CALL FOR PAPERS

2012 AAPS Annual Meeting and Exposition October 1418, 2012

McCormick Place, Chicago

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DEA ISSIO D N May 9 LINE

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May 9, 201

Extension Services in Pharmacy School of Pharmacy University of Wisconsin-Madison

2012 Professional Development Programs for the Pharmaceutical Industry http://ce.pharmacy.wisc.edu

Extension Services in Pharmacy is your source for the best in professional development with a reputation for programs providing compelling science, topic experts and networking opportunities.

Land OLakes Conferences

(Merrimac, Wisconsin)
The theme/topics of each of the four Land OLakes Conferences are designed to be relevant to a wide variety of industry groups with expert faculty from industry, academia and regulatory agencies presenting the latest information, trends and developments. June 11-15 July 16-20 August 6-10 Sept 10-14 54th Annual Pharmaceutical Research and Development Conference - The Formulation/Analytical Interface in Drug Development: Partnering for Success 13th Annual Bioanalytical Conference - Emerging Technology for Bioanalysis in the Next Decade 52nd Annual Pharmaceutical Analysis Conference - Extending the Boundaries of Pharmaceutical Analysis 15th Annual Drug Metabolism/Applied Pharmacokinetics Conference - Small Molecules vs. Biologics: Challenges in Drug Discovery & Development

Applied Drug Development Courses

(Madison, Wisconsin)
April 16-19 Principles and Experimental Strategies in Physiochemical Characterization, Solubilization and Solid Form Screening for Candidate Selection Practical Strategies for Developing Preclinical and Phase 1 Oral Drug Formulation CMC Project Team Management The Science and Principles and Practices for Successful Technical Leadership

May Madison Short Courses

(Madison, Wisconsin)
Including, but not limited to: Pharmacokinetics and Pharmacodynamics Principles of Solid Dosage Forms Stabilization of Pharmaceuticals for Preformulation and Drug Product Development Introduction to Drug Metabolism and Transporters Regulatory Issues in Drug Development Check our website for more details, dates, and additional courses

June 25-29 October 8-11

On-site Professional Development

(your company location)
Extension Services in Pharmacy offers on-site short courses designed for small groups and intended to provide practical information for individuals working in the pharmaceutical industry. Over 35 one-to-four day offerings are available and others can be developed to meet specific company needs.

New for 2012: Pharmaceutical Engineering and Technology Series

Pharmaceutical Laboratory Controls for FDA Compliance Quality by Design (QbD) in Pharmaceuticals Manufacturing

April 16-17, 2012 Metropolitan Philadelphia Area

Join our Linkedin group: University of Wisconsin Extension Services in Pharmacy Industrial Professional Development
Extension Services in Pharmacy School of Pharmacy University of Wisconsin-Madison Toll free: 877-947-4255 Email: cemail@pharmacy.wisc.edu

For program updates and to see other programs offered by Extension Services in Pharmacy, visit our website

http://ce.pharmacy.wisc.edu

FROM THE PRESIDENT

Dear Colleagues and Friends:

On behalf of the AAPS Annual Meeting Program Committee, it is my pleasure to officially announce the Call for Papers for the 2012 AAPS Annual Meeting and Exposition. You are invited to join us October 1418 at McCormick Place in Chicago. With an expected attendance of almost 9,000 and representation from dozens of countries, the AAPS Annual Meeting and Exposition is a prime opportunity for you to showcase your research; network with other scientists performing similar work; and contact potential employers and clients. Whether you are planning to participate in the AAPS Annual Meeting and Exposition for the first time, or you will be attending it again, you are encouraged to submit an abstract of your work for presentation in Chicago. Abstract submissions can be completed online at www.aaps.org/2012submit. Enclosed are detailed instructions for the abstract submission process. The online abstract submission deadline is May 9, 2012. We look forward to your participation in the 2012 AAPS Annual Meeting and Exposition. The preliminary program and registration information will be available online in June on the AAPS Website. If you have any questions, please contact the AAPS Office, 2107 Wilson Boulevard, Suite 700, Arlington, Virginia, 22201-3042, USA; phone: +1 703.243.2800; fax: +1 703.243.5582; or via email at aaps@aaps.org. I look forward to seeing you in Chicago. Sincerely,

