World’s first biosimilar antibody is approved in Korea « New Drug Approvals

World’s first biosimilar antibody is approved in Korea « New Drug Approvals:



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Indian Biosimilars Market « New Drug Approvals

Indian Biosimilars Market « New Drug Approvals:



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Phase 3 data demonstrate comparability of Epirus’ BOW015 to Remicade for rheumatoid arthritis: « New Drug Approvals

Phase 3 data demonstrate comparability of Epirus’ BOW015 to Remicade for rheumatoid arthritis: « New Drug Approvals:



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FDA Approves Epanova for Severe Hypertriglyceridemia « New Drug Approvals

FDA Approves Epanova for Severe Hypertriglyceridemia « New Drug Approvals:



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Parasitic worms of pigs could provide new treatments of human diseases « New Drug Approvals

Parasitic worms of pigs could provide new treatments of human diseases « New Drug Approvals:



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Researchers investigate stress as a potential cause of periodontal disease « New Drug Approvals

Researchers investigate stress as a potential cause of periodontal disease « New Drug Approvals:



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Scientists take totally tubular journey through brain cells « New Drug Approvals

Scientists take totally tubular journey through brain cells « New Drug Approvals:



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The US Food and Drug Administration (FDA) has approved Bayer HealthCare’s Gadavist (gadobutrol) injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the US « New Drug Approvals

The US Food and Drug Administration (FDA) has approved Bayer HealthCare’s Gadavist (gadobutrol) injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the US « New Drug Approvals:



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Alternative solid-state forms of a potent antimalarial aminopyridine: X-ray crystallographic, thermal and solubility aspects « New Drug Approvals

Alternative solid-state forms of a potent antimalarial aminopyridine: X-ray crystallographic, thermal and solubility aspects « New Drug Approvals:



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Polymorphs and co-crystals of haloprogin: an antifungal agent « New Drug Approvals

Polymorphs and co-crystals of haloprogin: an antifungal agent « New Drug Approvals:



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Drug solid solutions – a method for tuning phase transformations

 

Drug solid solutions – a method for tuning phase transformations

Amit Delori, Pauline Maclure, Rajni M. Bhardwaj, Andrea Johnston, Alastair J. Florence, Oliver B. Sutcliffe and Iain D. H. Oswald

CrystEngComm, 2014, 16, 5827 DOI:10.1039/C4CE00211C

 

 This paper describes a methodology for the modification of phase transition temperatures using (±)-4′-methylmethcathinone solid solutions as an exemplar. This method serves to show that by varying the composition of the halide ion one can systematically alter the temperatures at which phase transitions can occur in order to evade the possibility of interconversion between polymorphs during processing or storage of materials.

 

 

 read at

 

 

 http://pubs.rsc.org/en/Content/ArticleLanding/2014/CE/C4CE00211C?utm_medium=email&utm_campaign=pub-CE-vol-16-issue-26&utm_source=toc-alert#!divAbstract

Drug solid solutions – a method for tuning phase transformations

Amit Delori,^a   Pauline Maclure,^a   Rajni M. Bhardwaj,^a   Andrea Johnston,^a   Alastair J. Florence,^a   Oliver B. Sutcliffe^b and   Iain D. H. Oswald*^a  

Show Affiliations

*Corresponding authors

^aStrathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS), University of Strathclyde, 161 Cathedral Street, Glasgow, UK G4 0RE
E-mail: iain.oswald@strath.ac.uk;
Fax: +44 (0)141 552 2562 ;
Tel: +44 (0)141 548 2157

^bSchool of Science and the Environment, Manchester Metropolitan University, Chester Street, Manchester, UK M1 5GD
E-mail: o.sutcliffe@mmu.ac.uk;
Fax: +44 (0)161 2476840 ;
Tel: +44 (0)161 2471531

CrystEngComm, 2014,16, 5827-5831

DOI: 10.1039/C4CE00211C

Requirements for Process Validation of Biotech Active Pharmaceutical Ingredients (APIs)

 

Introduction

Process validation of Active Pharmaceuti-

cal Ingredients (APIs) is still one of the

most challenging topics for both pharma-

ceutical industry and regulatory authorities. It

is the clear expectation of regulatory authori-

ties, especially the FDA and EMEA, that pro-

duction processes, cleaning procedures, ana-

lytical methods, computer and utility systems

that have an impact on product quality and

purity are validated. Facilities and equipment

used in conjunction with production and testing

of APIs must be qualified. T
http://www.eurotherm-danmark.dk/medic/pharma_doc/press_release/ispe_reprint_process_validation.pdf

Inhibiting Protein Aggregation

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The Biochemistry of Peppers – Part 2

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AMUVATINIB « New Drug Approvals

AMUVATINIB « New Drug Approvals:



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