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GMP Oversight of Medicines Manufacturers in the European Union
DRUG REGULATORY AFFAIRS INTERNATIONAL A System of Equivalent Member States, a Coordinating Agency and a Centralized Institution The regulatory system for supervision of pharmaceutical manufacturers...
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Istradefylline
Istradefylline, KW-6002 (Nouriast®) Approved A selective adenosine A2A receptor antagonist used to treat Parkinson’s disease. KW-6002 CAS No. 155270-99-8 Istradefylline; 155270-99-8; KW-6002; KW 6002;...
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Idarucizumab
Idarucizumab (Praxbind®) Approved An antidote for rapid reversal of dabigatran-induced anticoagulation indicated for emergency surgery (urgent procedures) and life-threatening or uncontrolled bleeding...
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Cymipristone
Cymipristone (8S,11R,13S,14S,17S)-11-{4-[Cyclohexyl(méthyl)amino]phényl}-17-hydroxy-13-méthyl-17-(1-propyn-1-yl)-1,2,6,7,8,11,12,13,14,15,16,17-dodécahydro-3H-cyclopenta[a]phénanthrén-3-one...
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FDA releases draft guidance on the use of comparability protocols for post...
DRUG REGULATORY AFFAIRS INTERNATIONAL The US FDA released a draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”. The...
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Five new General Chapters in the European Pharmacopoeia on Genotoxic...
DRUG REGULATORY AFFAIRS INTERNATIONAL During the manufacture of APIs as sulfonate salts, esters of sulfonic acid may develop in undesired chemical side reactions. Recently, five new General Monographs...
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New FDA Draft Guidance ‘Data Integrity and Compliance with cGMP’ published
DRUG REGULATORY AFFAIRS INTERNATIONAL In the last years, the topic “data integrity” has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the...
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Cebranopadol hemicitrate, セブラノパドール
Cebranopadol hemicitrate, GRT-6005 Phase III Grünenthal GmbH innovator SYNTHESIS COMING WATCH OUT………. A mu-opioid agonist for treatment of neuropathic pain and pain due to osteoarthritis. CAS...
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Boldenone Undecylenate
Boldenone Undecylenate cas 13103-34-9, C30 H44 O3, 452.67 Androsta-1,4-dien-3-one, 17-[(1-oxo-10-undecenyl)oxy]-, (17β)- Androsta-1,4-dien-3-one, 17β-hydroxy-, 10-undecenoate (7CI,8CI)...
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Quality Documentation of API mix in the Marketing Authorisation Procedure
DRUG REGULATORY AFFAIRS INTERNATIONAL For different reasons, the manufacture of APIs may sometimes require adding excipients. In the context of an authorisation procedure, this practice reveals to be...
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EMA publishes finalised Process Validation Guideline for Biotech Products
DRUG REGULATORY AFFAIRS INTERNATIONAL Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been...
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Processes for Constructing Homogeneous Antibody Drug Conjugates
Antibody drug conjugates (ADCs) are synthesized by conjugating a cytotoxic drug or “payload” to a monoclonal antibody. The payloads are conjugated using amino or sulfhydryl specific linkers that react...
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Buthionine Sulphoximine
Buthionine Sulphoximine NDA Filed in china A gamma-glutamylcysteine synthetase inhibitor potentially for the treatment of solid tumors. NSC-326231; BSO CAS No. 5072-26-4 BUTHIONINE SULFOXIMINE;...
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EMA’s new Draft Guideline on the Sterilisation of Medicinal Products, APIs,...
DRUG REGULATORY AFFAIRS INTERNATIONAL For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA...
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USP publishes draft of a new general chapter for plastic components used in...
DRUG REGULATORY AFFAIRS INTERNATIONAL In the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters – Packaging and Distribution Expert Committee proposes a new general chapter...
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APIs from Legitimate and Reliable Sources
DRUG REGULATORY AFFAIRS INTERNATIONAL APIs from Legitimate and Reliable Sources 1. Introduction Counterfeit and sub-standard APIs are increasingly present. Not only are they a fact of non-compliance...
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7th Annual Clinical Trials Summit 2016, 24th May 2016, The Lalit Hotel,...
“7th Annual Clinical Trials Summit 2016” “A critical guide for successfully conducting clinical...
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CDRI 830
CDRI 830 CDRI S006-830 N-[2-[4-[(4-methoxyphenyl)-thiophen-2-ylmethyl]phenoxy]ethyl]-N-propan-2-ylpropan-2-amine Molecular Formula: C26H33NO2S Molecular Weight: 423.61072 g/mol CDRI-830 of thiophene...
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ICH M8 “Specification for Submission Formats for eCTD”
DRUG REGULATORY AFFAIRS INTERNATIONAL This additional specification describes the way files should be constructed for inclusion in the eCTD. Key Points: It is not necessary to use a product from Adobe...
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