David Mitchell, Ph.D. AAPS PRESIDENT

2012 AAPS Annual Meeting and Exposition

NOW OPEN
CONTRIBUTED PAPER SUBMISSION SITE
Submit your Contributed Paper at www.aaps.org/2012submit

Travelships
Application Deadline: June 25, 2012
AAPS Annual Meeting and Exposition will be offering a number of travelships for its meeting held on October 1418, 2012 in Chicago. Travelships will be awarded to those who submit and have an abstract accepted to the AAPS Annual Meeting and Exposition. To submit a paper, visit www.aaps.org/2012submit. Please visit http://www.aaps.org/ awards-and-fellows for additional eligibility requirements.

Submission Deadline: May 9, 2012

IM P ORTANT DATE S TO R E M E M B E R
Submission Deadline May 9 Notification of Acceptance/Rejection June 8 Deadline to Appeal Rejection June 14 Deadline to Submit Provisionally Accepted Abstract June 14 Notification of Appeals June 15 Presenting Author Registration Deadline September 7 Notification of Presentation Schedule/ Poster Number September 11
PLEASE DO NOT CONTACT AAPS TO RECEIVE A DEADLINE EXTENSION. DEADLINE EXTENSIONS CANNOT BE GRANTED UNDER ANY CIRCUMSTANCE!

NEW
VERY IMPORTANT INFORMATION
REGISTRATION REQUIREMENT = Register by September 7, 2012 NOT REGISTERED BY SEPTEMBER 7, 2012 = abstract will not be published or scheduled to present WHEN REGISTERING = provide abstract submission ID for each poster AUTHOR CHANGES = submit to abstracts@aaps.org by September 7, 2012

Submission Requirements
The following requirements must be adhered to when submitting your abstract for AAPS meetings. AAPS has implemented these policies in response to feedback from meeting participants. The most overwhelming source of dissatisfaction with past meetings has been the number of presenters who fail to show up for their presentation.
1. Conditions and Policies Persons submitting an abstract for presentation at the AAPS Annual Meeting and Exposition are doing so with the understanding that they agree to abide by the conditions and policies provided below, as well as the decisions of the Screening Committee and AAPS staff. Questions should be directed to abstracts@aaps.org. 2. Registration Requirement for Publication The presenting author is required to attend the meeting to present the paper. If the presenting author is unable to attend the meeting the co-author is responsible for the presentation. Registration is required for the author that will be presenting the paper at the meeting and the author must be registered by the Presenting Author registration deadline of September 7, 2012 or the poster will automatically be withdrawn. Withdrawn posters will not be published on the AAPS portal via Pharmaceutical Research or The AAPS Journal. If the author is working in an exhibitors booth, the authors exhibitor badge will suffice for this registration requirement. 3. Cancellation policy If the presenting author cancels his/her registration on or after September 8, 2012, AAPS will impose a $200 ($50 student) publishing fee. Registrant substitutions from the same company are allowed and may be submitted in writing at any time without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge may apply. 4. Ethics Statement Final poster presentations must include the accepted abstract verbatim and should include all methods used and data resulting from the research. Actions such as omission of data from a poster presentation that was included in the submitted abstract will be considered unethical. Authors and organizations violating these requirements will be subject to penalties such as restrictions from presenting future posters.

NOTE: We are unable to accept requests to change the presentation schedule once the abstracts have been assigned. Therefore requests to change the day, time or location of your assigned presentation will not be granted. If the presenting author is unable to attend the meeting another author will be responsible for the presentation.

CALL FOR PAPERS

ABSTRACTS
Policies and Procedures
The submission system can be accessed at www.aaps.org/2012submit. If you are unable to use all the features of the site, contact your system administrator and request your system to allow cookies.
Safe Email Address/Contacts
Before beginning the abstract submission process, add abstracts@aaps.org to your email address/contacts list.

Screening/Presentation
Final assignment to poster sessions will be made at the discretion of the screening committee.

