Bioavailability Challenge

BE/BA sites must be logged with US FDA under GDUFA

28-Aug-2012 By Gareth Macdonald

CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.

FDA to develop GDUFA self-identification database; warns about ANDA backlog fee

27-Aug-2012 By Gareth Macdonald

The US FDA plans to establish a new database for manufacturing facilities required to ‘self-identify’ under new GDUFA laws.

Capsugel wants to standardise lipid formulation tests

22-Aug-2012 By Natalie Morrison

Capsugel has launched a non-profit consortium in a bid to establish a lipid formulation classification system.

Quotient & Capsugel partner on lipid formulation services

26-Jun-2012 By Natalie Morrison

Quotient and Capsugel have teamed up to tackle drug delivery challenges in lipid-based formulations with new assessment and development services.

Is drug delivery by skin the solution to bioavailability woes? report from Achema

21-Jun-2012 By Natalie Morrison

Drug regulators and the biomanufacturing industry need to embrace drug delivery via the skin to solve solubility problems with peptides and proteins, according to Across Barriers’ Udo Bock.

P-Gels mean cheaper and more varied drug development, says Patheon

31-May-2012 By Natalie Morrison

Patheon says its new soft gel platform is creating cheaper development opportunities for drugsmakers.

BASF renames solubilisation and dermatology excipients

12-Apr-2012 By Gareth Macdonald

BASF has developed a new naming scheme for the solubilisation and dermatology excipients it gained with the acquisition of Cognis.

Catalent and BASF team up to solve the bioavailability problem

05-Apr-2012 By Natalie Morrison

Catalent and BASF have joined forces to tackle bioavailability challenges from feasibility studies to commercial supply.

Pharma must improve existing methods to boost solubility as “quantum leap” unlikely

15-Nov-2011 By Nick Taylor

To boost solubility pharma must develop, refine and improve existing methods as a “quantum leap” in formulation is unlikely, Pharmaterials' CEO said.

BASF talks excipients, raw materials and development plans at CPhI 2011

31-Oct-2011 By Gareth Macdonald

BASF says solubility and bioavailability will be key focus for its pharmaceutical excipient product development efforts in the next few years.

Pii eyes gelatin shell evolution to enhance oral drug delivery

26-Oct-2011 By Nick Taylor

Pii is developing small intestine targeting drug delivery technologies as part of a focus on gelatin shell materials.

Pii adds trial scale HME capacity

28-Jul-2011

Pharmaceutics International (Pii) has expanded its range of formulation and process development services with the addition of bioavailability boosting hot-melt extrusion (HME) capabilities.

DCGI suspends Axis Clinicals’ research license

28-Jun-2011 By Gareth Macdonald

India’s DCGI has banned CRO Axis Clinicals from conducting bio-availability and bio-equivalence studies at its facility in Miyapur, Hyderabad.