Abstract: The invention relates to pharmaceutical compositions comprising leukotoxin, including methods to treat lymphoma, and methods to diagnose lymphoma. The lymphoma includes lymphoma cells expressing activated LFA-1, and the leukotoxin binds to the activated LFA-1 on the lymphoma cells and destroys the lymphoma cells by apoptosis or necrosis, thereby treating said lymphoma.

Abstract: The invention relates to medicine, namely to the antimicrobial agent for the treatment of infectious bacterial diseases including hospital infections and drug-resistant TB which represents the ion nanostructured complex (INSC) synthesized from carbohydrates proteins and/or polypeptides (albumins, interleukins, interferons, signaling proteins, etc), which are to enhance the antimicrobial activity in vivo, by activating immune cells that contain at least one terminal amino acid such as Phe, Ala, Val, Ala, Leu, Ile, and others with electron-donor functional groups, iodine and halides of the alkali and alkaline earth elements in the fourth stage at a certain ionic strength; an antibacterial agent increases: the susceptibility of bacteria, including antibiotic-resistant, to antibiotics; activity of monocytes and macrophages; efficiency of antibiotic treatment of hospital infections and drug-resistant TB; it also has antiviral activity, stimulates hematopoietic function of bone marrow; has an antitumor effect and r

Abstract: A method for improving the performance of a subject or for improving digestibility of a raw material in a feed (e.g. nutrient digestibility, such as amino acid digestibility), or for improving nitrogen retention, or for improving dietary phosphorus absorption and retention, or for improving the efficacy of the phytase, or for improving the subject's resistance to necrotic enteritis or for improving feed conversion ratio (FCR) or for improving weight gain in a subject or for improving feed efficiency in a subject or for modulating (e.g. improving) the immune response of the subject or for reducing populations of pathogenic bacteria in the gastrointestinal tract of a subject, or for reducing nutrient excretion in manure, which method comprising administering to a subject at least one direct fed microbial in combination with a phytase, wherein the phytase is administered to the subject at a dosage of more than about 1500 FTU/kg feed.

Abstract: Disclosed herein are compositions and methods for treating celiac sprue.

Abstract: Methods for modifying progression of osteoarthritis by local administration of a clostridial derivative, such as a botulinum toxin, to an arthritis-affected site are disclosed herein.

Abstract: Methods are described for the isolation and selection of a heterogeneous bone marrow cell population, called NCS-01, that is effective at treating neurodegeneration. For example, NCS-01 cells are shown to treat neurodegeneration caused by ischemia. In vivo studies demonstrate that selected NCS-01 cell populations treat neurodegeneration in a standard rat middle cerebral artery occlusion (MCAO) animal model under conditions of transient or permanent total arterial occlusion. These studies also disclose that when the neurodegeneration is caused by ischemic stroke, combining the administration of a selected NCS-01 cell population with thrombolytic agents and/or mechanical methods of clot removal leads to a decrease in the volume of infarction caused by acute onset neurodegeneration. The disclosed cell therapy promises to make a significant clinical impact on patient survival after stroke.

Abstract: Described herein is an association of at least one phosphate binder, at least one uremic toxin binder, at least one vasoactive antihypertensive agent and at least one antifibrotic agent for the management of progressive renal diseases including chronic kidney diseases (CKD) in domestic carnivores. Specifically, the application describes veterinarian compositions comprising such an association and the use thereof for the treatment of CKD conditions.

Abstract: The invention provides for the synthesis of more effective generators of a T-cell immune response by providing peptide derivatives that are MHC class I-restricted antigens. The peptide derivatives of the present invention are prepared or derived from a parent peptide of 8 to 11 amino acid residues in length, wherein the peptide derivative contains a non-natural amino acid substituted in place of a naturally-occurring amino acid residue at one or more primary anchor positions in the parent peptide or at position 6, position 7, or the C-terminus.

Abstract: A device that includes a scaffold composition and a bioactive composition with the bioactive composition being incorporated into or coated onto the scaffold composition such that the scaffold composition and/or a bioactive composition controls egress of a resident cell or progeny thereof. The devices mediate active recruitment, modification, and release of host cells from the material.

Abstract: Provided herein are methods and compositions for the treatment of melanoma using anti-tumor immune cells treated with a PTD-MYC fusion protein (e.g., an HIV TAT-MYC fusion protein).