Permissions/Clearances
It is the responsibility of the author(s) to obtain the necessary permissions and clearances for all research prior to submission of the abstract. AAPS assumes no liability or responsibility for the publication of any material that is submitted.

Notification of Acceptance/Rejection
Status notifications will be sent via email on June 8, 2012. Notification and other correspondence will be sent to the abstract submitter, main author and presenting author. If there is a change in presenting author after the final submission deadline, contact AAPS at abstracts@aaps.org.

Acceptance Criteria
Acceptance of the abstract for presentation will be based on the concise, accurate presentation of new data. It is imperative that data is presented in the results section so the AAPS screeners can judge the scientific value of your abstract. Include all research information, data, charts and graphs in your submission so that it can be reviewed in its entirety. All papers will be scheduled by the Screening Committee.

Provisional Acceptance
A provisional acceptance is granted to an abstract that is acceptable for presentation, but does not adhere to the formatting guidelines set forth in the Call for Papers. The author is given the opportunity to correct the formatting, spelling, grammar, or symbols. Revisions are required within 5 days of receipt of the notification. Deadline for receipt of revised abstracts is June 14, 2012. If AAPS has not received the revised abstract by this date, the abstract will automatically be rejected. The Appeals Process does not apply to provisionally acceptance abstracts.

Rejection Criteria
Criteria for rejection include lack of data, commerciality, inconsistent or ambiguous data, reviews of literature, lack of novelty or innovation, stating that information will be included in the poster, previously published, but not acknowledged (see Encore Presentation), or failure to follow format guidelines (Purpose, Methods, Results, and Conclusion). The submission of multiple abstracts covering the same or similar work is discouraged. Authors must submit one strong abstract instead of several abstracts presenting the same work.

Abstract Appeals Process

If your abstract has been rejected and you would like to challenge the decision, please proceed as follows: 1. All appeals must be communicated to AAPS at appeal@aaps.org within three business days of notification. Appeals will be sent on to the Screening Chair of your section. Deadline for receipt of all appeals is June 14, 2012. Appeals received after that time will not be forwarded to the Screening Chairs. 2. The Screening Chair will review the abstract and make the decision to uphold or reverse the rejection. All appeals will be adjudicated by June 15, 2012. 3. No revisions or modifications to abstracts will be allowed. The work will be reviewed as it was originally submitted. Authors may not supply additional data. You must follow these steps in order to appeal your abstract rejection. Do not go directly to the Section Chair, as s/he will refer you back to AAPS staff.

Abstract Revisions
Revisions can be made at any time before the submission deadline. Proofread, spell-check and make sure all authors are listed on your abstract before submitting as the abstracts will be printed exactly as they appear when submitted. If you revise your submission you must repeat all submission steps. Failure to complete all the steps will result in an incomplete submission and your abstract will not be sent to the Screening Committee. Revisions cannot be made after the submission deadline of May 9, 2012. Please do not contact AAPS to receive a deadline extension. Deadline extensions cannot be granted under any circumstance.

Notification of Receipt and Verification of Submission

You will receive immediate confirmation of completion if you have successfully submitted the abstract. This notification only confirms receipt of your submission and is not a notification of acceptance. If you do not receive immediate email confirmation then your submission is not complete. You will need to log back onto the submission website to complete the submission process. (See Abstract Revisions above.)

Notification of Presentation Schedule and Poster Number

Notifications will be sent via email by September 11, 2012 with the presentation date, time and Poster Number for the abstract. If you do not receive notification at that time, please contact AAPS at abstracts@aaps.org for an update on the schedule of your abstract. Notifications will be sent to the abstract submitter, main author, and presenting author.

Encore Presentations
You are invited to submit papers that were presented at a nonAAPS meeting after March 1, 2012. Please indicate the following with your submission: 1. Indicate the submission is an Encore Presentation. 2. The name of the meeting at which the paper was originally presented. 3. Indicate the date the paper was originally presented. No papers presented before March 1, 2012 will be accepted as Encore Presentations. Encore Presentation submissions will be screened under the same criteria as other contributed papers.

