TRENDS OF MASS-ACTION LAW BASED THEORY COMPUSYN SOFTWARE, COMBOSYN, INC. PD SCIENCE LLC (USA)

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1 TRENDS OF MASS-ACTION LAW BASED THEORY COMPUSYN SOFTWARE, COMBOSYN, INC. PD SCIENCE LLC (USA) The Mass-Action Law Based Theory & Theorems Digital Pharmacodynamics/ Biodynamics: Definitions & Applications Synergism Digital Definition & Quantification Algorithms/Computerized Auto-Simulation Small Size Design & Experimentation Definitive/Quantitative Biology Econo-Green Bio-Medical R & D Scientific Definitions and Claims for Regulatory Affairs Ting-Chao Chou, July 25, 2017

2 [News Release, March 16, 2016] Chou & Talalay Paper from 1984 Makes History One of the most cited papers Published in 1984, the manuscript Quantitative analysis of dose-effect relationships: the combined effects of multiple drugs or enzyme inhibitors by Ting-Chao Chou and Paul Talalay has become one of most cited articles in all fields. With 3,520 citations, it is not only the most cited article in Advances in Biological Regulation, but also one of the most cited articles (being in the top 1% of most cited articles) in the field of Biochemistry, Cancer Research, Molecular Biology and Genetics (Scopus, 16 th March 2016). Here is what Ting-Chao Chou, first author of the manuscript tells us: Over 31 years ago, Prof. George Weber of Indiana University invited Prof. Paul Talalay (JHU) and me (MSKCC) to give a symposium talk sponsored by Eli Lilly, in conjunction with Advances in Enzyme Regulation. My talk was very much impressed by Professor Carl F. Cori of Harvard (Nobel Laureate of Medicine 1947). His vision has proven to be extremely insightful and accurate. The paper in Adv. Enz. Regul. 22:27-55, 1984 by Chou & Talalay has become among the most cited and the most broadly cited theoretical papers of all time in all fields. It is our pleasure to celebrate this milestone for our journal and for this occasion we have provided free promotional access to the article for 6 months on ScienceDirect.

3 Quantitative-Analysis of Dose-Effect Relationships- The Combined Effects of Multiple-Drugs or Enzyme-Inhibitors [The Combination Index Theorem] (As of ] CHOU, TC & TALALAY, P ADVANCES IN ENZYME REGULATION, 22: 27-55, 1984* Times Cited: 5,235; (4,112 Citations in 778 Journals) *Elsevier News Release: Chou & Talalay Article from 1984 Makes History ( )

4 4,112 Chou -Talalay CI Theory (1984)

5 Synergy Definition for Drug Combinations (Controversy for Over 100 Years) Drug Combination: Widely Used in Cancer, AIDS & Chinese Medicine Synergism: 20 Different Synergy Definitions None Supports the Others!! [A total mess in Basic Research, in Clinical Drug Combination trials (in Protocol Design & in Data Analysis) and in Governmental Regulations] Combination Index Theorem: Chou and Talalay, Equation & Algorithm CI <1, Synergism CI=1, Additive CI>1, Antagonism With Quantitative, Automated, Computerized Simulation Challenge: If No Clear Definition for Synergy: NIH, FDA, USPTO and Peer Reviewers have No Basis to Judge or to Regulate the Synergy Claims The Dispel of the Century-Old Controversy Chou TC Theory: Pharmacol. Rev. 58: , 2006 ( Review, 61-pages) (Cited 2,115 times by 538 journals) Adv. Enz. Regul. 22:27-55, 1984 (Created the CI theorem) (Cited 5,235 times by 778 journals) Cancer Res. 70: , 2010 (Perspectives) (Cited 1,453 times in 351 journals) 5

6 Ting-Chao Chou Google Scholar Citations [July 25, 2017]

7 Trends of Drug Combination Methods for Synergy Determination, June 2017* Thomson Reuters Web of Science Citation Database Method, and Reference Source Trend of Citation Total Citations Since Publication Average Citations per year A. Chou, TC & Talalay, P Adv. Eng. Regul. 1984; 22:27-55 [ME & CI Theory] , B. Chou, TC Pharmacol. Rev. 2006;58: [CI Review] , C. Chou TC Cancer Res. 2010; 70: [CI Perspectives] , D. Berenbaum, MC Pharmacol. Rev. 1989; 41: E. Bliss, CI Ann. Appl. Biol. 1939; 26: F. Greco, WR et al Pharamacol. Rev. 1995; 47: G. Steel GG & Peckham MJ Int. J. Radiant. Oncol. BioPhys. 1979; 5: H. Elion GB, Singer S & Hitchings GH J. Biol. Chem. 1954; 208: I. Tallarida, RJ J. Pharmacol. Exp. Ther. 2001; 298: J. Prichard, MN & Shipman C Jr Antiviral Res. 1990; 14: K. Webb J.L. Acad. Press. 1963; 1: 66-79, # 4.5 L. Loewe, S Pharmacol. Rev. 1957; 9: *Based on Thomson Reuters Web of Science Core Collection, as of June 10, (Citation numbers are higher in Google Scholar Citations). #Based on Google Scholar Citations, as of June 10, 2017.

8 Number of Cumulative Citations Time Course of Cumulative Citations of Chou TC & Talalay P Adv. Enz. Regul. 22: 27-55, 1984 (Thomson-Reuters Web of Science) Prof. Carl Cori (Nobel- 1947) asked for preprint. It received only 1 citation in 1 st year, 5 citations in 2 nd year. Now 33 years later, it received a total of 4,112 citations in 778 journals. [The 1 st 10 Years Received only 404 Citations] Elsevier News Release: March 16, 2016 Chou & Talalay Paper from 1984 Makes History. One of the most cited theoretical papers in all fields

9 Scopus Analysis: Chou TC s Publications Cited by Papers from Institutional Affiliations

10 T.C. Chou Web Sites Thomson-Reuters Web of Science: Google Search: Ting-Chao Chou Ting-Chao Chou - Google Scholar Citations Wikipedia: Ting-Chao Chou [For Free Download] For Philosophy:

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