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    Academic Journals

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• Select Meeting Challenges in Solid-Dose Packaging: Innovations address supply-chain constraints, serialization, and new requirements for sustainable and patient-centric designs.

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  Meeting Challenges in Solid-Dose Packaging: Innovations address supply-chain constraints, serialization, and new requirements for sustainable and patient-centric designs.

  Author:Hallie ForcinioFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20221,701 words Article 1440LSolid-dosage forms continue to play an essential role in the pharmaceutical marketplace despite the attention the COVID-19 pandemic has focused on parenteral products. Factors spurring demand for solid-dose products...
• Select A Future Investment.

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  A Future Investment.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 2022457 words Article 1510LAntimicrobial resistance (AMR) has long been on the radar of global organizations as a serious threat to human health. However, there are few potential antimicrobials in the clinical development pipeline, and a...
• Select Breaking Through Barriers to Continuous Manufacturing: Collaboration and new tools aid efforts to implement new processing technologies for small-molecule drug product manufacturing.

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  Breaking Through Barriers to Continuous Manufacturing: Collaboration and new tools aid efforts to implement new processing technologies for small-molecule drug product manufacturing.

  Author:Jennifer MarkariaFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20222,776 words Article 1520LPharmaceutical manufacturing is inching towards implementing more efficient and sustainable processes, including continuous manufacturing (CM) of solid-dosage drugs. Advantages of CM include the potential for faster...
• Select Bringing Excipients into the Quality-by-Design Paradigm: Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

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  Bringing Excipients into the Quality-by-Design Paradigm: Although not easy to do, it is essential because excipients can affect drug-product safety and efficacy.

  Author:Cynthia A. ChallenerFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20222,491 words Article 1530LDrug products must be produced in a manner that ensures both their safety and efficacy. That requires consideration of the quality of all ingredients in a final formulation, including all excipients, whether they are...
• Select Cleanroom Cleaning: Proper Methodology and Determining Efficacy: Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.

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  Cleanroom Cleaning: Proper Methodology and Determining Efficacy: Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.

  Authors:Ryan Burke and Madison PriftiFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20221,789 words Article 1460LPreventing contamination within classified areas of an operational cleanroom is a constant battle. Cleaning and disinfection programmes help mitigate contamination by removing the microorganisms and particulates...
• Select Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2--Dissolution.

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  Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2--Dissolution.

  Author:Pramote CholayudthFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20222,392 words Article 1490LIn this second half of an article on how to best estimate the probability of passing multiple stage tests, the author introduces a practical approach to determining the best estimate for probability of passing the...
• Select Formulating the Best Approach for Tablets: An early formulation strateey for tablets that is simple and scalable is recommended to ensure fewer downstream problems.

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  Formulating the Best Approach for Tablets: An early formulation strateey for tablets that is simple and scalable is recommended to ensure fewer downstream problems.

  Author:Felicity ThomasFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20222,357 words Article 1350LThe oral solid dosage formulation market is anticipated to experience growth in the coming years, reaching an estimated worth of US$926.3 billion ([euro]831.8 billion) by the end of 2027 (1). Growth factors for the...
• Select Health Science: Health Inspired, Quality Driven.

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  Health Science: Health Inspired, Quality Driven.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 2022379 words Brief article 1490LNitrosamine Testing Solutions The presence of the nitrosamine, N-nitrosodimethylamine (NDMA), in certain sartan API's has resulted in several regulatory warnings and recall of contaminated products. Concerns over the...
• Select Verifying Compendial Methods: Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

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  Verifying Compendial Methods: Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

  From:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 2022842 words Article 1380LQ. Are compendial methods considered validated? A. According to the pharmacopoeias, compendial methods are validated--that's about as simple as it gets. The United States Pharmacopeia-National Formulary (USP-NF) states...
• Select Scaling Up Capacity for Cell Therapies: The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

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  Scaling Up Capacity for Cell Therapies: The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

  Author:Susan HaigneyFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20221,884 words Interview 1390LAs cell and gene therapies continue to grow as novel treatments for unmet medical needs, biopharmaceutical companies will need to assess their options for meeting production demand. Two categories of cell therapies...
• Select Considering Blow-Fill-Seal for Biologic Drugs: The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

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  Considering Blow-Fill-Seal for Biologic Drugs: The continuous, aseptic fill/finish process is finding use in vaccines and biologic drugs.

  Author:Jennifer MarkarianFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20221,868 words Article 1490LBlow-fill-seal (BFS) equipment has been widely used for many years in aseptic fill/finish of small-molecule and biologic liquid formulations, including nebulizer solutions for respiratory delivery and ophthalmic sterile...
• Select Put a Cap on CAPAs: Data may be used to improve (or remove) a corrective action/preventive action.

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  Put a Cap on CAPAs: Data may be used to improve (or remove) a corrective action/preventive action.

  Author:Sue MarchantFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20221,541 words Article 1190LBeing cautious is a good thing, especially when it comes to product quality and safety. Pharmaceutical companies, in particular, have to be aware of this. Products that can save patients' lives can adversely affect them...
• Select Major League Moves.

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  Major League Moves.

  Author:Mike Hennessy, Jr.From:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 2022414 words Article 1380LIf a major league team was guaranteed to lose half of its best players (by far) over the next few seasons, the outlook would be gloomy. Our industry will lose core patents on Humira, Keytruda, Revlimid, and Eliquis...
• Select Regulating Clinical Trials: In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?

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  Regulating Clinical Trials: In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?

  Author:Cheryl BartonFrom:Pharmaceutical Technology Europe (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 20221,091 words Article 1740LOn 31 Jan. 2022, the European Union (EU) initiated the three-year transition for member states to submit clinical trials under a new legal framework Clinical Trial Regulation 536/2014 (EU-CTR) which replaces Clinical...