Abstract Withdrawal
To withdraw your abstract, written notification must be sent to abstracts@aaps.org. You may withdraw your poster at anytime, however due to publishing deadlines, withdrawal notifications must be received by September 7, 2012 to ensure withdrawal from online publication and the final program. This notification must be from the submitter of the abstract and should include the abstract title, authors, the abstract confirmation number, and the name, phone number and email of the person making the request. AAPS will acknowledge all withdrawal notifications by email.

2012 AAPS Annual Meeting and Exposition

ABSTRACTS
Submission Instructions
The submission system can be accessed at www.aaps.org/2012submit. Create a user account by either selecting New User or Create New User with AAPS Member ID. Non-members should click on the New User link. Enter the information requested on the Login Information page. Then click Enter, your login and password will be sent to the email address you provided. AAPS members should click on the Create New User with AAPS Member ID link. Next, a prompt will appear asking for the membership identification number. Once this is supplied, all of the necessary contact information is automatically entered. If you do not know your membership identification number, contact AAPS at +1.877.998.2277 for assistance.

Six Steps to the Successful Submission of Abstracts

1 2 3

(Note: Do not use ALL CAPS at any time during the submission process.) COPYRIGHT: Read and acknowledge the Copyright.

AUTHORS: When adding your authors you must designate a Presenting Author and a Main Author. All correspondence will be sent to the submitter, main author and presenting author you will need these email addresses for submission of your abstract. One author can be designated as both the main author and the presenting author. The authors can be in any order you designate and the arrows in the Promote/Demote columns allow the order to be rearranged. Enter first names only in the First Name Box. Enter your full middle name in the Middle Name Box. Enter last name or family name in the Last Name Box. If your last name is hyphenated, include the hyphen between the two names. Enter any middle or secondary name(s) in the Middle Name Box. It is important to use these boxes correctly or your author name(s) will not appear in the correct order for the List of Authors in the Final Program. When finished, click on the Finished Adding Authors link. This is the only place you enter your author information. ABSTRACT: We have made changes in the submission process. You can no longer upload a word document. You must copy and paste your text from a word document into the text boxes for Purpose, Methods, Results, and Conclusion. Do not include the headings Purpose, Methods, Results, and Conclusion in your copied text for the text boxes.

4. Upload Graphics your graphics must be in jpg or gif file formats and will automatically be resized to the submission site specifications. Images will appear with a maximum height of 200 pixels. The width of the image will depend on how many images you upload. You may upload no more than three (3) graphic files for your abstract. Include a caption for the graphic as part of the image (example: Table 1 or Image 2). Once you have uploaded your image(s)/graphic(s), click on the Finished Adding Images button. Make sure your graphic is legible during the Proofing Stage. 5. Select Preview to proof your abstract. Carefully review the proof for format, spelling, grammar, and special characters. Close the preview window and make edits if necessary. Once satisfied the abstract is complete, select Continue.

4 5 6

ABSTRACT DETAILS: Select the Primary Topic from the pull-down menu. From Subtopic section pull down menu make the selection that is most relevant to your submission. The pull down menu for the Sub-topic is only available for the Primary Topic you have selected.

Primary Topic Subtopic Secondary Topic*

*ALL PRIMARY TOPICS WILL HAVE A SUBTOPIC, HOWEVER NOT ALL SUBTOPICS WILL HAVE A SECONDARY TOPIC. IF A SUBTOPIC DOES NOT HAVE A SECONDARY TOPIC, THEN PROCEED TO THE NEXT STEP. A FULL LIST OF PAPER TOPICS IS ON PAGES 89.

Answer the Are you a Student question. If you are a student, you will be asked to supply the name and email address of your Primary/ Principal Investigator. PROOFREAD: Click Proofread button to review your submission to confirm that it is complete. If satisfied, close the proofread box and select Accept My Abstract. If you want to make changes, select Resubmit My Abstract. If you do not want to choose either of these options you can log off and return later. In the upper left hand corner there is a link to Logoff. Proofread your abstract before you accept it. No changes can be made after the submission deadline of May 9, 2012.