Abstract: This two-step method used in the Clostridium difficile toxin transport is a unique method of delivery. The use of a vaccine (TAA/ecdCD40L) for the interdiction of this two-step delivery toxin system to reduce cell death and the death of human subjects is believed to be unique in the area of neutralizing antibodies for protection against the lethal effects of an infectious agent. The proposed composition/vaccine strategy for C difficile is to combine and administer at the same time the two compositions/vaccines for Toxin A, the one composition/vaccine for Toxin B and the one vaccine for CDTb to determine the effect of mixing these compositions/vaccines on protecting mice from a lethal dose of C difficile. This is believed to be the first time that two different tandem repeats from the contact of a ligand with its cellular receptor have been used to prevent binding of the ligand to its cellular receptor.

Abstract: The disclosure provides immunogenic compositions comprising a polypeptide comprising a C-lobe domain or an N-lobe domain of a HIBP surface receptor protein obtainable from or obtained from a Gram-negative bacterial species. The HIBP surface receptor proteins have been modified in such a manner that they are unable to bind host iron binding protein. Methods of making and using these immunogenic positions to prepare animal and human vaccines are also provided.

Abstract: Influenza vaccines include hemagglutinin from at least one influenza A virus strain and at least one influenza B virus strain. They also include an oil-in-water emulsion adjuvant with submicron oil droplets, comprising squalene. In some embodiments the hemagglutinin concentration is >12 ?g/ml per strain. In some embodiments the squalene concentration is <19 mg/ml. In some embodiments the vaccine is mercury-free. In some embodiments the vaccine has a unit dose volume between 0.2-0.3 mL. In some embodiments the squalene concentration is 9.75 mg/mL or 4.88 mg/mL. In some embodiments the vaccine includes antigens from two influenza A virus strains and two influenza B virus strains.

Abstract: In certain aspects the invention provides HIV-1 immunogens, including envelopes (CH505) and selections therefrom, and methods for swarm immunizations using combinations of HIV-1 envelopes.

Abstract: Disclosed are an antibody (preferably a fully human antibody R66) against respiratory syncytical virus RSV, encoding nucleic acids thereof, a vetor and a host cell comprising the same, and a preparation method thereof. Disclosed are also a use of the antibody (preferably a fully human antibody R66) against RSV in the prevention and treatment of RSV-related diseases, and a use of the same in detecting TSV. The above antibody against RSV is preferably a fully human monoclonal antibody. Compared with other animal-derived (e.g., murine) anti-RSV antidodies, the immunogenicity caused by species differences is greatly reduced. With good specificity and affinity, if used for clinic, it will greatly reduce side effects.

Abstract: Mixed allergen compositions of one, two or more different allergens are provided. In some instances, the mixed allergen compositions include: a nut allergen; an animal allergen; and at least one of: a non-nut plant allergen; a biotic agent; and a vitamin. Also provided are methods of administering the mixed allergen compositions to a subject. The mixed allergen compositions find use in a variety of applications, including health maintenance, immune balance, gut balance, immune support, health improvement and therapeutic applications.

Abstract: Summary Problem The purpose of the present invention is to provide: a chiral nucleic acid adjuvant having anti-tumor activity; and an anti-tumor agent. Solution The present invention relates to an adjuvant for anti-tumor agent, wherein the adjuvant comprises oligonucleotides which comprise two to four CpG motif each represented by 5?-X1CpGX2-3? and has a length of 14 to 32 nucleotides, wherein a nucleic acid at 3? end side of at least two CpG motifs is connected by phosphorothioate linkage, wherein each nucleic acid at 3? end and 5? end of the oligonucleotide is S type nucleic acid connected by phosphorothioate linkage, and wherein the oligonucleotide comprises at least one nucleic acid without phosphorothioate modification. The present invention relates to an anti-tumor agent containing its adjuvant.

Abstract: This invention related to manufactured microbubbles, as well as methods of using manufactured microbubbles, for example, in medicinal applications. The invention pertains to the physical structure and materials of the microbubbles, as well as to methods for manufacturing microbubbles, methods for targeting microbubbles for specific medicinal applications, and methods for delivering microbubbles in medical treatment.

