ...
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| Off-label prescriptions | 10/27/2009 | Michael Anisfeld |
Q: I know that the FDA cannot regulate a physician's prescribing FDA approved drugs for off-label uses, ...
A: Claire: You appear to be correct (but as I am not a lawyer, I cannot state that you legally "are ...
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| MAP OF DEDICATED WARE HOUSE (RAW , PACKING AND F/G ) | 10/26/2009 | Michael Anisfeld |
Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ...
A: There is no such thing as the "ideal" warehouse, as it depends on your product needs (degree of ...
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| Choosing between different drug manufacturing companies | 10/15/2009 | Dr Mohd Tariq Salman |
Q: india. Few monthes ago i was prescribed escitalopram when i was in Saudi Arabia and they gave it to ...
A: you can take any brand as long as it is from a reputed company and you buy it from a reliable drug ...
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| Raw Material Sampling | 10/15/2009 | Michael Anisfeld |
Q: Is there any guideline which cites the quantity for Raw material sampling? Or from where this root ...
A: You are asking two different questions. For chemicals you need to sample sufficient material to ...
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| API | 10/13/2009 | Michael Anisfeld |
Q: my question is how we give expiry date to a finished dose form product, and if we have an API lot ...
A: With the exception of products sold in India (they have a unique interpretation of API stability and ...
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| Temperature and humidity requirement for multi vitamins and pharmaceutical excepients | 10/5/2009 | Michael Anisfeld |
Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ...
A: The temperature/humidty requirements required in your warehouse will relate to what you are storing. ...
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| Need information relating to interactions | 10/1/2009 | Dr Mohd Tariq Salman |
Q: I take 0.5mg of Alprazolam (Xanax) 2x per day for anxiety. I also deal with kidney stone pain ...
A: There are major drug-drug interactions between the two. The combination can be dangerous for some ...
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| Ideal and dedicated map of raw , packing ang finished goods stores in pharmaceutical industry | 9/29/2009 | Michael Anisfeld |
Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ...
A: You need separate areas for: a. goods receipt (unloading dock) b. raw material sampling area (a ...
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| GMP Specifications for Relative humidity and temperature. | 9/28/2009 | Michael Anisfeld |
Q: Please what are the various classes of areas in the pharmaceutical manufacturing plant with ...
A: According to the USP (Genral Notices), the following definitions apply: Freezer— A place in which ...
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| Stability testing pulling times | 9/28/2009 | Michael Anisfeld |
Q: I was wandering whether you could help with my query relating to stability testing of ...
A: The answers you seek were covered in an FDA OGD Guideline, withdrawn a few years ago. Samples with ...
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| Wellbutrin & Adderall | 8/16/2009 | Dr Mohd Tariq Salman |
Q: Salman, My brother was prescribed WELLBUTRIN (bupropion) recently for two reasons. First, to help ...
A: The use of bupropion is associated with a dose-related risk of seizures. The risk may be increased ...
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| pharmacuetical possible use for anxiety | 7/24/2009 | Dr Mohd Tariq Salman |
Q: I am currently taking 30mg amphetamine/dextroamphetamine (Adderall xr) for ADHD and have very high ...
A: Acetaminophen and hydrocodone is basically a pain reliever. Since your headache was relieved, it ...
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| Wellbutrin XL 225mg | 7/3/2009 | Dr Mohd Tariq Salman |
Q: For a few years I've been taking Wellbutrin XL at one of two dosages for months at a time, 150mg or ...
A: Wellbutrin XL 225mg is not available anywhere in the world. Wellbutrin XL and Wellbutrin SR are ...
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| Men's Health | 7/2/2009 | Dr Mohd Tariq Salman |
Q: Is propecia safe?
A: All drugs may cause side effects and you have to weigh the potential benefits versus the potential ...
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| Pharmaceuticals | 7/2/2009 | Michael Anisfeld |
Q: Have a nice Day My question is: Can we give Retesting date to Raw Material beyond its expiry date ...
A: The only GMP providing guidance on this, worldwide, is the Canadian GMPs. They state that if the ...
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| Pharmaceutical Industry | 7/1/2009 | Dr Mohd Tariq Salman |
Q: What would happen to the Pharmaceutical Industry, especially someone who has M.S. in Pharmaceutical ...
A: Pharmaceutical Industry is an evergreen field and one of the industries which are least effected by ...
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| Wellbutrin dose | 6/30/2009 | Dr Mohd Tariq Salman |
Q: Over the years I have taken two different dosages of Wellbutrin XL: 150 and 300 mg. I've generally ...
A: instead of WELLBUTRIN XL you can take WELLBUTRIN SR 100 mg twice daily. This will give you 200mg ...
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| Expiry date vs date of manufacture vs shelf life | 6/24/2009 | Michael Anisfeld |
Q: My question is regarding expiry dating which is usually expressed as month and year. If a pharma ...