If you include graphics or tables in your abstract, the images must be in jpg or gif file format. A limit of three (3) images may be uploaded for your abstract. Image labels or captions such as Table 1 or Image 1 should be included in the image file. 1. Fill in the Title Do not use ALL CAPS in the title or any portion of the abstract. This is the only place you enter your title. 2. Fill in the Purpose, Methods, Results, and Conclusions. There is a 350 word limit, excluding the title and authors, so you will need to defer to the counts at the bottom of this screen. Do not include the headings in your copied text for each box. 3. Special Characters if your abstract contains symbols or special characters, please make sure they are converted correctly during the proofing stage. The table on the right shows the available symbols/characters. If these do not convert into the pdf properly, go back to the text boxes and use the table by clicking on the symbol while your cursor is in the appropriate place within the text. This will insert html code for the symbol. Once you have completed this, proof your abstract again.

SUBMIT YOUR PAPER: You must click Accept My Abstract in order to successfully complete the submission process.

Technical Help
If you have any questions or are experiencing difficulties in the submission process, contact AAPS at abstracts@aaps.org. NOTE: Do not send abstracts directly to the screeners. Abstracts must be submitted according to the Call for Papers.

CALL FOR PAPERS

Acceptance Criteria for Regulatory Sciences (RS) Abstracts

The RS section encourages AAPS members to submit an abstract of research or position paper. The position paper is a manuscript of a viewpoint, suggestion, or philosophy, borne by the authors, on a current regulatory issue of interest facing the pharmaceutical industry and/or the regulatory agency. The abstract of this position paper may provide conclusive summary, recommendation, or it may provide proposals for future discussion. Alternatively, the standard AAPS formats for research abstracts may also be used. Example Abstract for Regulatory Sciences Section: The headings in the (parentheses) are proposed for use for RS position paper abstracts only, followed by explanations as aid to authors. (Note: This is provided as an example only, and does not constitute any position by the industry, agency or any other stakeholders.)
TITLE: Brief description of issue or position. the arguments. Present the pros (or cons), extrapolations, and intrapolations in thinking both from the agencys and the industrys viewpoints (both consumers or stakeholders). The law and regulations are currently not in place to make the requirement of pharmaceutical development data to be mandatory. Currently, many companies provide an overview of the pharmaceutical development studies performed during the development process in the NDA to justify process parameters and specifications. The depth of the information needed to substantiate availability of data will lead to a transparent drug development process that can result in loss of proprietary information. On the other hand agency will have an increased understanding of the formulation leading to interpretation that some changes previously considered major may be considered minor with the availability of data in the application. CONCLUSION: (Recommendations) Summarize arguments or proposals for future discussions. Summarize key recommendations or arguments that might address the issue. The current approach by the agency to keep the inclusion of the pharmaceutical development data optional might be beneficial as it gives an opportunity to industry to evaluate if providing the data is truly a blessing and reduces the regulatory reporting requirements or is it a burden that requires extensive data collection that may or may not result in a reduction in regulatory reporting requirements.

Pharmaceutical Development Data in New Drug Applications: A Blessing or a Burden?

AUTHORS: Jane Doe, John Joe, et al. PURPOSE: (Scope) Provide the scope of the issue, what is and why is it an issue? What is the historical background of the issue, and what are the impacts to the regulatory environment? The GMP initiative for the 21st century was initiated in Aug 2002 by FDA to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. Part of the GMP initiatives for the 21st century by FDA include incentives to the industry which proposes submission of extensive pharmaceutical development data in NDA could lead to a reduction in reporting requirements for post-approval supplements resulting in a reduction in regulatory burden for the stakeholders. METHODS: (Approach). Provide method of analysis or approach in reviewing of the law, applicable regulations, guidelines, and FDA Compliance Policy Guides (CPGs), or other applicable references. FD&C Act section 505 (b) (1) provides the applicable law for the information to be provided in the new drug application. 21 CFR 314.50 (d) (1)(ii) provides the applicable regulations for content of a drug product section. The regulations mirror the law in requiring information related to composition, manufacturing and controls of the commercial product. RESULTS: (Arguments) Provide the basis and substantiate