Abstract: The invention relates to a combination comprising (i) a compound A comprising a mitochondrial targeting group linked to a group capable of releasing hydrogen sulfide or a pharmaceutically acceptable salt thereof or a prodrug thereof, an inhibitor of the thioredoxin antioxidant system or a pharmaceutically acceptable salt thereof or a prodrug thereof, and/or a nitroxide or a pharmaceutically acceptable salt thereof or a prodrug thereof; and (ii) a photosensitizer or photosensitizer precursor; for use in photodynamic therapy.

Abstract: The purpose of the present invention is to provide a pharmaceutical composition that comprises a specific compound and exhibits a superior preservation efficacy, the specific compound being stable within the pharmaceutical composition, and to provide methods for improving the stability of the specific compound within the pharmaceutical composition and the preservation efficacy of the pharmaceutical composition. The pharmaceutical composition according to the present invention comprises isopropyl (6-{[4-(pyrazol-1-yl)benzyl](pyridin-3-ylsulfonyl)aminomethyl}pyridin-2-ylamino)acetate or a salt thereof, and further comprises edetic acid or a salt thereof.

Abstract: An agent enhances the therapeutic or prophylactic effect of a renin-angiotensin system inhibitor on renal diseases, including a specific prostaglandin I derivative such as beraprost sodium as an effective ingredient.

Abstract: Personal care products are provided. An exemplary personal care product includes a composition that is applied to the body or clothing, or an article applied against the body; a plurality of particles associated with the composition or a component of the article, the plurality of particles, at least some of the plurality of particles comprising a cyclodextrin complexing material and a first fragrance material, wherein the percent of the first fragrance material that is complexed with the cyclodextrin is greater than about 90%, so that the perceptibility of the first fragrance is minimized prior to its release; and a second fragrance material that is not complexed with the cyclodextrin and that is different from the first fragrance material, wherein the composition or article does not contain an antiperspirant active.

Abstract: This pharmaceutical composition contains a hydroxamic acid derivative, or a salt thereof, and a solubilizer, said hydroxamic acid derivative being selected from among (2S)-2-((4-((4-((1S)-1,2-dihydroxyethyl)phenyl)ethynyl)benzoyl)(methyl)amino)-N-hydroxy-N?,2-dimethylmalonamide, 2S)-2-((4-((4-((1R)-1,2-dihydroxyethyl)phenyl)ethynyl)benzoyl)(methyl)amino)-N-hydroxy-N?,2-dimethylmalonamide, and (2S)-N-hydroxy-2-((4-((4-((1S)-1-hydroxy-2-methoxyethyl)phenyl)ethynyl)benzoyl)(methyl)amino)-N?,2-dimethylmalonamide. The pharmaceutical composition demonstrates strong antibacterial activity, has excellent solubility in water, and is useful as a drug.

Abstract: The invention provides a controlled release biodegradable polymer formulation adapted for administering bioactive agents, such as therapeutic proteins, to a patient through implantation of a bolus that forms a depot within the patient's body tissues. The formulation includes a dehydrated inclusion complex of the bioactive agent within a hydrogel. A method of forming the inventive formulation is also provided, as well as a method for using the formulation in the treatment of a malcondition in a patient in need thereof.

Abstract: The invention provides antibody-drug conjugates comprising an antibody conjugated to an anthracycline drug moiety via a disulfide linker, anthracycline disulfide intermediates, and methods of using the antibody-drug conjugates.

Abstract: Described are nucleic acid regulatory elements that are able to enhance liver-specific expression of genes, methods employing these regulatory elements and uses of these elements. Expression cassettes and vectors containing these nucleic acid regulatory elements are also disclosed. These are particularly useful for applications using gene therapy.

Abstract: A nectar type bird feeder having an incorporated short-wavelength, ultraviolet light source adapted to illuminate the nectar contents and feeder internal surfaces. The ultraviolet light exposure functioning to significantly retard the growth of nectar spoiling micro-organisms and thereby to significantly extend the nectar freshness or service life. The ultraviolet light source may be built directly into the nectar feeder or configured as an add-on accessory. The preferred embodiment of the nectar feeder, ultraviolet light device will be solar powered and made to cycle on/off automatically. As hummingbirds are adapted to see UV-A light (300 nm-400 nm) the light source may be cycled on/off during the day to make the feeder visually conspicuous and thereby more attractive to the feeding birds.