A: Kevin: The date of manufacture is the date that the ingredients first get to meet each other, say ...
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| Reprocess of nearing expiry drug substance | 6/22/2009 | Michael Anisfeld |
Q: One of my friends wants to reprocess the nearing expiry drug substance. If he does, then What would ...
A: you can do this on two conditions: a. you have stability data (at a minimum 6 months accelerated ...
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| pharmacy related | 6/16/2009 | Dr Mohd Tariq Salman |
Q: actually i m here at onsite and i have tab of erythromycin of government supply of mfg date of ...
A: expiry date depends on salt active ingredient used, type of tablet and manufacturer. In this case ...
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| Nitrofur | 6/13/2009 | Dr Mohd Tariq Salman |
Q: Should a woman who is taking Nitrofur continue to breastfeed an infant who is two weeks old? What ...
A: Nitrofurantoin is excreted into human milk. It is considered compatible with breast-feeding by ...
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| drug interactions with methadone | 6/8/2009 | Dr Mohd Tariq Salman |
Q: what are the drugs that you cannot take while on methadone? I know there are some that will start
A: 1. Opioid Antagonists, Mixed Agonist/Antagonists, and Partial Agonists Patients maintained on ...
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| Antibiotics | 6/4/2009 | Dr Mohd Tariq Salman |
Q: . I recently had my wisdom teeth (all 4) pulled. that went well so far and i haven't had any issues. ...
A: You are most probably having oral candidiasis, which develops due to alteration of normal oral ...
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| Microbiological testing of pharmaceutical stability samples | 11/5/2008 | Michael Anisfeld |
Q: I saw your answer regarding the frequency of testing for stability and wonder if microbiological ...
A: If the study is to establish an expiration date for a new product, then microbial testing is ...
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| zaleplon | 10/30/2008 | Michael Anisfeld |
Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ...
A: Humble and profuse apologies. I was mixing the drug in my mind with Zolpidem (sold here as Ambien) ...
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| zaleplon | 10/29/2008 | Michael Anisfeld |
Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ...
A: Zaleplon is sold in the USA as Ambien. It is banned in Canada and is not available there. I ...
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| Vertical form fill seal machines | 10/7/2008 | Michael Anisfeld |
Q: We are trying to place powdered nutritional supplements into a 3 or 4 sided pouch. It is a fine ...
A: Vicki: Many moons ago I used to run a powder fill line for pharmaceutical products, and will share ...
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| microbiological testing in pharmaceuticals | 9/23/2008 | Michael Anisfeld |
Q: Can I get rid off Autoclave if I use 'ready to use media / plates/ tubes' in the microbiological ...
A: JK: I wish you could, but have you thought about how you will decontaminate the growth plates after ...
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| Brand Name Synthroid vs. Generic | 9/22/2008 | Michael Anisfeld |
Q: My doctor, who I respect, and his entire endocrinology practice at a major Baltimore hospital, ...
A: As the FDA has approved generic Synthroid as bio-equivalent to the original brand, you will have a ...
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| Freeze Thaw Study | 9/20/2008 | Michael Anisfeld |
Q: I would like to know how is freeze/thaw study carried out for Liquid oral products with references, ...
A: Take your liquid product, cool at -5oC to freeze, and hold frozen for 24 hours; then thaw at room ...
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| Drug Safety | 9/18/2008 | Michael Anisfeld |
Q: I get extremely intense anxiety when flying on airplanes. A few years ago, I went to a doctor and ...
A: All drugs degrade from the date of manufacture, losing effectiveness and potentially building up ...
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| Clonidine and Atenolol manufacturing | 9/12/2008 | Michael Anisfeld |
Q: I have a question about these two medications. My mother takes both for her high blood pressure and ...
A: Sheryl: Welcome to the wonderful world of generic drugs. When the product patent expires, ...
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| Quality Index in pharmaceuticals | 8/21/2008 | Michael Anisfeld |
Q: What is quality index.pls give the importance of it.Is their any reference for this.
A: There is no uniform definition, and many people use the term in may different ways. As examples, ...
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| writing the dossier when only CEP is available | 8/12/2008 | Michael Anisfeld |
Q: I have a problem, I need to write a registration documentation in EU format (not CTD) - the IIF ...
A: I commiserate with you, having been in the same situation a few years back. The EU reviewers demand ...
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| stability/balance calibration | 7/26/2008 | Michael Anisfeld |
Q: stability what to do if our product shows significant change in accelerated condition calibration ...
A: stability - by "change" in stability - do you mean that the product does not meet its specification ...
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| generic drugs -- not quite the same | 7/23/2008 | Michael Anisfeld |
Q: Are you aware, that by law, generic drugs do not have to bioidentical? Meaning they can contain ...
A: Lori: Sorry, but I completely disagree with you. According to the Good Manufacturing Practices ...
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