Sample Abstract COMPLIMENTS OF APQ SECTION

Quantitative Determination of Compound X in Rat and Dog Plasma Using LC/MS/MS
PURPOSE: To develop and validate an LC/MS/MS method for the determination of compound X, an anti-cancer agent in rat and dog plasma. METHODS: This method utilized a solid phase extraction from 0.1 mL plasma with an Isolute C2 cartridge and methanol as eluent. HPLC separation was carried out on a Phenomenex Luna C18 column (150 x 4.6 mm) column at a flow rate of 0.3 mL/min with an analysis time of 4.5 minutes. Compounds were eluted using a mobile phase of H20/CH3CN/HCOOH: 70/30/0.1 (v/v/v), pH 4.0. Compound Y, a structural analogue of compound X was used as the internal standard to account for differences due to adsorption, extraction, and instrumental performance. Mass spectrometry detection was carried out with a PE Sciex API III+ triple quadrupole mass spectrometer equipped with a Turbo IonSpray as LC/MS interface. ESI mass spectra were acquired in positive ion mode with multiple reaction monitoring. RESULTS: No matrix interference was observed across the elution windows of X and Y, indicating the specificity of the method. Acceptable intraday and interday assay precision (<5% CV) and accuracy (<10% diff.) were observed over a linear range of 1-1500 nM for both matrices. The mean (n=3) correlation coefficients in rat and dog plasma were 0.99980.0001 and 0.99970.0002, respectively. The mean extraction recovery was 91.22.5% and 90.14.6% for rat and dog plasma, respectively. CONCLUSIONS: A validated method which was robust, sensitive, specific, accurate, and reliable was developed. The method has been used to quantify rat and dog plasma for pharmacokinetic and drug safety studies.

2012 AAPS Annual Meeting and Exposition

CONTRIBUTED PAPERS TOPICS

PRIMARY TOPIC SUBTOPIC SECONDARY TOPIC PRIMARY TOPIC SUBTOPIC SECONDARY TOPIC

DRUG DESIGN AND DISCOVERY

Chemical Biology and Highthroughput Screening Combinatorial Synthesis Computational Chemistry Drug Development for Specific Targets/Receptors Drug Discovery High Throughput Screening Molecular Diversity Natural Products Peptides, Oligonucleotides, Haptens Rational Drug Design Structure Activity Relationships Other

Oral, Controlled Release DRUG DELIVERY PHARMACEUTICAL TECHNOLOGIES (SMALL MOLECULE) Oral, Immediate Release cont...

Parenteral

Discovery Formulation Manufacturing Discovery Formulation Manufacturing Discovery Formulation Manufacturing

Physical Pharmacy Process Analytical Technologies Process Scale-up QbD in Formulation Design Solubility Enhancement Stability Programs Transdermal

In Vivo-In Vitro Relationships/CorDRUG DELIVERY BIOPHARMACEUTICS relations (see In Vitro Methods) Large Molecule Controlled Release Strategies Devices Mechanism-based Drug Design Nasal and Pulmonary Other Parenteral Targeted Drug Delivery & Prodrugs Transdermal Devices Mechanism-based Drug Design Nasal and Pulmonary Oral Other Parenteral Targeted Drug Delivery & Prodrugs Transdermal Active Passive

Formulation Manufacturing Discovery Formulation Discovery Formulation Manufacturing Discovery Formulation Manufacturing

Other

Small Molecule

LARGE MOLECULE PRODUCT DEVELOPMENT STRATEGIES

Biochemical Assay Related Issues (see Primary Topic: Analytical Methodology) Cell-based Therapeutic Mechanisms/Actions Effects of Fermentation, Cell Culture, Recovery, etc. Formulation

Apoptosis and Signal Transduction Growth Factors and Cytokines Transporter/Receptor Regulation

Transmembrane Permeability Issues Transporters (related to Drug Delivery) Other Aerosols DRUG DELIVERY PHARMACEUTICAL TECHNOLOGIES (SMALL MOLECULE)

Novel Therapeutics

Dermal/Topical

Devices

Liquids and Semisolids

Nanotechnology

Nasal and Pulmonary

Discovery Formulation Manufacturing Discovery Formulation Manufacturing Discovery Formulation Manufacturing Discovery Formulation Manufacturing Discovery Formulation Manufacturing Discovery Formulation Manufacturing