Abstract: A communication unit receives spraying target information indicating a spray target. A spraying target detector detects the spray target indicated in the spraying target information in space. A spray control unit is a unit that performs ion-spraying processing on the spray target at a predetermined frequency. In the ion-spraying processing, the spray control unit determines a moving direction of an ion spraying apparatus from a current location to the detected spray target, and sprays ions on the spray target when a distance between the spray target and the ion spraying apparatus is within a first threshold value. A flight control unit controls a flight of the ion spraying apparatus in the moving direction.

Abstract: A cartridge having a microfluidic die and a fluid composition in fluid communication with the microfluidic die is provided. The fluid composition includes from about 50% to about 100%, by weight of the fluid composition, of a perfume mixture, wherein the perfume mixture has a mol-weighted average C log P of less than or equal to about 2.9; a polyol; and from about 0.25 wt. % to about 9.5 wt. %, by weight of the fluid composition, of water.

Abstract: Medical constructs with twisted cables formed from a plurality of collagen fibers twisted together to form strands and those strands twisted together to form cables and relate methods of twisting the collagen fibers to form the medical constructs while holding the fibers and strands of fibers in tension and twisting in a first direction (i.e., in a clockwise direction), then twisting them in a second opposing (counterclockwise) direction for a number of twists per inch.

Abstract: The invention relates to a hardenable multi-part liquid acrylic composition. The composition comprises a storage stable liquid first part, a storage stable liquid second part and optionally, a third or further liquid parts. The parts are operable to form a cement which hardens to a solid upon mixing of the parts together. The composition comprises an acrylic monomer component, an initiator component, acrylic polymer particles and a radiopacifying filler. The initiator component is present in an amount of effective to polymerize the acrylic monomer component upon being mixed and/or activated therewith. At least some of the radiopacifying filler is encapsulated within and/or adsorbed on the acrylic polymer particles in a liquid part.

Abstract: The disclosure relates to an implant material for filling bone defects, for bone regeneration, and for bone tissue engineering, to an implant comprising this material, to a method for producing such an implant, and to a method for producing a hybrid material. The implant material comprises a hybrid material comprising: a bioactive glass M based on SiO2 and CaO, optionally containing P2O5 and/or optionally doped with strontium, and a biodegradable polymer P soluble in a solvent and chosen from among bioresorbable polysaccharides. The implant material has applications in the medical field.

Abstract: In alternative embodiments, the invention provides products (articles) of manufacture comprising nanostructures such as nanotubes having a surface comprising tantalum. In alternative embodiments, products of manufacture of the invention include nanostructures, e.g., nanotubes, nanowire, nanopore, and the like comprising a surface layer of tantalum. In alternative embodiments, products or articles of manufacture of the invention are bioimplants, and the tantalum-surface-coated nanostructures of the invention provide increased bioactivity and bone forming ability. In alternative embodiments, products or articles of manufacture of the invention, e.g., bioimplants, comprising the tantalum-surface-coated nanostructures of the invention are used for in vitro, ex vivo and in vivo testing, implants, biomedical devices and therapeutics.

Abstract: Disclosed is a patch system for use in a patient with a damaged heart. The patch comprises both a biodegradable engineered collagen scaffold to provide structural support to the injured heart and therapeutic agents, which are delivered by the patch to the heart. The scaffold consists of a dense collagen lamella produced by plastic compression with biomechanical properties that make it compatible with beating heart tissue, e.g. stiffness in a predefined range. One therapeutic agent, Fstl1, is shown to induce cardiomyocyte proliferation and enhance cardiac regeneration after injury. The patch can also be loaded with functionalized nanoparticles to yield multi-modal imaging capabilities in vivo. Also disclosed is a method for implanting the patch onto a patient's heart.

Abstract: Implants for osteo and osteochondral repair have been developed. These implants include a series of channels between the upper and lower surfaces of the implants, such that when implanted the lower surfaces are situated in an area rich in bone marrow and the channels provide a means for the bone marrow to migrate through the implant. Preferably the implants are made from resorbable polymer fibers, preferably arranged in braids that are knitted or woven together such that the braids are substantially parallel with each other. The implants may be rolled into a bundle of braids with the axis of the braids substantially parallel to the axis of the bundle, to provide channels along the axis of the bundle. A preferred embodiment includes P4HB fibers braided and knitted into a structure that is coated with a ceramic, preferably physiologic calcium phosphate.

