Montague T.H.,Glaxosmithkline |
Potvin D.,Theratechnologies |
Diliberti C.E.,Montclair Bioequivalence Services LLC |
Hauck W.W.,Pharmacopeia |
And 2 more authors.
Pharmaceutical Statistics | Year: 2012
In 2008, this group published a paper on approaches for two-stage crossover bioequivalence (BE) studies that allowed for the reestimation of the second-stage sample size based on the variance estimated from the first-stage results. The sequential methods considered used an assumed GMR of 0.95 as part of the method for determining power and sample size. This note adds results for an assumed GMR = 0.90. Two of the methods recommended for GMR = 0.95 in the earlier paper have some unacceptable increases in Type I error rate when the GMR is changed to 0.90. If a sponsor wants to assume 0.90 for the GMR, Method D is recommended. Copyright © 2011 John Wiley & Sons, Ltd.
Theratechnologies | Date: 2012-10-18
Peptide compounds derived from human melanotransferrin, and compositions thereof, are described. Uses of these peptide compounds, for example to modulate angiogenesis and/or cell migration, and/or to treat angiogenesis-related disorders (e.g., cancer), are also described.
Theratechnologies | Date: 2013-03-14
Stabilized solid and liquid pharmaceutical formulations comprising a GRF molecule as active ingredient, such as GRF analogs including those comprising an N-terminal-attached hydrophobic moiety, such as [trans-3-hexenoyl]hGHRH (1-44) amide, are disclosed. The formulation comprises a GRF molecule or a pharmaceutically acceptable salt thereof and a -cyclodextrin which is not conjugated to the GRF molecule or salt thereof. Also disclosed is the use of the formulation for the treatment of various conditions, methods of preparing the formulation, as well as kits containing it. Methods of stabilizing (e.g., with respect to chemical stability) such GRF molecules, as well as methods of inhibiting their deamidation at Asn
Theratechnologies | Date: 2011-07-07
The invention relates to use of a GH secretagogue (e.g. GRF or an analog thereof) for (1) altering a lipid parameter in a subject; (2) altering a body composition parameter in a subject, (3) treating a condition characterized by deficient or decreased bone formation in a subject (4) improving daytime vigilance and/or cognitive function in a subject, (5) improving a metabolic condition in a subject, (6) improving anabolism in a catabolic condition in a subject, and/or (7) improving and/or reconstituting immune function in a subject.
Theratechnologies | Date: 2011-01-11
The invention relates to use of a GH secretagogue (e.g. GRF or an analog thereof) for increasing muscle function in a subject. Also disclosed herein are corresponding methods, packages and compositions.