Characterization Design and Manufacture QC Issues and Design Space Stability Artificial Chromosomes Gene Therapy Non-viral NRNA Oligos Stem Cells Viral Virus-like Particles

Physical Pharmacy Vaccines Other

ANALYTICAL METHODOLOGY

Biomarkers Cell-based Assay

Chromatographic Approaches Immunochemistry Approaches Activity Assessment Immunogenicity Other In Vivo-In Vitro Relationships/ Correlations Method Development and Validation

Chiral Analysis Dissolution Technologies

Electrophoresis, Electrochromatography High-throughput Analysis

CALL FOR PAPERS

PRIMARY TOPIC

SUBTOPIC

SECONDARY TOPIC

PRIMARY TOPIC

SUBTOPIC

SECONDARY TOPIC

ANALYTICAL METHODOLOGY cont...

HPLC (Large Molecule) HPLC (Small Molecule) Hyphenated Methods Large Molecule (e.g., GC-MC,LC-MS, etc.) Hyphenated Methods Small Molecule (e.g., GC-MC, LC-MS, etc.) Immunoassay

Biological Matrix Non-biological Matrix Biological Matrix Non-biological Matrix Biological Matrix Non-biological Matrix Biological Matrix Non-biological Matrix Emerging Technologies Immunogenicity PK Samples

CLINICAL PHARMACOLOGY AND TRANSLATIONAL RESEARCH cont...

Theoretical and Statistical Aspects of Method Validation Microdialysis Methods Proteomics-protein Chip Ligand Binding Assays Sample Preparation Strategies Biological Matrix Non-biological Matrix Spectroscopic Techniques Biological Matrix Non-biological Matrix Stability Programs Other Biological Matrix Non-biological Matrix

Pharmacoeconomics Outcomes Research Pharmacokinetics (see Primary Topic Pharmacokinetics/ Pharmacodynamics) Pharmacotherapy Population Kinetics (see Primary Topic Pharmacokinetics/ Pharmacodynamics) Special Patient Populations Elderly Hepatic Other Pediatrics Renal Therapeutic Drug Monitoring Other Identification and Diagnostics Measurement Role in Clinical Pharmacology and Translational Research Translational Research Other

BIOMARKERS

Chromatographic Approaches Immunochemistry Approaches

PHARMACOKINETICS/ PHARMACODYNAMICS

Bioavailability

First Pass Effects/Drug Absorption Food Effects Formulation Effects Preclinical Clinical In Vitro Preclinical Clinical In Vitro Preclinical Clinical Trial Simulation DNA Microarray/Gene Chips Methodologies Modeling and Predictions Pharmacogenetics and Polymorphism (SNPs)

MANUFACTURING Clinical Supply

Process API Kilo Lab and Scale-up Cleaning Validation Contract Manufacturing Quality by Design Scale-up and Optimization Technology Transfer Computer Validation Change Control Contract Manufacturing Drug Shipment Materials Management and Warehousing Plant Equipment and Design Pre-approval Inspections Supply Chain

Clinical Drug Interactions

Drug Metabolism

Quality Systems

PK and PK/PD Modeling Population Studies

Other

Preclinical Tissue Distribution and Microdialysis Toxicokinetics/Toxicology Transporters

REGULATORY AFFAIRS

Clinical In Vitro Preclinical

Other

CLINICAL PHARMACOLOGY AND TRANSLATIONAL RESEARCH

Biomarkers (see Primary Topic Biomarkers) Clinical Trials

Adverse Events Biostatistics Clinical Data Management Conduct Drug Interactions Management Regulatory Issues

Biosimilars cGMP Chemistry, Manufacturing and Control (CMC) Clinical Trial CTD Dossier Environmental Concerns ICH Inspections Intellectual Property Marketing Pharmacovigilance Regulations/Guidance Safety/Efficacy Specifications Stability and Shelf-life Other

OTHER
2012 AAPS Annual Meeting and Exposition

FAQs
Q: How do I submit author names?
A: See Step 2 of Six Steps to the Successful Submission of Abstracts. To avoid errors be consistent with author names, i.e., John J. Doe; not John Doe, John J. Doe and J.J. Doe.