Abstract: The present invention relates to a three-dimensional cell culture system which can be used to culture a variety of different cells (Human mesenchymal stem cells, Human fibroblast, Keratinocytes, fibroblast differentiated form mesenchymal stem cells in vitro and keratinocytes differentiated form mesenchymal stem cells in vitro) in vitro for continued periods of time. In the present invention, mesenchymal stem cells (MSCs) derived from bone marrow or umbilical cord are inoculated and grown on a pre-established scaffold or matrix made up of chitosan and gelatin. The developed tissue constructs contain cells, growth factors, cytokines and other regulatory factors secreted by cells. The developed bioengineered tissue constructs provide the support, growth factors and essential cytokines for wound healing. Developed tissue construct useful in the treatment of burns wound, diabetic foot ulcer wound and type of chronic skin wounds. It is helpful in healing and regeneration of skin tissue.

Abstract: A method of reducing the risk of embolization of peripheral blood vessels by providing a medical device having an expandable member having a drug coating layer which has a crystalline morphological form including a plurality of crystal particles of a water-insoluble drug regularly arranged and uniformly sized on the surface of the medical device, inserting the medical device in peripheral blood vessels, expanding the expandable member, pressing the drug coating layer to a blood vessel wall such that at least part of the plurality of crystal particles are transferred to the blood vessel wall, and deflating the expandable member such that the generation of microparticulates having a size that causes embolization of peripheral blood vessels is suppressed.

Abstract: The disclosure pertains to hemostatic compositions comprising a plurality of nonwoven fibers disposed in a rapidly soluble solid matrix and methods of making and using the same. The compositions may also comprise one or more therapeutic agents.

Abstract: In one aspect, the present invention relates to a wound care system. The wound care system includes a power unit and a processor coupled to the power unit. An ultra-violet light-emitting diode array is electrically coupled to the processor. A thermoelectric element is thermally exposed to the ultra-violet light-emitting diode array. A probe is optically coupled to the ultra-violet light-emitting diode array. The thermoelectric element cools the ultra-violet light emitting diode array thereby optimizing the ultra-violet light emitting diode array.

Abstract: Adjustable covers, systems, and methods are presented that include an adjustable cover that may be adjusted to an appropriate size by hand without requiring cutting tools and without substantial leaks. In one instance, the adjustable covering includes a drape member with a plurality of non-leaking tear paths. Each non-leaking tear path includes a weakened path of the drape member that may be torn. The adjustable covering may further include a first plurality of tear starters formed on a first initiation edge of the drape member. Each tear starter of the first plurality of tear starters is aligned with one of the plurality of tear paths. Each of the first plurality of tear starters is adapted to facilitate the initiation of a tear along a tear path. The grains of the drape member, a backing layer, and support layer may also be in the same direction. Other adjustable covers, systems, and methods are presented.

Abstract: A breastshield unit for use with a breastpump for expressing human breastmilk has a breastshield for receiving a mother's breast and a media separation device for transferring a vacuum into the interior of the breastshield. The breastshield has a receiving area for receiving a nipple of the mother's breast. The media separation device has a media separation membrane which, for the purpose of transferring the vacuum, is movable to and fro between two positions. The media separation membrane is located in the receiving area at least in one of the two positions. Despite the integrated media separation, the breastshield unit can be made extremely compact and minimizes the dead volume.

Abstract: A dressing system is disclosed which has a sponge and a near infrared spectroscopy sensor positioned adjacent to the sponge for monitoring oxygenation levels of tissue adjacent to the sponge. The dressing system may further include a tube coupled to the sponge for removing fluid from the sponge. The dressing system comprises: a sponge; and a tensioning system coupled to the sponge. The tensioning system further comprises a central longitudinal member coupled to the sponge; and at least one tensioning member coupled to the central longitudinal member. A sequential compression system comprises: an envelope sleeve dressing; and a bladder that is both expandable and retractable. A tissue filler system is also described and includes a plurality of tubes; wherein each of the plurality of tubes further comprises apertures; and a pump coupled to at least one of the tubes which obviates the need for any sponge or wound screen.

Abstract: Reduced-pressure medical dressings, systems, and methods involve a dressing with a first barrier layer that desolidifies when exposed to a fluid—typically a liquid—to form a treatment aperture in the first barrier that is used to deliver reduced pressure to a tissue site. The first barrier layer is formed from a desolidifying material. The system includes a drape covering a second surface of a manifold and a portion of the patient's epidermis to provide a substantially sealed space containing a manifold and the first barrier layer. Other systems, dressings, and methods are also disclosed.