Q: Does AAPS provide grants or scholarships for student authors presenting a poster at the meeting?
A: No. However student authors may apply for a Travelship or for a Graduate Student Symposium award. Details regarding travelships and awards can be found on the annual meeting website at www.aaps.org/inside/awards_fellows.

Q: Do I have to be a member of the AAPS to submit an abstract?

A: No. Membership is not required.

Q: How can I make changes to my abstract?

A: Use your login/password to log back onto the submission website to make the necessary edits. You will need to go through all the submission steps again to receive a Successfully Submitted email. No changes can be made after the submission deadline of May 9, 2012.

Q: Can a paper previously presented be submitted?

A: Encore presentations abstracts that will be presented at a non-AAPS meeting after March 1, 2012 are acceptable submissions so long as the required notation is included in the abstract.

Q: What are the size constraints for an abstract?

A: The size of the abstract is limited to 350 words and must fit within a 9" x 7" page. The submission system will not allow a file larger than this size to be submitted.

Q: Who owns the copyright on the abstract and presentation?

A: Submission of an Abstract to AAPS assigns all right, title and interest, including copyright, to the association. If the abstract is accepted for poster presentation at the conference, I give AAPS permission to display the abstract on the AAPS website (www.aaps.org) and to publish in a future supplement of the AAPS Journal. All authors are aware that their names appear on the abstract. The author(s), however, reserve the following rights: All proprietary rights other than copyrights, such as patent rights; The right to use all or part of this abstract, including tables and figures in future works of their own, provided that the proper acknowledgment is made to the Publisher as copyright holder; The right to make copies of this abstract for his/her own use, but not for sale.

Q: If I am accepted as a poster presenter, do I need to register for the meeting?

A: Yes, all poster presenters must register for the meeting and pay all regular conference fees by the Presenting Author Registration Deadline of September 7, 2012.

Q: What happens if the presenting author is not registered by the presenting author registration deadline.
A: All abstracts, where the presenting author is not registered by September 7, 2012, will be automatically withdrawn from scheduling and will not be published.

Q: Is a presentation at AAPS a publication or a presentation at the meeting?

A: A presentation at an AAPS meeting can be considered both a publication and a presentation.

2012 Contributed Papers Screening Committee

CHAIR APQ SECTION DDD SECTION PPDM SECTION

Colin M. Minchom, Ph.D.

Cordack Inc. Pharmaceutical Consulting
CHAIR-ELECT

Krzysztof Selinger, Ph.D.

Forest Laboratories, Inc.
BIOTEC SECTION

Linyi (Kevin) Wei, Ph.D.

SAIC-F, National Cancer Institute at Frederick
FDD SECTION

Pankaj B. Desai, Ph.D.

University of Cincinnati
RS SECTION

Chris McCurdy, Ph.D.

University of Mississippi
PAST CHAIR

Shalini Gupta, Ph.D.

Amgen Inc.
CPTR SECTION

Jayachandra B. Ramapuram
Auburn University
MSE SECTION

Pramod Kotwal, Ph.D.

Merck & Co., Inc.
EXECUTIVE COUNCIL LIAISON

Tony DeStefano, Ph.D.

U.S. Pharmacopeia

Clinton F. Stewart, Pharm.D.

St. Jude Childrens Research Hospital
CPTR SECTION

Raman M. Iyer
Hoffmann-La Roche, Inc.
MSE SECTION

Russell Weiner, Ph.D.

Merck Research Laboratories
STAFF LIAISONS

Robert Bies, Pharm.D., Ph.D.

Indiana University

Ashlesh K. Sheth, Ph.D.

Merck & Co., Inc.
PPB SECTION

Sharon R. Pichon
AAPS

Teresa Homrich
abstracts@aaps.org Abstract Manager, AAPS 2107 Wilson Boulevard, Suite 700 Arlington, VA 22201 PH: +1.703.248.4792 FX: +1.703.243.5582

Weiguo Dai, Ph.D.

Johnson and Johnson

10

CALL FOR PAPERS