Abstract: An impeller includes a hub and a blade supported by the hub. The impeller has a stored configuration in which the blade is compressed so that its distal end moves towards the hub, and a deployed configuration in which the blade extends away from the hub. The impeller may be part of a pump for pumping fluids, such as blood, and may include a cannula having a proximal portion with a fixed diameter, and a distal portion with an expandable diameter. The impeller may reside in the expandable portion of the cannula. The cannula may have a compressed diameter which allows it to be inserted percutaneously into a patient. Once at a desired location, the expandable portion of the cannula may be expanded and the impeller expanded to the deployed configuration. A flexible drive shaft may extend through the cannula for rotationally driving the impeller within the patient.

Abstract: Present embodiments are directed to measuring and calculating parameters to control and monitor a power transfer in an implanted medical device. The medical device may be implanted in a subject and typically includes an artificial heart or ventricle assist device. The system measures parameters and uses the parameters to calculate a coupling coefficient for coils that transfer power between an external primary and an implanted secondary. The system uses the calculated coupling coefficient to estimate heat flux being generated in the system. Based on the level heat flux detected, the system may issue alerts to warn the subject or control actions to mitigate the effects of the heat flux.

Abstract: A hemodynamic flow assist device includes a miniature pump, a basket-like cage enclosing and supporting the pump, and a motor to drive the pump. The device is implanted and retrieved in a minimally invasive manner via percutaneous access to a patient's artery. The device has a first, collapsed configuration to assist in implantation and a second, expanded configuration once deployed and active. The device is deployed within a patient's aorta and is secured in place via a self-expanding cage which engages the inner wall of the aorta. The device includes a helical screw pump with self-expanding blades. Also included is a retrieval device to remove the hemodynamic flow assist device once it is no longer needed by the patient. Also included is an arterial closure device to close the artery access point after implantation and removal of the hemodynamic flow assist device.

Abstract: A method for performing a medical procedure requiring effective, reliable and foolproof delivery of controlled amounts of a medical grade gas to a patient includes providing a compressed gas cylinder having a weight with medical grade gas sealed therein of at least twelve grams and not greater than fifty grams. The method also includes connecting the compressed gas cylinder to an integrated compressed gas unit including a regulator valve assembly positioned between an outlet port and an inlet port, wherein the regulator valve assembly includes a press button actuator and regulator adjustment dial. A flow control system is secured to the compressed gas unit and the medical grade gas is delivered in precisely controlled amounts by actuating the compressed gas unit and operating the flow control system to deliver the medical grade gas to vasculature of the patient.

Abstract: An operable implant adapted to be implanted in the body of a patient. The operable implant comprising an operation device and a body engaging portion, the operation device comprises an electrical motor comprising a static part comprising a plurality of coils and a movable part comprising a plurality of magnets, such that sequential energizing of said coils magnetically propels the magnets and thus propels the movable part. The operation device further comprises an enclosure adapted to hermetically enclose the coils of the static part, such that a seal is created between the static part and the propelled moving part with the included magnets, such that the coils of the static part are sealed from the bodily fluids, when implanted.

Abstract: An infusion adapter for connection with an infusion fluid container includes a connection portion including an anchor component for connecting to an injection port of the infusion fluid container, and a first port adapted for connection with a syringe assembly containing a medication fluid. The first port is in fluid communication with the connection portion. The anchor component is configured to securely connect the infusion adapter to the infusion fluid container to substantially prevent disconnection of the infusion adapter from the infusion fluid container once the infusion adapter is connected to the infusion fluid container.

Abstract: A method for delivering medication includes programming an operations processor of a medication delivery operations module to control the base function of medication delivery of a delivery device at a selectable rate and a selectable volume. An advanced medication delivery program is created by an advanced program processor that is part of an advanced interface module (“AIM”) located with the operations module in the same housing, although the processors are separate. When the advanced delivery program is complete and in a buffer, the operations processor executes the stored advanced delivery program under which the operations processor automatically varies at least one of the rate of delivery and volume of delivery values in accordance with the advanced delivery program autonomously without being under real time control of, or dependent on, any remote processor or data source, including the AIM. Support for PK applications is provided.